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

Brief Title

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

Official Title

A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Dose Escalation: Incidence of Adverse Events

Secondary Outcome

 Objective Response (OR)

Condition

Solid Tumor

Intervention

GEN-001

Study Arms / Comparison Groups

 GEN-001 with avelumab

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

93

Start Date

October 26, 2020

Completion Date

January 2024

Primary Completion Date

January 2024

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shivaani Kummar, MD, +82316280150, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04601402

Organization ID

[GNC] GEN001-101

Responsible Party

Sponsor

Study Sponsor

Genome & Company

Collaborators

 Merck KGaA, Darmstadt, Germany

Study Sponsor

Shivaani Kummar, MD, Principal Investigator, Oregon Health and Science University

Verification Date

February 2021