A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

Summary

This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.

Eligibility

Key Inclusion Criteria:

* Individuals ≥18 years of age.
* Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
* Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate organ function
* Adequate cardiac function
* Recovered from all AEs due to previous therapies to Grade ≤1 or baseline.
* Agreement to use highly effective contraception

Key Exclusion Criteria:

* Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1,
* Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1
* Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.
* History of treatment with direct and specific KRAS G12D inhibitors.
* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
* Inability to swallow oral medications.
* Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease
* Individuals who are pregnant or breastfeeding.

Conditions7

Interventions5

Locations13 sites

Find trials near these locations

Related trials

• A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer — Tianjin Medical University Cancer Institute and Hospital
• A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers — Hummingbird Bioscience
• A Study of BND-35 in Participants With Advanced Solid Tumors — Biond Biologics
• A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer — Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• AK129 Combination Therapy for Advanced Solid Tumors — Akeso
• ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors — Hansoh BioMedical R&D Company
• BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment — Pierre Fabre Pharma GmbH
• Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study — Sun Yat-sen University

Browse More Trials