For Healthcare Professionals

A Study of GV20-0251 in Patients With Solid Tumor Malignancies

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. >= 18 years of age
  2. Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy
  3. Refractory or intolerant to standard therapy(ies)
  4. Must have received, be not eligible or decline standard of care therapy
  5. One or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1
  6. For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
  7. ECOG performance status of 0 or 1
  8. Life expectancy of >=12 weeks
  9. Disease-free of active second/secondary or prior malignancies for ≥ 2 years
  10. Laboratory test results within the required parameters
  11. Women of child bearing potential (WOCBP) and men must agree to use adequate contraception
  12. Part B ONLY must include the following tumor types:
  1. Cohort B1: bladder urothelial carcinoma
  2. Cohort B2: cholangiocarcinoma
  3. Cohort B3: proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum
  4. Cohort B4: proficient MMR (pMMR)/MSS endometrial carcinoma
  5. Cohort B5: deficient MMR (dMMR)/MSI-H endometrial carcinoma
  6. Cohort B6: squamous head and neck carcinoma
  7. Cohort B7: cutaneous melanoma
  8. Cohort B8: non-small cell lung cancer

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Participant with acute luekemia or CLL
  2. Participant with heart disease or unstable arrhythmia
  3. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
  4. Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
  5. Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
  6. History of major organ transplant
  7. History of a bone marrow transplant
  8. Symptomatic central nervous system (CNS) malignancy or metastasis
  9. Serious nonmalignant disease
  10. Pregnant or nursing women
  11. Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication
  12. 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
  13. Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication
  14. Radiation for symptomatic lesions must have been completed prior to the first dose of study medication
  15. Active substance abuse
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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.
Phone iconCall 617-256-2846Email iconEmail Study Center

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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