GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
NCT04601402
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
+82316280150
- 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)
- 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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Descriptive Information | |||||
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Brief Title ICMJE | GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: Dose Escalation: Seqeuntial Group Assignment, Dose Expansion: Parallel Group Assignment Masking: None (Open Label)Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: GEN-001 with avelumab
Dose Escalation Cohort includes patients with 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) will be enrolled. 3 or 6 patients will be enrolled per escalating or de-escalating dose levels. Dose Expansion Cohort includes patients with advanced or metastatic NSCLC, SCCHN, and UC 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)will be enrolled. Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 93 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | January 2024 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04601402 | ||||
Other Study ID Numbers ICMJE | [GNC] GEN001-101 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Genome & Company | ||||
Study Sponsor ICMJE | Genome & Company | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Genome & Company | ||||
Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |