gen-001 (live biotherapeutic product) and avelumab combination study for patients with solid tumors who have progressed on anti-pd-(l)1 therapy

Conditions: Solid Tumor; Non Small Cell Lung Cancer; Squamous Cell Carcinoma of Head and Neck; Urothelial Carcinoma

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.


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.