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MelanomaPhase 1NCT03289962

A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

A Phase 1 study testing Autogene cevumeran and Atezolizumab in people with Melanoma and Non-Small Cell Lung Cancer, run by Genentech, Inc. at 33 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Autogene cevumeran and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
33 sitesin 8 countries
Study dates
21 Dec 2017to 1 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>=12 weeks)
  • Adequate hematologic and end-organ function
  • Measured or calculated creatinine clearance >=50 milliliters per minute (mL/min) on the basis of the Cockcroft-Gault glomerular filtration rate estimation
  • Cancer-Specific Inclusion Criteria:
  • Participants with histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
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  • Participants with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks (preferred), or sectioned tissue
  • Participants with measurable disease per RECIST v1.1
  • Additional Inclusion Criteria for Participants in Each Indication-Specific Exploration/Expansion Cohort of Phase 1b:
  • NSCLC Cohorts (CIT-Naive): Participants with histologically confirmed incurable, advanced NSCLC not previously treated with anti-PD-L1/PD-1 and/or with anti-CTLA-4 (investigational or approved), for whom a clinical trial of an investigational agent in combination with an anti-PD-L1/PD-1 antibody is considered an acceptable treatment option (if CIT [including anti-PD-L1/PD-1 agents] is approved as treatment for NSCLC by local regulatory authorities).
  • NSCLC Cohort (CIT-Treated): Participants with histologically confirmed incurable, advanced NSCLC previously treated with anti-PD-L1/PD-1 with or without anti-CTLA-4 (investigational or approved)
  • Triple negative breast cancer (TNBC) Cohort (CIT-Naive): Participants with histologically confirmed incurable, advanced estrogen receptor (ER)-negative, progesterone receptor-negative, and human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the breast (triple-negative) not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved)
  • Colorectal cancer (CRC) Cohort (CIT-Naive): Participants with histologically confirmed incurable, advanced adenocarcinoma of the colon or rectum not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved)
  • Head and neck squamous cell carcinoma (HNSCC) Cohort (CIT-Naive): Participants with histologically confirmed inoperable, locally advanced or metastatic, recurrent, or persistent HNSCC (oral cavity, oropharynx, hypopharnyx, or larynx) not amenable to curative therapy not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved)
  • Urothelial carcinoma (UC) Cohort (CIT-Naive): Participants with histologically confirmed incurable, advanced transitional cell carcinoma of the urothelium including renal pelvis, ureters, urinary bladder, and urethra, not previously treated with anti-PD-L1/PD-1 with or without anti-CTLA-4 (investigational or approved), for whom a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option, if CIT (including anti-PD-L1/PD-1 agents) is approved as treatment for UC by local regulatory authorities
  • UC Cohort (CIT-Treated): Participants with histologically confirmed incurable advanced transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) previously treated with anti-PD-L1/PD-1 with or without anti-CTLA-4 (investigational or approved)
  • Renal cell carcinoma (RCC) Cohort (CIT-Naive): Participants with histologically confirmed incurable, advanced RCC with component of clear cell histology and/or component of sarcomatoid histology not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved)
  • Melanoma Cohort (CIT-Naive in metastatic setting): Participants with histologically confirmed incurable, advanced melanoma not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved) in the metastatic setting
  • Melanoma Cohort (CIT-Treated): Participants with histologically confirmed incurable, advanced melanoma previously treated with anti-PD-L1/ or PD-1 with or without CTLA-4 (investigational or approved)
  • Additional Inclusion Criteria for Participants in the Serial-Biopsy Expansion Cohort of Phase 1b:
  • Participants must have one of the locally advanced or metastatic solid tumor types specified in the protocol.
  • Participants must have accessible lesion(s) that permit a total of two to three biopsies (pretreatment and on-treatment) or one biopsy (on-treatment, if archival tissue can be submitted in place of a pre-treatment biopsy) without unacceptable risk of a significant procedural complication. RECIST lesions should not be biopsied.

Who cannot join

  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
  • Major surgical procedure within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the course of the study
  • Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
  • Previous splenectomy
  • Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)
  • Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study Cancer-Specific Exclusion Criteria
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  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment, with the exceptions as mentioned in the protocol
  • Eligibility based on prior treatment with CIT depends on the mechanistic class of the drug and the cohort for which the participant is being considered, as described below. In addition, all criteria pertaining to adverse events attributed to prior cancer therapies must be met
  • All Cohorts (Dose-Escalation in Phase 1a and Dose-Escalation, Backfill, and Expansion in Phase 1b):
  • Prior neoantigen-specific or whole-tumor cancer vaccines are not allowed, with the exception as specified in protocol
  • Prior treatment with cytokines is allowed provided that at least 6 weeks or 5 half-lives of the drug, whichever is shorter, have elapsed between the last dose and the proposed Cycle 1, Day 1
  • Prior treatment with immune checkpoint inhibitors, immunomodulatory monoclonal antibody (mAbs), and/or mAb-derived therapies is allowed provided that at least 6 weeks (Phase 1a) or 3 weeks (Phase 1b) have elapsed between the last dose and the proposed Cycle 1, Day 1, with the exceptions as specified in protocol Phase Ib Dose-Exploration/Expansion Group Only Cohorts
  • In the non-melanoma CIT-Naive expansion cohort in Phase Ib, prior treatment with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved), is not allowed.
  • In the melanoma CIT-naive in metastatic setting expansion cohort in Phase Ib, prior treatment with anti-PD- L1/PD-1 and/or anti-CTLA-4 (investigational or approved) is not allowed. Prior anti-PD-L1/PD-1 and/or anti-CTLA-4 therapy in the adjuvant setting is allowed provided that there is at least a 6-month treatment-free interval between completion of adjuvant therapy and Cycle 1, Day 1.
  • Prior treatment with immunomodulators, including toll-like receptor (TLR) agonists, inhibitors of indoleamine 2,3-dioxygenase (IDO)/ tryptophan-2,3-dioxygenase (TDO), or agonists of OX40, is allowed provided that at least 5 half-lives of the drug or a minimum of 3 weeks have elapsed between the last dose of the prior treatment and the proposed Cycle 1, Day 1, with the exception as specified in protocol
  • Any history of an immune-mediated Grade 4 adverse event attributed to prior CIT (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase)
  • Any history of an immune-mediated Grade 3 adverse event attributed to prior CIT (other than hypothyroidism managed with replacement therapy) that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred less than or equal to (<=) 6 months prior to Cycle 1 Day 1
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
  • All immune-mediated adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) must have resolved completely to baseline
  • Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
  • Leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death
  • Uncontrolled hypercalcemia
  • Participant has spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to screening
  • Treatment-Specific Exclusion Criteria:
  • History of autoimmune disease with caveats as specified in protocol
  • Treatment with monoamine oxidase inhibitors (MAOIs) within 3 weeks prior to Cycle 1, Day 1
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1
  • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Positive test for human immunodeficiency virus (HIV) infection
  • Active hepatitis B, hepatitis C
  • Known active or latent tuberculosis infection
  • Severe infections within 4 weeks prior to Cycle 1, Day 1
  • Recent infections not meeting the criteria for severe infections within 2 weeks prior to Cycle 1, Day 1
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
  • Known hypersensitivity to the active substance or to any of the excipients in the vaccine
  • Phase 1b and crossover only: History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; Known hypersensitivity to Chinese Hamster Ovary (CHO)-cell products; Allergy or hypersensitivity to components of the atezolizumab formulation

Trial locations and contacts

33 sites in 8 countries.

33 sites in 8 countries

United States15 sites

  • University of Colorado

    Aurora, Colorado, 80045-2517

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Dana Farber Can Ins

    Boston, Massachusetts, 02215

  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

    Las Vegas, Nevada, 89169

  • The Los Angeles Clinic

    Los Angeles, California, 90025

  • Sarah Cannon Res Inst

    Nashville, Tennessee, 37203

  • Yale University Cancer Center, Smilow Cancer Hospital

    New Haven, Connecticut, 06511

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Providence Oncology and Hematology Care Eastside

    Portland, Oregon, 97213

  • UCSF Comprehensive Cancer Ctr

    San Francisco, California, 94143

  • HonorHealth Research Institute ? Bisgrove

    Scottsdale, Arizona, 85258

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Stanford Cancer Center

    Stanford, California, 94305

Other trials in United States

Germany4 sites

  • Universitätsklinikum Essen

    Essen, 45122

  • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT)

    Heidelberg, 69120

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55101

Other trials in Germany

Belgium3 sites

  • UZ Gent

    Ghent, 9000

  • CHU de Liège (Sart Tilman)

    Liège, 4000

  • ZAS Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

United Kingdom3 sites

  • Barts Health NHS Trust - St Bartholomew's Hospital

    London, EC1M 6BQ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Canada2 sites

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands2 sites

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Spain2 sites

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

Sweden2 sites

  • Karolinska Universitetssjukhuset, Solna

    Stockholm, 751 85

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors

This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).

Being tested
Autogene cevumeran, Atezolizumab
Keywords
Neoantigen, Personalized, Atezolizumab, Immunotherapy, Anti-PDL1, Checkpoint Inhibitor
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms, Colorectal Neoplasms, Triple Negative Breast Neoplasms, Kidney Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autogene cevumeranDrug

    Also called RO7198457

    Autogene cevumeran will be administered by intravenous (IV) infusion, in 21-day cycles.

  • AtezolizumabDrug

    Also called Tecentriq, RO5541267, MPDL3280A, An engineered anti-PDL1 antibody

    Atezolizumab will be administered by IV infusion on Day 1 of every 21-day cycle.

Study groups in NCT03289962
Study groupRoleWhat they receive
Phase 1a Flat Dose Escalation: Autogene CevumeranExperimentalParticipants will receive autogene cevumeran at escalated dosages.
Receives: Drug: Autogene cevumeran
Phase 1b Flat Dose Escalation: Autogene Cevumeran + AtezolizumabExperimentalParticipants will receive autogene cevumeran at escalated dosages along with atezolizumab at a fixed dose of 1200 milligrams (mg)
Receives: Drug: Autogene cevumeran; Drug: Atezolizumab
Phase Ib: Dose Exploration: Autogene Cevumeran + AtezolizumabExperimentalNon-small cell lung cancer (NSCLC) or melanoma cancer immunotherapy (CIT)-treated participants will receive autogene cevumeran (at dosage lower than maximum tolerated dose [MTD] based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.
Receives: Drug: Autogene cevumeran; Drug: Atezolizumab
Phase 1b Expansion: Autogene Cevumeran + AtezolizumabExperimentalParticipants with different indications as per inclusion criteria will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.
Receives: Drug: Autogene cevumeran; Drug: Atezolizumab
Phase 1b Expansion: Autogene Cevumeran + Atezolizumab (Serial Biopsy)ExperimentalCIT-naive patients with selected tumor types who consent to optional serial biopsies will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a dixed dose of 1200 mg.
Receives: Drug: Autogene cevumeran; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Dose-Limiting Toxicities (DLTs)

    Measured: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21

  2. MTD/Recommended Phase 2 Dose (RP2D) of Autogene Cevumeran

    Measured: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21

  3. Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline up to end of the study (up to approximately 3 years)

  4. Percentage of Participants with Immune-Mediated Adverse Events (imAEs)

    Measured: Baseline up to end of the study (up to approximately 3 years)

  5. Percentage of Participants by Number of Treatment Cycles Received

    Measured: Baseline up to end of the study (up to approximately 3 years)

  6. Dose Intensity of Autogene Cevumeran

    Measured: Baseline up to end of the study (up to approximately 3 years)

  7. Change from Baseline in Targeted Vital Signs

    Measured: Baseline up to end of study (up to approximately 3 years)

  8. Change from Baseline in Targeted Clinical Laboratory Test Results

    Measured: Baseline up to end of study (up to approximately 3 years)

  9. Change from Baseline in ECGs

    Measured: Baseline up to end of study (up to approximately 3 years)

Secondary outcomes (7)

  1. Percentage of Participants with Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to approximately 3 years)

  2. Duration of Response (DoR) According to RECIST v1.1

    Measured: From first occurrence of a documented objective response (CR or PR) until disease progression or death due to any cause, whichever occurs first (up to approximately 3 years)

  3. Percentage of Participants with Objective Response of CR or PR According to Immune-Modified RECIST

    Measured: Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to approximately 3 years)

  4. DoR According to Immune-Modified RECIST

    Measured: From first occurrence of a documented objective response (CR or PR) until disease progression or death due to any cause, whichever occurs first (up to approximately 3 years)

  5. Progression-Free Survival (PFS) According to RECIST v1.1

    Measured: Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to approximately 3 years)

  6. Overall Survival (OS)

    Measured: Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to approximately 3 years)

  7. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab

    Measured: Pre-infusion (0 hr) until 2 months post treatment discontinuation (up to approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start21 Dec 2017
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

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
Masking
None (open label)
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03289962
Sponsor's protocol ID
GO39733
Other IDs
2017-001475-23, 2017
Status last verified
Jun 2026
First submitted
19 Sep 2017
Last updated
8 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lopez J, Powles T, Braiteh F, Siu LL, LoRusso P, Friedman CF, Balmanoukian AS, Gordon M, Yachnin J, Rottey S, Karydis I, Fisher GA, Schmidt M, Schuler M, Sullivan RJ, Burris HA, Galvao V, Henick BS, Dirix L, Jaeger D, Ott PA, Wong KM, Jerusalem G, Schiza A, Fong L, Steeghs N, Leidner RS, Rittmeyer A, Laurie SA, Gort E, Aljumaily R, Melero I, Sabado RL, Rhee I, Mancuso MR, Muller L, Fine GD, Yadav M, Kim L, Leveque VJP, Robert A, Darwish M, Qi T, Zhu J, Zhang J, Twomey P, Rao GK, Low DW, Petry C, Lo AA, Schartner JM, Delamarre L, Mellman I, Lower M, Muller F, Derhovanessian E, Cortini A, Manning L, Maurus D, Brachtendorf S, Lorks V, Omokoko T, Godehardt E, Becker D, Hawner C, Wallrapp C, Albrecht C, Kroner C, Tadmor AD, Diekmann J, Vormehr M, Jork A, Paruzynski A, Lang M, Blake J, Hennig O, Kuhn AN, Sahin U, Tureci O, Camidge DR. Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial. Nat Med. 2025 Jan;31(1):152-164. doi: 10.1038/s41591-024-03334-7. Epub 2025 Jan 6.

    PubMed 39762422

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autogene cevumeran and Atezolizumab in people with Melanoma and Non-Small Cell Lung Cancer, run by Genentech, Inc. at 33 sites in 8 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 22 inclusion and 40 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: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Germany, Belgium, United Kingdom, Canada and 3 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03289962, which also lists 1 linked publication.

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 8 Jun 2026.

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