Clinical Trials /

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

NCT04601402

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: [GNC] GEN001-101
  • NCT ID: NCT04601402

Conditions

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

Interventions

DrugSynonymsArms
GEN-001GEN-001 with avelumab
AvelumabBavencioGEN-001 with avelumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
GEN-001 with avelumabExperimentalDose 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.
  • GEN-001
  • Avelumab

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Escalation: Incidence of Adverse Events
Time Frame:1 years
Safety Issue:
Description:Assessed as per CTCAE v5.0

Secondary Outcome Measures

Measure:Objective Response (OR)
Time Frame:1 years
Safety Issue:
Description:Assessed according to RECIST v1.1
Measure:Duration of response (DoR)
Time Frame:up to 2 years
Safety Issue:
Description:Assessed according to RECIST v1.1
Measure:Progression-free survival (PFS)
Time Frame:up to 2 years
Safety Issue:
Description:Assessed according to RECIST v1.1
Measure:Overall Survival (OS)
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events
Time Frame:up to 2 years
Safety Issue:
Description:Assessed as per CTCAE v5.0
Measure:Incidence of Laboratory Abnormalities
Time Frame:up to 2 years
Safety Issue:
Description:Assessed as per CTCAE v5.0
Measure:irOR (Immune-related Objective Response)
Time Frame:up to 2 years
Safety Issue:
Description:Assessed according to irRECIST

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genome & Company

Last Updated

October 19, 2020