A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
NCT ID: NCT05669430
Last Updated: 2025-02-13
Study Results
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Basic Information
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RECRUITING
PHASE1/PHASE2
365 participants
INTERVENTIONAL
2023-03-23
2027-09-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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).
GV20-0251
Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.
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.
GV20-0251
GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.
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.
GV20-0251 and Pembrolizumab [KEYTRUDA®]
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.
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.
GV20-0251 and Pembrolizumab [KEYTRUDA®]
GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.
Interventions
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GV20-0251
Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.
GV20-0251
GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.
GV20-0251 and Pembrolizumab [KEYTRUDA®]
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®]
GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
GV20 Therapeutics
INDUSTRY
Responsible Party
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Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute, LLC
Fort Myers, Florida, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, United States
NYU Langone Health
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Verdi Oncology Tennessee, Scri Oncology Partners
Nashville, Tennessee, United States
Oncology Consultants, P.A.
Houston, Texas, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Li Y, Wu X, Sheng C, Liu H, Liu H, Tang Y, Liu C, Ding Q, Xie B, Xiao X, Zheng R, Yu Q, Guo Z, Ma J, Wang J, Gao J, Tian M, Wang W, Zhou J, Jiang L, Gu M, Shi S, Paull M, Yang G, Yang W, Landau S, Bao X, Hu X, Liu XS, Xiao T. IGSF8 is an innate immune checkpoint and cancer immunotherapy target. Cell. 2024 May 23;187(11):2703-2716.e23. doi: 10.1016/j.cell.2024.03.039. Epub 2024 Apr 23.
Wentzel, K., Peguero, J., Kummar, S., Lorusso, P., Mehnert, J. M., Spira, A. I., Naing, A., Hamid, O., Mehmi, I., Benhadji, K., Alland, L., Hu, X., Xiao, H., Bao, X., Chen, J., Gong, Y., Liu, X. S. ESMO 2024
Related Links
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IGSF8 is an innate immune checkpoint and cancer immunotherapy target
A phase I/II, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors
Other Identifiers
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GV20-0251-100
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-F77
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-F77
Identifier Type: OTHER
Identifier Source: secondary_id
GV20-0251-100
Identifier Type: -
Identifier Source: org_study_id
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