Primary Outcomes:

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

Condition:

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

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No