RecruitingPhase 1Phase 2NCT05669430
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
Sponsor
GV20 Therapeutics
Enrollment
365 participants
Start Date
Mar 23, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria18
- 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)
Exclusion Criteria22
- 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
Interventions
BIOLOGICALGV20-0251
Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.
BIOLOGICALGV20-0251
GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.
BIOLOGICALGV20-0251 and Pembrolizumab [KEYTRUDA®]
GV20-0251 administered by IV infusion at 10 mg/kg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.
BIOLOGICALGV20-0251 and Pembrolizumab [KEYTRUDA®]
GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05669430
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