NCT05669430RecruitingPhase 1/2
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
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
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 365 (estimated)
- First submitted
- 12 Dec 2022
- Start date
- 23 Mar 2023
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- GV20 Therapeutics
- Diseases
- Melanoma, Endometrial cancer, Lung cancer, Colorectal cancer
- NCT number
- NCT05669430
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 365
- From 23 Mar 2023 to the primary completion date, 15 Dec 2026
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE Coordinator of this site? Confirm its status | Denver | United States | Not yet recruiting |
| Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Florida Cancer Specialists & Research Institute, LLC Coordinator of this site? Confirm its status | Fort Myers | United States | Not yet recruiting |
| The University of Texas M. D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Oncology Consultants, P.A. Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Community Health Network, Inc Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| The Angeles Clinic and Research Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Verdi Oncology Tennessee, Scri Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.