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New treatment option for Solid Tumor, Adult
Official title A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT05669430
What this study is testing
What is GV20-0251?
GV20-0251 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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...
- Active substance abuse
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Fort Myers, Florida, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Fort Myers, Florida, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.