A Study to Evaluate the Safety and efficacy of the CD40 Agonistic Antibody APX005M in Adults with Immunotherapy Naive Metastatic Melanoma

Apexigen, Inc.0 sites36 target enrollmentJanuary 18, 2019

Conditionsnresectable or metastatic melanoma MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: nresectable or metastatic melanoma
Sponsor: Apexigen, Inc.
Enrollment: 36
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 18, 2019

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Apexigen, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Histologically or cytologically confirmed unresectable or metastatic melanoma
•2\. Subjects with BRAF activating mutation could 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
•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 of first dose of investigational product:
•a. WBC \=2 x 109/L in absence of growth factor support
•b. ANC \=1\.0 x 109/L in absence of growth factor support

Exclusion Criteria

•1\. Previous exposure to any immunomodulatory agent (such as CTLA\-4, PD\-1/PD\-L1, IDO inhibitors, interferon, etc.)
•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 product
•4\. Use of systemic corticosteroids or other systemic immunosuppressive drugs within the 28 days prior to first dose of investigational product (except inhaled corticosteroids)
•a. the use of physiologic doses of corticosteroids may beapproved after consultation with the Apexigen Medical Monitor (or designee)
•5\. Major surgery within 4 weeks of first dose of investigational product
•6\. Concurrent treatment with any anticancer agent, except for hormonal therapy and palliative radiation as clinically indicated unless approved by the Apexigen Medical Monitor (or designee)
•7\. History of allogeneic bone marrow transplantation
•8\. Active, known or suspected autoimmune disease
•9\. 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 I 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