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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose Escalation: Incidence of Adverse Events

Primary Outcome 1 - Timeframe: 1 years

Primary Outcome 2 - Measure: Dose Escalation: Incidence of Laboratory abnormalities

Primary Outcome 2 - Timeframe: 1 years

Primary Outcome 3 - Measure: Dose Escalation: Incidence of dose-limiting toxicity (DLT)

Primary Outcome 3 - Timeframe: 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 - Timeframe: 2 years

CONDITION

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

ELIGIBILITY

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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Shivaani Kummar, MD

Role: Principal Investigator

Affiliation: Oregon Health and Science University

Overall Contact

Name: Shivaani Kummar, MD

Phone: +82316280150

Email: GNC_Clinical@genomecom.co.kr

LOCATION