A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination with Nivolumab in Subjects with Non-small Cell Lung Cancer and Subjects with Metastatic Melanoma

Apexigen, Inc.0 sites174 target enrollmentJanuary 18, 2019

Conditionson-small Cell Lung Cancer and Metastatic Melanoma MedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOPDIVO 10 mg/mL concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on-small Cell Lung Cancer and Metastatic Melanoma
Sponsor: Apexigen, Inc.
Enrollment: 174
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

•Phase Specific Criteria
•Phase 1b: Subjects that meet eligibility criteria for Phase 2 Cohorts 1 or 2 and all of the general eligibility criteria
•Phase 2 Cohort 1 (inNSCLC): Histologically or cytologically confirmed, immunotherapy naïve, metastatic or locally advanced non\-small cell lung cancer not amenable to curative treatment. Subjects may be treatment naïve or could have received one prior platinum\-based chemotherapy for non\-small cell lung cancer for any indication (adjuvant, part of combined modality therapy or for metastatic disease) within the past 3 years. Subjects with no or unknown activating mutation (e.g., EGFR, ALK, ROS) are eligible for this study. Subjects with a documented activating mutation (e.g., EGFR, ALK, ROS) amenable to tyrosine kinase inhibitor therapy, must also have received the appropriate therapy and progressed.
•Phase 2 Cohort 2 (PD1\-MM): Subjects with histologically or cytologically confirmed unresectable or metastatic melanoma that had confirmed progressive disease during treatment with anti\-PD\-1/PD\-L1 therapy. Subjects with BRAF wild type or unknown status must have received only anti\-PD\-1/PD\-L1 therapy. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti\-PD\-1/PD\-L1 therapy. Subjects with ocular melanoma are excluded.
•Phase 2 Cohort 3 (PD1\-NSCLC): Subjects with histologically or cytologically confirmed, metastatic or locally advanced NSCLC not amenable to curative treatment. Subjects must have disease progression on an immediately preceding PD\-1/PD\-L1 containing regimen. Subjects could have received no more than one platinum containing regimen, or if subjects have a documented activating mutation (e.g. EGFR, ALK, ROS) amenable to tyrosine kinase inhibitor therapy, must also have received the appropriate therapy and progressed before the PD\-1/PD\-L1 containing regimen. Based on response to previous PD\-1/PD\-L1 containing regimen, subjects will be enrolled in one of the following groups:
•Group A: Subjects with best response of progressive disease or with stable disease \< 16 weeks
•Group B: Subjects with tumor response or with stable disease \= 16 weeks
•General Inclusion Criteria:
•1\.Subjects willing and able to provide written informed consent for this study
•2\.Male or female \=18 years old at time of consent

Exclusion Criteria

•General Exclusion Criteria:
•1\.Previous exposure to any immunomodulatory agents (e.g., anti\- CD40, CTLA\-4, PD\-1/ PD\-L1, IDO inhibitors) with the following exceptions:
•a.For Cohort 2 (unresectable or metastatic melanoma):
•i. All subjects must have confirmed disease progression while on treatment with anti\-PD\-1/PD\-L1 therapy
•ii.Subjects could have received anti\-CTLA\-4 therapy provided they did not have disease progression while on therapy and they discontinue treatment with anti\-CTLA\-4 therapy at least 3 months prior to first dose of investigational product
•b.For Cohort 3 (metastatic or locally advanced NSCLC):
•i.All subjects must have disease progression while on treatment with anti\-PD\-1/PD\-L1 therapy
•2\.Second malignancy (solid or hematologic) within the past 3 years except:
•a.Adequately treated basal cell or squamous cell skin cancer, or
•b.Carcinoma in situ of the cervix, or