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

NCT04601402

CompletedPhase 1

Sponsor: Genome & Company

Conditions: Solid Tumor, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma

Interventions: GEN-001, Avelumab

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (3)

New Haven, Connecticut, United States
Atlanta, Georgia, United States
Portland, Oregon, United States