← Back to searchRecruitingRecruiting
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
NCT05669430 · GV20 Therapeutics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor Malignancies
About this study
This is a Phase 1/2A non-randomized, open label, multi-center study to be conducted in four parts (Parts A, B, C and D).
In Part A, 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).
In Part B, 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 across multiple expansion cohorts involving eligible participants.
In Part C, 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 Part D, 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 across multiple expansion cohorts involving eligible participants.
Eligibility criteria
Inclusion Criteria:
* Participants ≥18 years of age
* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy
* Refractory or intolerant to standard therapy(ies)
* Must have received, be not eligible or decline standard of care therapy
* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
* ECOG performance status of 0 or 1
* Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D
* Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment (Parts A, B, C and D) and on-treatment (Parts A and B), if clinically feasible
* Disease-free of active second/secondary or prior malignancies for ≥ 2 years
* Laboratory test results within the required parameters
* Women of child bearing potential (WOCBP) and men must agree to use adequate contraception
* Parts B, C and D may include the following tumor types:
* Endometrial carcinoma
* Squamous head and neck carcinoma
* Cutaneous melanoma
* Non-small cell lung cancer
* Proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum (Parts C and D only)
Parts A, B, C and D Exclusion Criteria:
* Participant with acute leukemia or CLL (Parts A and B only)
* Participant with heart disease or unstable arrhythmia
* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
* History of major organ transplant
* History of a bone marrow transplant
* Symptomatic central nervous system (CNS) malignancy or metastasis
* Serious nonmalignant disease
* Pregnant or nursing women
* Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication
* Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication
* Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication
* Radiation for symptomatic lesions must have been completed prior to the first dose of study medication
* Participants with liver metastases unless approved by the Sponsor
* Any history of an immune related ≥ Grade 3 AE attributed to prior cancer immunotherapy
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1
* Has received radiation therapy to the lung that is higher than 30 Gy within 6 months prior to C1D1 for NSCLC (Parts C and D only)
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1 (Parts C and D only)
* Has severe hypersensitivity ( ≥ Grade 3) to Pembrolizumab and/or any of its excipients (Parts C and D only)
* Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease (Parts C and D only)
* Has a condition, therapy, laboratory abnormality, or circumstance that could confound study results or interfere with full participation, making it unsuitable for the participant, as determined by the treating Investigator (Parts C and D only)
* Active substance abuse
Study design
Enrollment target: 365 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-03-23
Estimated completion: 2027-09-05
Last updated: 2025-02-13
Interventions
Biological: GV20-0251Biological: GV20-0251Biological: GV20-0251 and Pembrolizumab [KEYTRUDA®]Biological: GV20-0251 and Pembrolizumab [KEYTRUDA®]
Primary outcomes
- • Objective Response Rate ORR per RECIST version 1.1 (Parts B and D) (12 months)
- • Percentage of Participants With Adverse Events (Parts A and C) (12 months)
Sponsor
GV20 Therapeutics · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactGV20 Therapeutics · contact · clinicaltrials@gv20tx.com · 617-256-2846
All locations (13)
The Angeles Clinic and Research InstituteRecruiting
Los Angeles, California, United States
HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONENot Yet Recruiting
Denver, Colorado, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute, LLCNot Yet Recruiting
Fort Myers, Florida, United States
Community Health Network, Inc.Recruiting
Indianapolis, Indiana, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer CenterRecruiting
Detroit, Michigan, United States
NYU Langone HealthRecruiting
New York, New York, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
Verdi Oncology Tennessee, Scri Oncology PartnersNot Yet Recruiting
Nashville, Tennessee, United States
Oncology Consultants, P.A.Recruiting
Houston, Texas, United States
The University of Texas M. D. Anderson Cancer CenterRecruiting
Houston, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States