Study of GV20-0251 for Advanced Solid Tumors
This study is testing a new treatment called GV20-0251, either alone or combined with pembrolizumab (KEYTRUDA®), for adults with advanced solid tumors that have not responded to standard treatments. The study aims to find the safest and most effective dose of GV20-0251, and to see how well it shrinks tumors. Researchers will also look at side effects. You may be eligible if you have a solid tumor that has progressed despite previous treatments and you are at least 18 years old. Success will be measured by how many participants experience tumor shrinkage and by tracking any side effects over 12 months. The current recruitment status is unclear.
- Study design
- This is a Phase 1/2A, non-randomized, open-label study involving up to 365 participants. It will test GV20-0251 alone and in combination with pembrolizumab.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 months to assess tumor response and adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05669430
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatmentGV20 Therapeutics
~365 participants
Updated 2025-02-13 on ClinicalTrials.gov
What's tested:GV20-0251GV20-0251 and Pembrolizumab [KEYTRUDA®]
At a glance
Recruiting sites
10 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate ORR per RECIST version 1.1 (Parts B and D)
Measured over 12 months
+1 more outcome measured
Conditions
Where it's being run
13 sites across 12 statesTexas2
California1
Colorado1
Connecticut1
Florida1
Indiana1
Massachusetts1
Michigan1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
Exclusion
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
What this trial measures
- Objective Response Rate ORR per RECIST version 1.1 (Parts B and D)12 months
ORR
- Percentage of Participants With Adverse Events (Parts A and C)12 months