> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-gv20-0251-monotherapy-and-gv20-0251-in-170024b7-b556-4c63-b0b1-971c8d09b2da > Record changed: 2026-10-13 # A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies NCT05669430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) Participants 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) Lead sponsor GV20 Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) Start date 2023-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) Number of sites 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Short title** A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Dates **Completion date** 2027-09-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **First posted** 2022-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Registry last updated** 2025-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Primary completion date** 2026-12-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Start date** 2023-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Size and sites **Participants** 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Planned participants** 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Number of sites** 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Lead sponsor** GV20 Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Identifiers **Registry ID** NCT05669430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **ClinicalTrials.gov ID** NCT05669430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Outcomes ### Primary outcomes 1. Objective Response Rate ORR per RECIST version 1.1 (Parts B and D) Timeframe: 12 months ORR 2. Percentage of Participants With Adverse Events (Parts A and C) Timeframe: 12 months ### Secondary outcomes 1. Overall Survival (Parts B and D) Timeframe: 24 months OS 2. Additional safety and tolerability Timeframe: 24 months TEAEs per NCI CTCAE version 5.0 3. Cmax of GV20-0251 Timeframe: 12 months Maximum concentration 4. Tmax of GV20-0251 Timeframe: 12 months Time to peak drug concentration 5. T1/2 Timeframe: 12 months Terminal half-life of GV20-0251 6. AUC Timeframe: 12 months Area under the curve 7. ADAs Timeframe: 12 months Specification and quantification of anti-drug antibodies 8. nADAs Timeframe: 12 months Neutralizing anti-drug antibodies 9. DCR Timeframe: 24 months Disease Control Rate is the percentage of participants with stable disease, complete response or partial response among all response evaluable participants 10. DoR Timeframe: 24 months Duration of Response is the time from first CR/PR to the date of PD or death. 11. PFS Timeframe: 24 months Progression Free Survival is the duration from the first dose to PD/death 12. ORR (Parts A and C) Timeframe: 24 months Percentage of participants with complete response or partial response among all response evaluable participants Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Sites - The Angeles Clinic and Research InstituteLos Angeles, United StatesRecruiting - HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONEDenver, United StatesNot yet recruiting - Yale UniversityNew Haven, United StatesRecruiting - Florida Cancer Specialists & Research Institute, LLCFort Myers, United StatesNot yet recruiting - Community Health Network, Inc.Indianapolis, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer CenterDetroit, United StatesRecruiting - NYU Langone HealthNew York, United StatesRecruiting - Oregon Health & Science UniversityPortland, United StatesRecruiting - Verdi Oncology Tennessee, Scri Oncology PartnersNashville, United StatesNot yet recruiting - Oncology Consultants, P.A.Houston, United StatesRecruiting - The University of Texas M. D. Anderson Cancer CenterHouston, United StatesRecruiting - Virginia Cancer SpecialistsFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## References - PubMed 38657602 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38657602/) Background - Publication recorded without a publication identifierResults - Related resource (doi.org) Source: [doi.org](https://doi.org/10.1016/j.cell.2024.03.039) - Related resource (doi.org) Source: [doi.org](https://doi.org/10.1016/j.annonc.2024.08.1059) ### Other registry identifiers (2) - MK-3475-F77 - GV20-0251-100 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669430) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [GV20 Therapeutics](https://trialight.com/data/company/gv20-therapeutics-7b5ccb8a-9634-442a-91b6-ed7bdd215a0d.md) ### Conditions (8) - [ADULT syndrome](https://trialight.com/data/condition/adult-syndrome-8aeb5e11-f165-5276-850c-05129a3e72a5.md) Primary condition - [Cutaneous melanoma](https://trialight.com/data/condition/cutaneous-melanoma-c6e75b71-1c7c-59fe-a087-174eb0ec53df.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Endometrial carcinoma](https://trialight.com/data/condition/endometrial-carcinoma-d0794a04-ff16-5af6-8fb7-7b3d6bd6c537.md) - [Head and neck carcinoma](https://trialight.com/data/condition/head-and-neck-carcinoma-15d11e2c-18dd-5089-9c7b-487ae515e69c.md) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Refractory malignant neoplasm](https://trialight.com/data/condition/refractory-malignant-neoplasm-a7eab4b9-4068-5719-be3b-3c65d0c76fa1.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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