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

NCT04337931 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: APX005M-010
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 19

Brief 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.

Conditions

Unresectable Melanoma; Metastatic Melanoma; Cancer; Cancer of Skin; Melanoma; Melanoma (Skin)

Keywords

CD40; Immunotherapy; APX005M; sotigalimab

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST 1.1) Overall Response Rate (iORR)

  12 months

• RECIST 1.1 Duration of Response (DoR)

  12 months

Other Outcomes (1)

• RECIST 1.1 Progression-free Survival (PFS)

  12 months

Study Arms (3)

Cohort 1

EXPERIMENTAL

Sotigalimab administered IV at 0.3 mg/kg every 3 weeks (21 day) treatment cycles

Drug: sotigalimab

Cohort 2

EXPERIMENTAL

Sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14 day) treatment cycles

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.

Drug: sotigalimab

Interventions

sotigalimab DRUG

Sotigalimab is a CD40 agonistic monoclonal antibody

Also known as: APX005M

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• a. For Cohort 3 only, subjects must have at least 3 measurable target lesions
• 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

You may not qualify if:

• 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)
• a. 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

Sponsors & Collaborators

• Apexigen America, Inc.: lead

Study Sites (19)

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

Poznan, Poland

Location

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

Warsaw, Poland

Location

Hospital Universitario San Juan De Alicante

Alicante, Spain

Location

Hospital Universitari Quirón Dexeus

Barcelona, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Location

Hospital Universitario Insular De Gran Canaria

Las Palmas de Gran Canaria, Spain

Location

Clínica Universidad De Navarra Sede Madrid

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Madrid Sanchinarro

Madrid, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Spain

Location

Hospital Clínico Universitario Virgen De La Arrixaca

Murcia, Spain

Location

Hospital Universitario De Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Universitario Marqués De Valdecilla

Santander, Spain

Location

Consorcio Hospital General Universitario de Valenc

Valencia, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Spain

Location

Instituto Valenciano de Oncología

Valencia, Spain

Location

Complexo Hospitalario Universitario De Vigo Álvaro Cunqueiro

Vigo, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

Melanoma; Neoplasms; Skin Neoplasms

Interventions

sotigalimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pyxis Oncology Clinical Operations
• Organization: Pyxis Oncology, Inc.

clinicaltrials@pyxisoncology.com

(339) 545 8252

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 8, 2020
• Study Start: June 12, 2019
• Primary Completion: July 29, 2022
• Study Completion: August 2, 2022
• Last Updated: February 13, 2024
• Results First Posted: December 22, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17); PL (2)