GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

NCT ID: NCT04601402

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2023-01-11

Brief Summary

This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.

Conditions

Solid Tumor; Non Small Cell Lung Cancer; Squamous Cell Carcinoma of Head and Neck; Urothelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GEN-001 with avelumab

Dose Escalation Cohort includes patients with advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination) will be enrolled. 3 or 6 patients will be enrolled per escalating or de-escalating dose levels.

Dose Expansion Cohort includes patients with advanced or metastatic NSCLC, SCCHN, and UC who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)will be enrolled.

Group Type: EXPERIMENTAL

GEN-001

Intervention Type: DRUG

The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10\^11 colony-forming units (CFU)

Avelumab

Intervention Type: DRUG

800 mg given by intravenous (IV) infusion once every 2 weeks

Interventions

GEN-001

The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10\^11 colony-forming units (CFU)

Intervention Type: DRUG

Avelumab

800 mg given by intravenous (IV) infusion once every 2 weeks

Intervention Type: DRUG

Other Intervention Names

Bavencio

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have adequate organ functions as defined in the protocol
• Negative childbearing potential
• Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities
• Patients with diseases for which no curative therapies are available, and who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)
• Disease progression on anti-PD-(L)1 based therapy (as monotherapy or combination therapy) and must meet criteria for acquired resistance as defined in the protocol
• Patients who have completely recovered from any clinically significant AEs that occurred during prior immunotherapy
• Estimated life expectancy of at least 3 months
• Objective evidence of disease progression at baseline (Dose Escalation)
• Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic NSCLC, SCCHN, and UC (Dose Expansion)
• Measurable disease as per RECIST v1.1 defined as at least 1 lesion (Dose Expansion)

Exclusion Criteria

• Have experienced primary resistance to anti-PD-(L)1 based therapy
• Has experienced a toxicity that led to permanent discontinuation of prior anti-PD-(L)1 based therapy or other immunotherapies
• Has active autoimmune disease that has required systemic treatment in the past 2 years
• Current use of immunosuppressive medication at time of study entry
• Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within the previous 4 weeks of starting study treatment
• Has received a live vaccine within 4 weeks of starting of study treatment
• Known history of, or any evidence of active, non-infectious pneumonitis
• Prior solid organ or allogeneic stem cell transplantation
• Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks of starting study treatment
• Has received proton pump inhibitors (PPIs) within 2 weeks prior to dosing study treatments
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has clinically significant (i.e., active) cardiovascular disease
• Has known history of uncontrolled intercurrent illness
• Has any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Genome & Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shivaani Kummar, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Yale Cancer Center

New Haven, Connecticut, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

[GNC] GEN001-101

Identifier Type: -

Identifier Source: org_study_id