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A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma

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

NCT04337931•Apexigen America, Inc.

View on ClinicalTrials.gov

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. 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed unresectable or metastatic melanoma
•2. Subjects with BRAF activating mutation must have received a BRAF inhibitor and/or MEK inhibitor regimen prior to study entry
•3. Signed written informed consent approved by the relevant local ethics committee(s)
•4. Male or female ≥18 years old at time of consent
•5. Measurable disease by RECIST 1.1
•a. For Cohort 3 only, subjects must have at least 3 measurable target lesions
•6. ECOG performance status of 0 or 1
•7. 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
•8. Adequate organ function within 14 days prior to first dose of investigational therapy(ies):
•1. WBC ≥2 x 109/L in absence of growth factor support
+13 more criteria

Exclusion Criteria

•1. Prior Therapy:
•1. 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.).
•2. 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.
•2. 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
•3. 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)
•4. Use of systemic corticosteroids or other systemic immunosuppressive drugs within 28 days prior to first dose of investigational therapy(ies) (except inhaled corticosteroids)
•a. The use of physiologic doses of corticosteroids may be approved /w consultation Medical Monitor (or designee)
•5. Major surgery within 4 weeks prior to first dose of sotigalimab
•6. Concurrent treatment with any anticancer agent and palliative radiation, unless approved by MM (or designee)
•7. History of allogeneic bone marrow transplantation
+13 more criteria

Locations (19)

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

Poznan, Poland

Centrum Onkologii - Instytutu im. Marii Skłodowskiej - Curie w Warszawie

Warsaw, Poland

Hospital Universitario San Juan De Alicante

Alicante, Spain

Hospital Universitari Quirón Dexeus

Barcelona, Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Universitario Insular De Gran Canaria

Las Palmas de Gran Canaria, Spain

Clínica Universidad De Navarra Sede Madrid

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Madrid Sanchinarro

Madrid, Spain

Key Dates

Start Date

June 12, 2019

Primary Completion Date

July 29, 2022

Completion Date

August 2, 2022

Last Updated

February 13, 2024

Enrollment

ACTUAL participants

Conditions

Unresectable MelanomaMetastatic MelanomaCancerCancer of SkinMelanomaMelanoma (Skin)

Interventions

sotigalimab

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Advanced Malignant Solid NeoplasmLocally Advanced Pancreatic Carcinoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma