NeoplasmsPhase 1NCT02817633
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
A Phase 1 study testing TSR-022, Nivolumab and TSR-042 in people with Neoplasms, run by Tesaro, Inc. at 89 sites in 3 countries.
Trial summary
This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- TSR-022, Nivolumab and TSR-042
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 89 sitesin 3 countries
- Study dates
- 8 Jul 2016to 1 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is at least 18 years of age.
- Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication or be of non-childbearing potential.
- Participant has an ECOG performance status of less than or equal to (<=)1.
- Participant has adequate organ function.
- Inclusion Criteria for Participants in Part 1 and Part 2 Cohorts A, B, and C:
- Participant with advanced or metastatic solid tumor who meets the requirements for the part of the study/cohort he/she will participate in, as follows:
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- Part 2: Histologically proven advanced (unresectable) or metastatic solid tumor that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 criteria Inclusion Criteria for Participants in Part 2 Cohort D
- Participants with advanced or metastatic non-small cell lung carcinoma (NSCLC) that is measurable by CT or MRI per RECIST version 1.1 criteria and meet the following criteria:
- NSCLC histology includes squamous or non-squamous cell carcinoma.
- Participants have received no more than 2 prior lines of therapy, which must include a platinum-based chemotherapy (for example [e.g.], cisplatin, carboplatin) and an anti- programmed death-ligand 1 (PD-L1) antibody.
- Participants must have documented radiographic progression by RECIST version 1.1 criteria on prior anti-programmed cell death protein (PD-1) or anti-PD-L1 therapy.
- Biopsies -All participants enrolled must undergo a biopsy prior to study entry, and the biopsy tissue must be submitted to the central laboratory for all participants in order to determine T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) expression level prior to first dose. If a participant has had a biopsy prior to entering the 35-day screening period and within approximately 12 weeks of study treatment, that biopsy may be accepted as the Baseline fresh biopsy.
- Participant is greater than or equal to (>=)18 years old, is able to understand the study procedures, and agrees to participate in the study by providing written informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and protocol.
- Participant has histologically or cytologically proven advanced or metastatic NSCLC, and only squamous or non-squamous cell carcinoma.
- Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum-based (eg, cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or anti-PD-L1 antibody (no other biologic agents alone or in combination; novel combinations are not allowed). Participants previously treated with targeted therapies, including angiogenesis inhibitors (eg, bevacizumab, ramucirumab, lenvatinib), are not eligible.
- Participant has measurable disease, that is, presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if disease progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible.
- Participant has documented radiological disease progression on prior platinum-based chemotherapy and on prior anti-PD-1 or anti-PD-L1 therapy according to RECIST v1.1.
- Participant agrees to submit an archival formalin fixed paraffin embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
- Participant has an ECOG performance status score of 0 or 1.
- Participant has a life expectancy of at least 3 months and is anticipated to be able to complete 4 cycles of docetaxel treatment.
- Participant has adequate organ function as defined in the protocol
- Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Histologically confirmed locally advanced or metastatic and/or unresectable Hepatocellcular Carcinoma (HCC)
- Barcelona Clinic Liver Cancer Stage B or C
- Cirrhosis grade of Child-Pugh Class A
- No prior systemic therapy for HCC
- Documented HBV testing at screening, including hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAB) and hepatitis B core antibody (HBcAb). Participants with a positive HBsAg will require negative hepatitis B virus (HBV) DNA testing at screening.
- Participants with chronic HBV infection (HBsAg +) are required to be receiving effective antiviral therapy (i.e., with Tenofovir or Entecavir) for at least 14 days with willingness to continue for the length of the study and have HBV deoxyribonucleic acid (DNA) less than 100 International Units Per Milliliter (IU/mL) within 28 days prior to initiation of study treatment.
- Participants with chronic HBV infection (HBsAg+) require documented Hepatitis D virus (HDV) antibody testing conducted at screening. If HDV antibody is positive, then HDV ribonucleic acid (RNA) must be negative to participate.
- Participants with a negative HBsAg and positive HBcAb result are eligible only if HBV DNA is negative (Past HBV participants).
- Documented hepatitis C virus (HCV) antibody testing conducted at screening. If HCV antibody is positive, then HCV RNA must be negative. Participants with recently treated HCV prior to study start must be greater than (>)12 weeks from final HCV treatment.
- Must have measurable disease, defined as at least one tumor lesion that can be accurately measured according to RECIST v1.1
- Participant agrees to submit an archival FFPE tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
- Participants are also encouraged, but not required, to have a fresh tumor tissue biopsy of a primary or metastatic tumor prior to dosing (samples will be used to enable biomarker analysis).
- International normalized ratio (INR) or prothrombin time (PT) <= 2× upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) <=2×ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Negative human immunodeficiency virus (HIV) test at screening The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Who cannot join
- History of Grade greater than or equal to (>=)3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
- Participant has known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Participant has a known additional malignancy that progressed or required active treatment within the last 2 years. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the Medical Monitor.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy.
- Participant is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment.
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
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- A participant with negative (as determined by Central Testing Lab) or unevaluable TIM-3 expression from tissue obtained prior to study entry will not be eligible for the study.
- Participant has received prior therapy as defined below:
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE.
- Prior treatment with an anti-lymphocyte activation gene (LAG)-3 or anti-TIM-3.
- Radiologic or clinical progression <= 8 weeks after initiation of prior anti-PD-1 or anti-PD-L1 antibody.
- Participants with known epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, or receptor tyrosine kinase (ROS1) mutation.
- Participant has received a vaccine other than a vaccine against severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) infection ("Coronavirus Disease 2019" [COVID-19]) within 7 days of planned start of study therapy. The use of all COVID-19 vaccines is allowed, with the exception of COVID-19 vaccines using the recombinant adenoviral vector platform within 30 days of planned start of study therapy. If a COVID-19 vaccine using this platform is to be administered within 30 days of planned start of study therapy, this must first be discussed with and approved by the Sponsor's Medical Monitor.
- Participant has been previously treated with an anti PD 1, anti PD L1, or anti PD L2 agent that resulted in permanent discontinuation due to an AE
- Participant has been previously treated with an anti TIM-3 or anti cytotoxic T lymphocyte-associated protein 4 (CTLA 4) agent or docetaxel.
- Participant has a documented sensitizing EGFR, ALK, or ROS-1 mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
- Participant had radiological or clinical disease progression (that is [ie,] worsening performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation of prior anti PD 1 or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
- Participant has received radiation to the lung that is >30 Gray (Gy) within 6 months prior to the first dose of study treatment.
- Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
- Participant has an additional malignancy or a history of prior malignancy, with the exception of adequately treated basal or squamous skin cancer, cervical carcinoma in situ, or bladder carcinoma in situ without evidence of disease, or had a malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.
- Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiologically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
- Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment:
- Presence of hepatitis B surface antigen.
- Presence of hepatitis C antibody in the absence of an Ribonucleic acid (RNA) test for hepatitis C virus.
- Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
- Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy of prednisone, or equivalent, for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Participant has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.
- Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary.
- Participant does not meet requirements per local prescribing guidelines for receiving treatment with docetaxel, including severe hypersensitivity reactions to drugs formulated with polysorbate 80.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter.
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Participant must not have had major surgery <= 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
- Participants must not have received investigational therapy <= 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
- Active or untreated central nervous system (CNS) and leptomeningeal metastases
- Prior therapy with any medication targeting PD-1, PD-L1, or TIM-3
- Participant must not have a known hypersensitivity to TSR-042 and TSR-022 components or excipients.
- Participants with active malignancy (other than HCC) or a prior malignancy within the past 2 years are excluded. Participants with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are eligible
- Participant must not have serious, uncontrolled medical disorder, or nonmalignant systemic disease as determined by the treating physician. Examples include, but are not limited to uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
- Has a history or evidence of cardiac abnormalities within the 6 months prior to enrollment, including:
- Serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second-degree (Type II) or third-degree atrioventricular (AV) block.
- Cardiomyopathy, myocarditis, myocardial infarction, acute coronary syndromes (including angina pectoris), coronary angioplasty, stenting, or bypass grafting.
- Congestive heart failure [New York Heart Association (NYHA) Class III or IV]
- Symptomatic pericarditis
- Known history of HIV infection
- Active tuberculosis infection or other microbial infection or any active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
- Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (. i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- History of idiopathic pulmonary fibrosis, interstitial lung disease, bronchial asthma, organizing pneumonia, bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic pneumonitis
- History of organ transplantation including allogeneic bone marrow transplantation
- Participant has a diagnosis of immunodeficiency or has been receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
- Participant has received a live vaccine within 7 days of initiating protocol therapy. Seasonal flu vaccines that do not contain live virus and COVID 19 vaccines are permitted.
- Psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant, lactating, breastfeeding, or intending to become pregnant during the study and for 150 days after the study
Trial locations and contacts
89 sites in 3 countries.
89 sites in 3 countries
United States64 sites
GSK Investigational Site
Arlington Heights, Illinois, 60005
GSK Investigational Site
Atlanta, Georgia, 30322
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Aurora, Colorado, 80012
GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Bethlehem, Pennsylvania, 18015
GSK Investigational Site
Boston, Massachusetts, 02114
GSK Investigational Site
Charleston, South Carolina, 29425
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Cincinnati, Ohio, 45242
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Encinitas, California, 92024
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Fairfax, Virginia, 22031
GSK Investigational Site
Florissant, Missouri, 63031
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Goodyear, Arizona, 85338
GSK Investigational Site
Greenville, South Carolina, 29605
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Jacksonville, Florida, 32224
GSK Investigational Site
Kennewick, Washington, 99336
GSK Investigational Site
Longview, Texas, 75601
GSK Investigational Site
Los Angeles, California, 90024
GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
McAllen, Texas, 78503-1298
GSK Investigational Site
Miami, Florida, 33140
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
New Haven, Connecticut, 06511
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Niles, Illinois, 60714
GSK Investigational Site
Pikeville, Kentucky, 41501
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232
GSK Investigational Site
Puyallup, Washington, 98373
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Marcos, California, 92069
GSK Investigational Site
Sarasota, Florida, 34232
GSK Investigational Site
Scottsdale, Arizona, 85258
GSK Investigational Site
Seattle, Washington, 98111
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
St Louis, Missouri, 63129
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tampa, Florida, 33612
GSK Investigational Site
Temple, Texas, 76508
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Toledo, Ohio, 43623
GSK Investigational Site
Tucson, Arizona, 85704
GSK Investigational Site
Tucson, Arizona, 85711
GSK Investigational Site
Tyler, Texas, 75702
GSK Investigational Site
Vancouver, Oregon, 97213-2982
GSK Investigational Site
Washington D.C., District of Columbia, 20007
GSK Investigational Site
Wheaton, Maryland, 20850
GSK Investigational Site
Whittier, California, 90606
GSK Investigational Site
Wichita, Kansas, 67214
Spain20 sites
GSK Investigational Site
Barcelona, 08017
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 8035
GSK Investigational Site
Girona, 17007
GSK Investigational Site
Jerez de la Frontera, 11407
GSK Investigational Site
L'Hospitalet de Llobrega, 08908
GSK Investigational Site
Las Palmas de Gran Canar, 35016
GSK Investigational Site
Madrid, 28027
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Madrid, 28222
GSK Investigational Site
Málaga, 29010
GSK Investigational Site
Palma de Mallorca, 07120
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Santander, 39008
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Valencia, 46010
GSK Investigational Site
Valencia, 46026
GSK Investigational Site
Zaragoza, 50009
South Korea5 sites
GSK Investigational Site
Daegu, 42601
GSK Investigational Site
Seoul, 02841
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 06351
GSK Investigational Site
Seoul, 7061
About this study
Official title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)
This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy.
- Conditions
- Neoplasms
- Keywords
- TSR-022, Nivolumab, Advanced solid tumors, Metastatic solid tumors, Immunotherapy, Colorectal cancer, Non-small cell lung cancer, Melanoma, TSR-033, TSR-042, Hepatocellular carcinoma cancer, Docetaxel
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSR-022Drug
TSR-022 will be administered.
NivolumabDrug
Nivolumab will be administered.
TSR-042Drug
TSR-042 will be administered.
TSR-033Drug
TSR-033 will be administered.
DocetaxelDrug
Docetaxel will be administered.
PemetrexedDrug
Pemetrexed will be administered.
CisplatinDrug
Cisplatin will be administered.
CarboplatinDrug
Carboplatin will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: TSR-022 monotherapy | Experimental | Not described Receives: Drug: TSR-022 |
| Part 1b: TSR-022 in combination with nivolumab | Experimental | Not described Receives: Drug: TSR-022; Drug: Nivolumab |
| Part 1c: TSR-022 in combination with TSR-042 | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042 |
| Part 1d: TSR-022 in combination with TSR-042 and TSR-033 | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042; Drug: TSR-033 |
| Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1) | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042 |
| Part 1f: TSR-022 in combination with TSR-042 and Docetaxel | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042; Drug: Docetaxel |
| Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042; Drug: Pemetrexed; Drug: Cisplatin |
| Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042; Drug: Pemetrexed; Drug: Carboplatin |
| Part 2: Cohort A Melanoma-TSR-022 as monotherapy | Experimental | Not described Receives: Drug: TSR-022 |
| Part 2: Cohort A Melanoma-TSR-022 with TSR-042 | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042 |
| Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapy | Experimental | Not described Receives: Drug: TSR-022 |
| Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042 | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042 |
| Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapy | Experimental | Not described Receives: Drug: TSR-022 |
| Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042 | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042 |
| Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042 | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042 |
| Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel | Experimental | Not described Receives: Drug: TSR-022; Drug: Docetaxel |
| Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042 | Experimental | Not described Receives: Drug: TSR-022; Drug: TSR-042 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs)
Measured: Up to 28 days
Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs)
Measured: Up to 42 days
Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs)
Measured: Up to 21 days
Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs)
Measured: Up to 2 years
Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications
Measured: Up to 2 years
Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Measured: Up to 2 years
Secondary outcomes (45)
Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1
Measured: Up to 2 years
Part 2 (A, B, C, D): ORR by Immune related RECIST (irRECIST)
Measured: Up to 2 years
Part 2: Duration of response (DOR) by RECIST v 1.1
Measured: Up to 2 years
Part 2 (A, B, C, D): DOR by irRECIST
Measured: Up to 2 years
Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1
Measured: Up to 2 years
Part 2 (A, B, C, D): DCR by irRECIST
Measured: Up to 2 years
Part 2: Progression-free survival (PFS) by RECIST v 1.1
Measured: Up to 2 years
Part 2 (A, B, C, D): PFS by irRECIST
Measured: Up to 2 years
Parts 1 and 2 (A, B, C, D, E, F): Serum concentration of TSR-022
Measured: Up to 2 years
Part 1d: Serum concentration of TSR-033
Measured: Up to 2 years
Part 1 (c, d, e, f, g, h): Serum concentration of TSR-042
Measured: Up to 2 years
Part 2 (A, B, C, D, F): Serum concentration of TSR-042
Measured: Up to 2 years
Part 2: Overall survival (OS)
Measured: Up to 2 years
Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy
Measured: Up to 2 years
Part 1b: Cmin of TSR-022 in combination with nivolumab
Measured: Up to 2 years
Part 1c: Cmin of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033
Measured: Up to 2 years
Part 2F: Cmin of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy
Measured: Up to 2 years
Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab
Measured: Up to 2 years
Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033
Measured: Up to 2 years
Part 2F: AUC (0-inf) of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy
Measured: Up to 2 years
Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab
Measured: Up to 2 years
Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033
Measured: Up to 2 years
Part 2F: AUC (0-last) of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy
Measured: Up to 2 years
Part 1b: t1/2 of TSR-022 and in combination with nivolumab
Measured: Up to 2 years
Part 1c: t1/2 of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033
Measured: Up to 2 years
Part 2F: t1/2 of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy
Measured: Up to 2 years
Part 1b: AUCtau of TSR-022 and in combination with nivolumab
Measured: Up to 2 years
Part 1c: AUCtau of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033
Measured: Up to 2 years
Part 2F: AUCtau of TSR-022 in combination with TSR-042
Measured: Up to 2 years
Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022
Measured: Up to 2 years
Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022
Measured: Up to 2 years
Part 1 (c, d, e, f, g, h): Number of participants with ADA to TSR-042
Measured: Up to 2 years
Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042
Measured: Up to 2 years
Part 1d: Number of participants with ADA to TSR-033
Measured: Up to 2 years
Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death
Measured: Up to 2 years
Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP)
Measured: Baseline, and up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start8 Jul 2016
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a multi-center, open-label, first-in-human Phase 1 study.
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tesaro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817633
- Sponsor's protocol ID
- 213348
- Other IDs
- 2018-002143-29, 2018
- Status last verified
- Oct 2025
- First submitted
- 22 Jun 2016
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)
- ClinicalTrials.gov ID
- NCT02817633
- Acronym / sponsor ID
- 213348
- Conditions
- Neoplasms
- Keywords
- TSR-022, Nivolumab, Advanced solid tumors, Metastatic solid tumors, Immunotherapy, Colorectal cancer, Non-small cell lung cancer, Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 17
- Model description
- This is a multi-center, open-label, first-in-human Phase 1 study.
| Arm | Type | Receives |
|---|---|---|
| Part 1a: TSR-022 monotherapy | Experimental | Drug: TSR-022 |
| Part 1b: TSR-022 in combination with nivolumab | Experimental | Drug: TSR-022, Drug: Nivolumab |
| Part 1c: TSR-022 in combination with TSR-042 | Experimental | Drug: TSR-022, Drug: TSR-042 |
| Part 1d: TSR-022 in combination with TSR-042 and TSR-033 | Experimental | Drug: TSR-022, Drug: TSR-042, Drug: TSR-033 |
| Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1) | Experimental | Drug: TSR-022, Drug: TSR-042 |
| Part 1f: TSR-022 in combination with TSR-042 and Docetaxel | Experimental | Drug: TSR-022, Drug: TSR-042, Drug: Docetaxel |
| Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin | Experimental | Drug: TSR-022, Drug: TSR-042, Drug: Pemetrexed, Drug: Cisplatin |
| Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin | Experimental | Drug: TSR-022, Drug: TSR-042, Drug: Pemetrexed, Drug: Carboplatin |
| Part 2: Cohort A Melanoma-TSR-022 as monotherapy | Experimental | Drug: TSR-022 |
| Part 2: Cohort A Melanoma-TSR-022 with TSR-042 | Experimental | Drug: TSR-022, Drug: TSR-042 |
| Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapy | Experimental | Drug: TSR-022 |
| Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042 | Experimental | Drug: TSR-022, Drug: TSR-042 |
| Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapy | Experimental | Drug: TSR-022 |
| Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042 | Experimental | Drug: TSR-022, Drug: TSR-042 |
| Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042 | Experimental | Drug: TSR-022, Drug: TSR-042 |
| Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel | Experimental | Drug: TSR-022, Drug: Docetaxel |
| Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042 | Experimental | Drug: TSR-022, Drug: TSR-042 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Participant is at least 18 years of age.
- Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication or be of non-childbearing potential.
- Participant has an ECOG performance status of less than or equal to (<=)1.
- Participant has adequate organ function.
- Participant with advanced or metastatic solid tumor who meets the requirements for the part of the study/cohort he/she will participate in, as follows:
Key exclusion criteria (52 listed)
- History of Grade greater than or equal to (>=)3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
- Participant has known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Participant has a known additional malignancy that progressed or required active treatment within the last 2 years. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the Medical Monitor.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy.
- Participant is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSR-022TSR-022 will be administered. | Drug | Part 1a: TSR-022 monotherapy, Part 1b: TSR-022 in combination with nivolumab, Part 1c: TSR-022 in combination with TSR-042, Part 1d: TSR-022 in combination with TSR-042 and TSR-033, Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1), Part 1f: TSR-022 in combination with TSR-042 and Docetaxel, Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin, Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin, Part 2: Cohort A Melanoma-TSR-022 as monotherapy, Part 2: Cohort A Melanoma-TSR-022 with TSR-042, Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042, Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel, Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042, Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042, Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapy, Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapy, Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042 |
| NivolumabNivolumab will be administered. | Drug | Part 1b: TSR-022 in combination with nivolumab |
| TSR-042TSR-042 will be administered. | Drug | Part 1c: TSR-022 in combination with TSR-042, Part 1d: TSR-022 in combination with TSR-042 and TSR-033, Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1), Part 1f: TSR-022 in combination with TSR-042 and Docetaxel, Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin, Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin, Part 2: Cohort A Melanoma-TSR-022 with TSR-042, Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042, Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042, Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042, Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042 |
| TSR-033TSR-033 will be administered. | Drug | Part 1d: TSR-022 in combination with TSR-042 and TSR-033 |
| DocetaxelDocetaxel will be administered. | Drug | Part 1f: TSR-022 in combination with TSR-042 and Docetaxel, Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel |
| PemetrexedPemetrexed will be administered. | Drug | Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin, Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin |
| CisplatinCisplatin will be administered. | Drug | Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin |
| CarboplatinCarboplatin will be administered. | Drug | Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin |
Primary outcome
Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs)
Time frame: Up to 28 days
Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs)
Time frame: Up to 42 days
Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs)
Time frame: Up to 21 days
Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs)
Time frame: Up to 2 years
Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications
Time frame: Up to 2 years
Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Time frame: Up to 2 years
45 secondary outcomes
Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1
Time frame: Up to 2 years
Part 2 (A, B, C, D): ORR by Immune related RECIST (irRECIST)
Time frame: Up to 2 years
Part 2: Duration of response (DOR) by RECIST v 1.1
Time frame: Up to 2 years
Part 2 (A, B, C, D): DOR by irRECIST
Time frame: Up to 2 years
Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1
Time frame: Up to 2 years
Part 2 (A, B, C, D): DCR by irRECIST
Time frame: Up to 2 years
Part 2: Progression-free survival (PFS) by RECIST v 1.1
Time frame: Up to 2 years
Part 2 (A, B, C, D): PFS by irRECIST
Time frame: Up to 2 years
Parts 1 and 2 (A, B, C, D, E, F): Serum concentration of TSR-022
Time frame: Up to 2 years
Part 1d: Serum concentration of TSR-033
Time frame: Up to 2 years
Part 1 (c, d, e, f, g, h): Serum concentration of TSR-042
Time frame: Up to 2 years
Part 2 (A, B, C, D, F): Serum concentration of TSR-042
Time frame: Up to 2 years
Part 2: Overall survival (OS)
Time frame: Up to 2 years
Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy
Time frame: Up to 2 years
Part 1b: Cmin of TSR-022 in combination with nivolumab
Time frame: Up to 2 years
Part 1c: Cmin of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033
Time frame: Up to 2 years
Part 2F: Cmin of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy
Time frame: Up to 2 years
Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab
Time frame: Up to 2 years
Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033
Time frame: Up to 2 years
Part 2F: AUC (0-inf) of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy
Time frame: Up to 2 years
Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab
Time frame: Up to 2 years
Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033
Time frame: Up to 2 years
Part 2F: AUC (0-last) of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy
Time frame: Up to 2 years
Part 1b: t1/2 of TSR-022 and in combination with nivolumab
Time frame: Up to 2 years
Part 1c: t1/2 of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033
Time frame: Up to 2 years
Part 2F: t1/2 of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy
Time frame: Up to 2 years
Part 1b: AUCtau of TSR-022 and in combination with nivolumab
Time frame: Up to 2 years
Part 1c: AUCtau of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033
Time frame: Up to 2 years
Part 2F: AUCtau of TSR-022 in combination with TSR-042
Time frame: Up to 2 years
Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022
Time frame: Up to 2 years
Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
89 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TSR-022, Nivolumab and TSR-042 in people with Neoplasms, run by Tesaro, Inc. at 89 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Spain, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs) (time frame: Up to 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.