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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGEN-001 and Avelumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 8, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Genome & Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Genome & Company
Interventions being studied: Drug: GEN-001; Drug: Avelumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Yale Cancer CenterNew Haven, Connecticut
Emory University Winship Cancer InstituteAtlanta, Georgia
Oregon Health & Science UniversityPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 8, 2023. Always confirm current availability with the study team.

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