Unresectable MelanomaPhase 2NCT04337931
A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma
A Phase 2 study testing sotigalimab in people with Unresectable Melanoma and Metastatic Melanoma, run by Apexigen America, Inc. at 19 sites in 2 countries.
Trial summary
This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of sotigalimab (APX005M) administered at 2 different schedules to adult participants with unresectable or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Melanoma, Metastatic Melanoma, Cancer
- What is being tested?
- sotigalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 12 Jun 2019to 2 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed unresectable or metastatic melanoma
- Subjects with BRAF activating mutation must have received a BRAF inhibitor and/or MEK inhibitor regimen prior to study entry
- Signed written informed consent approved by the relevant local ethics committee(s)
- Male or female ≥18 years old at time of consent
- Measurable disease by RECIST 1.1
- For Cohort 3 only, subjects must have at least 3 measurable target lesions
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- ECOG performance status of 0 or 1
- Resolution of all disease or prior treatment-related toxicities to Grade ≤1, with the exception of alopecia, Grade 2 neuropathy and laboratory abnormalities (parameters below apply). If subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention
- Adequate organ function within 14 days prior to first dose of investigational therapy(ies):
- WBC ≥2 x 109/L in absence of growth factor support
- ANC ≥1.0 x 109/L in absence of growth factor support
- Platelet count ≥100 x 109/L
- Hemoglobin ≥9 g/dL
- Serum creatinine ≤1.5 mg/dL
- Calculated (using the formula of local laboratory) or creatinine clearance ≥60 mL/min
- AST and ALT ≤2.5 x ULN
- Total bilirubin ≤1.5 x ULN, or direct bilirubin ≤ULN with total bilirubin levels >1.5 x ULN
- INR or PT ≤1.5 x ULN unless receiving anticoag therapy PT or PTT is within therap, range
- aPTT ≤1.5 x ULN unless receiving anticoag therapy PT or PTT is within therap range
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to first dose of investigational therapy(ies) and a negative urine pregnancy test within the 3 days prior to first dose of investigational therapy(ies), or a negative serum pregnancy test within the 3 days prior to first dose of investigational therapy(ies)
- Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of study treatment and 5 months after the last dose of investigational therapy(ies). Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment and 7 months after the last dose of investigational therapy(ies)
- Available archived or fresh tumor tissue sample for biomarker analysis. Cohort 3, only available archived tissue is required.
- For subjects that consent to collection of tumor biopsies at study entry and before the first scheduled tumor assessment, primary or metastatic tumor that can be safely biopsied. Up to 18 subjects (6 subjects within each cohort) should consent to fresh core biopsies.
Who cannot join
- Prior Therapy:
- Cohorts 1 and 2 only: Previous exposure to any immunomodulatory agent (such as CTLA-4, PD-1/PD-L1, IDO inhibitors, interferon, CD40 agonist etc.).
- Cohort 3 only: Prior therapy with a CD40 agonist. Any number of prior lines of therapy are eligible. A minimum washout period of 21 days from last line of therapy until investigational therapy(ies) administration should be observed.
- Second malignancy (solid or hematologic) within the past 3 years except locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- Active, known, clinically serious infections (≥ Grade 2 according to NCI-CTCAE v4.03) within the 14 days prior to first dose of investigational therapy(ies)
- Use of systemic corticosteroids or other systemic immunosuppressive drugs within 28 days prior to first dose of investigational therapy(ies) (except inhaled corticosteroids)
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- The use of physiologic doses of corticosteroids may be approved /w consultation Medical Monitor (or designee)
- Major surgery within 4 weeks prior to first dose of sotigalimab
- Concurrent treatment with any anticancer agent and palliative radiation, unless approved by MM (or designee)
- History of allogeneic bone marrow transplantation
- Active, known or suspected autoimmune disease
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
- History of interstitial lung disease
- History of sensitivity or allergy to mAbs or IgG
- Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to the first dose of investigational therapy(ies)
- History of any thromboembolic event within 3 months prior to first dose of investigational therapy(ies) or active coagulopathy
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with untreated brain metastases ≤3mm that are asymptomatic, do not have significant edema, cause shift, and do not require steroids or anti-seizure medications are eligible after discussion with the Medical Monitor. Lesions of any size in posterior fossa are excluded. Subjects with previously treated brain metastases may participate provided they are stable after treatment (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using corticosteroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
- Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
- Has received a live (attenuated) vaccine within 30 days prior to the first dose of investigational therapy(ies). Seasonal flu vaccines that do not contain live virus and COVID 19 vaccines are permitted (see Section 3.2.3.4)
- Has participated in another clinical trial of an investigational drug (or a medical device) within 30 days of study enrollment
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Any clinically significant psychiatric, social, or medical condition that, in the opinion of the Investigator, could increase subject's risk, interfere with protocol adherence, or affect a subject's ability to give informed consent.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Spain17 sites
Hospital Universitario San Juan De Alicante
Alicante
Hospital Universitari Quirón Dexeus
Barcelona
Hospital Universitari Vall D'Hebron
Barcelona
Hospital Universitario Insular De Gran Canaria
Las Palmas de Gran Canaria
Clínica Universidad De Navarra Sede Madrid
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Madrid Sanchinarro
Madrid
Hospital Regional Universitario de Málaga
Málaga
Hospital Clínico Universitario Virgen De La Arrixaca
Murcia
Hospital Universitario De Canarias
Santa Cruz de Tenerife
Hospital Universitario Marqués De Valdecilla
Santander
Consorcio Hospital General Universitario de Valenc
Valencia
Hospital Universitario Dr. Peset
Valencia
Instituto Valenciano de Oncología
Valencia
Complexo Hospitalario Universitario De Vigo Álvaro Cunqueiro
Vigo
Hospital Universitario Miguel Servet
Zaragoza
Poland2 sites
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan
Centrum Onkologii - Instytutu im. Marii Skłodowskiej - Curie w Warszawie
Warsaw
About this study
Official title: A Phase II Multicenter, Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody Sotigalimab (APX005M) With or Without Stereotactic Body Radiation Therapy in Adults With Unresectable or Metastatic Melanoma
This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of sotigalimab (APX005M) administered at 2 different schedules to adult participants with unresectable or metastatic melanoma. Participants who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts with different sotigalimab administration schedules as long as both are open for enrollment. Participants who have failed any number of prior lines of therapy will be assigned to a 3rd cohort of sotigalimab in combination with radiation therapy.
Read the detailed description
This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of Sotigalimab administered at 2 different schedules to adult participants with unresectable or metastatic melanoma who have not received prior immunotherapy. Enrolled participants will be alternately assigned to one of the following 2 cohorts (groups) as long as both cohorts are open.
Cohort 1: APX005M administered IV at 0.3 mg/kg every 3 weeks (21-day cycle) Cohort 2: APX005M administered IV at 0.3 mg/kg every 2 weeks (14-day cycle) Sotigalimab in combination with stereotactic body radiation therapy (SBRT) in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy will be assigned to Cohort 3: Sotigalimab administered IV at 0.3 mg/kg in combination with radiation therapy every 2 weeks (14 day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).
Primary Objective
- Evaluate the overall response rate (ORR) by RECIST 1.1 measurements in each of the cohorts.
Secondary Objectives
- Evaluate the safety of sotigalimab alone or in combination with radiation therapy in each cohort
- Evaluate ORR by modified RECIST 1.1 for immune-based therapeutics (iRECIST) in each cohort
- Evaluate median duration of response (DOR) in each cohort
- Conditions
- Unresectable Melanoma, Metastatic Melanoma, Cancer, Cancer of Skin, Melanoma, Melanoma (Skin)
- Being tested
- sotigalimab
- Keywords
- CD40, Immunotherapy, APX005M, sotigalimab
- Medical subject headings
- Melanoma, Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sotigalimabDrug
Also called APX005M
Sotigalimab is a CD40 agonistic monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Sotigalimab administered IV at 0.3 mg/kg every 3 weeks (21 day) treatment cycles Receives: Drug: sotigalimab |
| Cohort 2 | Experimental | Sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14 day) treatment cycles Receives: Drug: sotigalimab |
| Cohort 3 | Experimental | Metastatic melanoma participants who have failed any number of prior lines of therapy with minimum 3 measurable lesions.
Sotigalimab administered IV at 0.3mg/kg in combination with Stereotactic Body Radiation Therapy (SBRT) every 2 weeks (14-day) treatment cycles up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day) treatment cycles. Receives: Drug: sotigalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Overall Response Rate (ORR)
The percentage of participants having reached a confirmed Complete Response (CR) or Partial Response (PR) by RECIST 1.1, relative to the number of participants belonging to the Efficacy Population. Confidence Intervals (CIs) were calculated using exact (Clopper-Pearson) method.
CR: Disappearance of all target lesions and nontarget (NT) lesions; PR: >30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions.
Measured: 12 months
Secondary outcomes (2)
Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST 1.1) Overall Response Rate (iORR)
The percentage of participants having reached an immune confirmed Complete Response (iCR) or Partial Response (iPR) by iRECIST 1.1, relative to the number of participants belonging to the Efficacy Population. CIs were calculated using exact (Clopper-Pearson) method.
iCR: Disappearance of all target lesions and NT lesions; iPR: >30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions.
Measured: 12 months
RECIST 1.1 Duration of Response (DoR)
The DoR was defined as the time (in months) from the first evidence of confirmed objective response (CR or PR) to the event or censoring date. An event was defined as the first documentation of progression disease (PD; disease progression assessed based on tumor assessment or clinical progression) or death due to any cause, whichever occurs earlier. Median DoR was calculated using Kaplan-Meier analysis. CIs were calculated using exact (Clopper-Pearson) method.
CR: Disappearance of all target lesions and NT lesions; PR: >30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions; PD: >20% increase in the sum of the longest diameter of target lesions and an absolute increase of ≥5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start12 Jun 2019
- Primary completion29 Jul 2022
- Study completion2 Aug 2022
Why it stopped: Business decision (not due to safety reason).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unresectable MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled participants will be alternately assigned to one of the following 2 cohorts (groups) as long as the cohorts are open: Cohort 1: APX005M administered IV at 0.3 mg/kg every 3 weeks (21-day cycle) Cohort 2: APX005M administered IV at 0.3 mg/kg every 2 weeks (14-day cycle) Enrolled participants assigned to Cohorts 1 or 2 that do not receive sotigalimab or are not evaluable for tumor response will be replaced in that cohort before assigning new participants to the other cohort. Cohort 3: Participants who have failed any number of prior lines of therapy, sotigalimab administered IV at 0.3 mg/kg in combination with radiation therapy every 2 weeks (14 day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apexigen America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337931
- Sponsor's protocol ID
- APX005M-010
- Status last verified
- Jan 2024
- First submitted
- 30 Mar 2020
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody Sotigalimab (APX005M) With or Without Stereotactic Body Radiation Therapy in Adults With Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT04337931
- Acronym / sponsor ID
- APX005M-010
- Conditions
- Unresectable Melanoma, Metastatic Melanoma, Cancer, Cancer of Skin, Melanoma, Melanoma (Skin)
- Keywords
- CD40, Immunotherapy, APX005M, sotigalimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision (not due to safety reason).
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Apexigen America, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Posted 22 Dec 2023
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 multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of sotigalimab (APX005M) administered at 2 different schedules to adult participants with unresectable or metastatic melanoma. Participants who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts with different sotigalimab administration schedules as long as both are open for enrollment. Participants who have failed any number of prior lines of therapy will be assigned to a 3rd cohort of sotigalimab in combination with radiation therapy.
Detailed description
This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of Sotigalimab administered at 2 different schedules to adult participants with unresectable or metastatic melanoma who have not received prior immunotherapy. Enrolled participants will be alternately assigned to one of the following 2 cohorts (groups) as long as both cohorts are open.
Cohort 1: APX005M administered IV at 0.3 mg/kg every 3 weeks (21-day cycle) Cohort 2: APX005M administered IV at 0.3 mg/kg every 2 weeks (14-day cycle) Sotigalimab in combination with stereotactic body radiation therapy (SBRT) in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy will be assigned to Cohort 3: Sotigalimab administered IV at 0.3 mg/kg in combination with radiation therapy every 2 weeks (14 day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).
Primary Objective
- Evaluate the overall response rate (ORR) by RECIST 1.1 measurements in each of the cohorts.
Secondary Objectives
- Evaluate the safety of sotigalimab alone or in combination with radiation therapy in each cohort
- Evaluate ORR by modified RECIST 1.1 for immune-based therapeutics (iRECIST) in each cohort
- Evaluate median duration of response (DOR) in each cohort
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Enrolled participants will be alternately assigned to one of the following 2 cohorts (groups) as long as the cohorts are open: Cohort 1: APX005M administered IV at 0.3 mg/kg every 3 weeks (21-day cycle) Cohort 2: APX005M administered IV at 0.3 mg/kg every 2 weeks (14-day cycle) Enrolled participants assigned to Cohorts 1 or 2 that do not receive sotigalimab or are not evaluable for tumor response will be replaced in that cohort before assigning new participants to the other cohort. Cohort 3: Participants who have failed any number of prior lines of therapy, sotigalimab administered IV at 0.3 mg/kg in combination with radiation therapy every 2 weeks (14 day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: sotigalimabSotigalimab administered IV at 0.3 mg/kg every 3 weeks (21 day) treatment cycles |
| Cohort 2 | Experimental | Drug: sotigalimabSotigalimab administered IV at 0.3 mg/kg every 2 weeks (14 day) treatment cycles |
| Cohort 3 | Experimental | Drug: sotigalimabMetastatic melanoma participants who have failed any number of prior lines of therapy with minimum 3 measurable lesions. Sotigalimab administered IV at 0.3mg/kg in combination with Stereotactic Body Radiation Therapy (SBRT) every 2 weeks (14-day) treatment cycles up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day) treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically or cytologically confirmed unresectable or metastatic melanoma
- Subjects with BRAF activating mutation must have received a BRAF inhibitor and/or MEK inhibitor regimen prior to study entry
- Signed written informed consent approved by the relevant local ethics committee(s)
- Male or female ≥18 years old at time of consent
- Measurable disease by RECIST 1.1
Key exclusion criteria (23 listed)
- Prior Therapy:
- Second malignancy (solid or hematologic) within the past 3 years except locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- Active, known, clinically serious infections (≥ Grade 2 according to NCI-CTCAE v4.03) within the 14 days prior to first dose of investigational therapy(ies)
- Use of systemic corticosteroids or other systemic immunosuppressive drugs within 28 days prior to first dose of investigational therapy(ies) (except inhaled corticosteroids)
- Major surgery within 4 weeks prior to first dose of sotigalimab
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 |
|---|---|---|
| sotigalimabAlso: APX005MSotigalimab is a CD40 agonistic monoclonal antibody | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Overall Response Rate (ORR)
Time frame: 12 months
The percentage of participants having reached a confirmed Complete Response (CR) or Partial Response (PR) by RECIST 1.1, relative to the number of participants belonging to the Efficacy Population. Confidence Intervals (CIs) were calculated using exact (Clopper-Pearson) method. CR: Disappearance of all target lesions and nontarget (NT) lesions; PR: >30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions.
2 secondary outcomes
Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST 1.1) Overall Response Rate (iORR)
Time frame: 12 months
RECIST 1.1 Duration of Response (DoR)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sotigalimab in people with Unresectable Melanoma and Metastatic Melanoma, run by Apexigen America, Inc. at 19 sites in 2 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 23 inclusion and 23 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: stopped early, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Overall Response Rate (ORR) (time frame: 12 months). 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 13 Feb 2024.