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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | October 2020 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Dose Escalation: Incidence of Adverse Events
Primary Outcome 1 - Time Frame: 1 years
Primary Outcome 2 - Measure: Dose Escalation: Incidence of Laboratory abnormalities
Primary Outcome 2 - Time Frame: 1 years
Primary Outcome 3 - Measure: Dose Escalation: Incidence of dose-limiting toxicity (DLT)
Primary Outcome 3 - Time Frame: 1 Cycle (one cycle = 28 days)
Primary Outcome 4 - Measure: Dose Expansion: To assess objective response (OR) of GEN-001 in patients with advanced or metastatic solid tumors, when administered as combined with avelumab.
Primary Outcome 4 - Time Frame: 2 years
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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Shivaani Kummar, MD
Role: Principal Investigator
Affiliation: Oregon Health and Science University
Name: Clinical Development
Phone: +82316280150
Email: GNC_Clinical@genomecom.co.kr
Facility | Status | Contact |
---|---|---|
Yale Cancer Center New Haven, Connecticut 06510 United States |
Not yet recruiting | |
Emory University Winship Cancer Institute Atlanta, Georgia 30322 United States |
Not yet recruiting | |
Oregon Health & Science University Portland, Oregon 97239 United States |
Recruiting |