A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
GV20 Therapeutics
Study ID
NCT05669430
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cutaneous Melanoma
  • Endometrial Carcinoma (EC)
  • Non-Small Cell Lung Cancer
  • Refractory Cancer
  • Solid Tumor, Adult
  • Squamous Head and Neck Carcinoma
  • pMMR/MSS Adenocarcinoma of the Colon or Rectum

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GV20-0251 — BIOLOGICAL
    Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.
  • GV20-0251 — BIOLOGICAL
    GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.
  • GV20-0251 and Pembrolizumab [KEYTRUDA®] — BIOLOGICAL
    GV20-0251 administered by IV infusion at 10 mg/kg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.
  • GV20-0251 and Pembrolizumab [KEYTRUDA®] — BIOLOGICAL
    GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

Study Details

This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.

Key Dates

Start date
Mar 23, 2023
Status verified
Feb 2025
Primary completion
Dec 15, 2026
Completion
Sep 5, 2027

Study Design

Enrollment
365 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - Dose Escalation in up to 7 dose levels
    A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).
  • Experimental: Part B - Multiple Expansion Cohorts in up to 4 tumor indications
    The Bayesian optimal design for Phase II (BOP2) will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D in up to 4 expansion cohorts involving eligible participants.
  • Experimental: Part C - GV20-0251 in Combination with Pembrolizumab Dose Escalation in 2-4 dose levels
    The Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination in selected tumor indications.
  • Experimental: Part D - GV20-0251 in Combination with Pembrolizumab Dose Expansion in up to 5 indications
    The BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with pembrolizumab at the preliminary RP2D in up to 5 expansion cohorts involving eligible participants.

Primary Outcome Measure

Objective Response Rate ORR per RECIST version 1.1 (Parts B and D) [ Time Frame: 12 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025
GV20 Therapeutics
[email protected]
Kristopher Wentzel, MD (PRINCIPAL_INVESTIGATOR)
HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONEDenverColorado80218
GV20 Therapeutics
[email protected]
Jason Henry, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06511
GV20 Therapeutics
[email protected]
Patricia LoRusso, DO (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists & Research Institute, LLCFort MyersFlorida33916
GV20 Therapeutics
[email protected]
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
Community Health Network, Inc.IndianapolisIndiana46256
GV20 Therapeutics
[email protected]
Bert O'Neil, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
GV20 Therapeutics
[email protected]
Justin Gainor, MD (PRINCIPAL_INVESTIGATOR)
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer CenterDetroitMichigan48201
GV20 Therapeutics
[email protected]
M. Najeeb Al Hallak, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
GV20 Therapeutics
[email protected]
Janice Mehnert, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
GV20 Therapeutics
[email protected]
Shivaani Kummar, MD (PRINCIPAL_INVESTIGATOR)
Verdi Oncology Tennessee, Scri Oncology PartnersNashvilleTennessee37203
GV20 Therapeutics
[email protected]
Meredith Pelster, MD (PRINCIPAL_INVESTIGATOR)
Oncology Consultants, P.A.HoustonTexas77030
GV20 Therapeutics
[email protected]
Jose Peguero, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
GV20 Therapeutics
[email protected]
Aung Naing, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
GV20 Therapeutics
[email protected]
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

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