A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

Summary

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer

Eligibility

Inclusion Criteria:

* Histopathology confirmed metastatic CRC
* Measurable disease per RECIST 1.1
* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
* ECOG PS=0 or 1

  2L+ patients:
* Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
* Have documented disease progression during or following their most recent prior line of therapy
* Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.

  1L patients:
* Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.

Exclusion Criteria:

* Have any other documented co-existing common RAS mutation(s)
* Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
* Major surgery within 4 weeks of first treatment dose
* Radiation therapy (RT) within 1 week of first treatment dose
* Receipt of prior direct RAS inhibitor
* Receipt of more than 1 investigational therapy
* Untreated or symptomatic CNS metastasis
* Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
* Receipt of PPI or H2 blocker within 5 days
* Inability to swallow oral medication
* Other protocol-defined inclusion/exclusion criteria may apply

Conditions2

Interventions4

Locations13 sites

Find trials near these locations

Related trials

• A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations — BeOne Medicines
• A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer — Multitude Therapeutics Inc.
• 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 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

Browse More Trials