GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
18 Years and older, Male and Female
[GNC] GEN001-101 (primary)
NCI-2020-09143
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
- 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)
Treatment Sites in Georgia
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