A Study of GV20-0251 in Patients With Solid Tumor Malignancies
About the study
This is a Phase 1 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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- >= 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
- One or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1
- 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
- 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
- Part B ONLY must include the following tumor types:
- Cohort B1: bladder urothelial carcinoma
- Cohort B2: cholangiocarcinoma
- Cohort B3: proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum
- Cohort B4: proficient MMR (pMMR)/MSS endometrial carcinoma
- Cohort B5: deficient MMR (dMMR)/MSI-H endometrial carcinoma
- Cohort B6: squamous head and neck carcinoma
- Cohort B7: cutaneous melanoma
- Cohort B8: non-small cell lung cancer
EXCLUSION CRITERIA
Exclusion Criteria:
- Participant with acute luekemia or CLL
- 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
- Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
- 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
- Active substance abuse
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Solid Tumor, Adult,Refractory Cancer,Bladder Urothelial Carcinoma,Cholangiocarcinoma,Adenocarcinoma of the Colon,Endometrial Carcinoma,Head and Neck Carcinoma,Cutaneous Melanoma,Non-small Cell Lung Cancer,Adenocarcinoma of the Rectum
Age
18+
Phase
PHASE1
Participants Needed
268
Est. Completion Date
Jun 15, 2026
Treatment Type
INTERVENTIONAL
Sponsor
GV20 Therapeutics
ClinicalTrials.gov NCT Identifier
NCT05669430
Study Number
GV20-0251-100
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