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BRIEF TITLE: Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy

A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy


  • Org Study ID: [GNC] GEN001-101
  • Secondary ID:
  • NCT ID: NCT04601402
  • NCT Alias:
  • Sponsor: Genome & Company - Industry
  • Source: Genome & Company

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting October 2020 Phase 1 Interventional

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

Official Information

Name: Shivaani Kummar, MD

Role: Principal Investigator

Affiliation: Oregon Health and Science University

Overall Contact

Name: Clinical Development

Phone: +82316280150

Email: GNC_Clinical@genomecom.co.kr

Locations

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