GV20-0251 treatment for advanced solid tumors
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
This study is testing a new treatment called GV20-0251 for people with advanced solid tumors that haven't improved with standard treatments, to see how safe it is and if it works better when combined with another medication.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 365 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GV20 Therapeutics Industry-sponsored |
| Drugs / interventions | Pembrolizumab, immunotherapy, Radiation |
| Locations | 13 sites (Los Angeles, California and 12 other locations) |
| Trial ID | NCT05669430 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2A study evaluates GV20-0251, a novel treatment for patients with advanced solid tumors that have not responded to standard therapies. The study is structured in four parts, including dose escalation to determine safety and tolerability, and further assessment of anti-tumor activity in combination with Pembrolizumab. Participants will undergo a series of evaluations to establish the maximum tolerated dose and the pharmacokinetics of the treatment. The study aims to provide insights into the effectiveness of GV20-0251 both alone and in combination with an established immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced solid malignancies that are refractory to standard therapies.
Not a fit: Patients with active second malignancies or those who have not progressed after prior checkpoint inhibitor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with refractory solid tumors.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being explored for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 12 other locations
- The Angeles Clinic and Research Institute — Los Angeles, California, United States (Recruiting)
- HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (Not_yet_recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Florida Cancer Specialists & Research Institute, LLC — Fort Myers, Florida, United States (Not_yet_recruiting)
- Community Health Network, Inc. — Indianapolis, Indiana, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center — Detroit, Michigan, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Verdi Oncology Tennessee, Scri Oncology Partners — Nashville, Tennessee, United States (Not_yet_recruiting)
- Oncology Consultants, P.A. — Houston, Texas, United States (Recruiting)
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: GV20 Therapeutics
- Email: clinicaltrials@gv20tx.com
- Phone: 617-256-2846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.