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 Information
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
Administrative Informations
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