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Recruiting Phase 2 NCT06792695

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

Trial Parameters

Condition Metastatic Colorectal Cancer
Sponsor AstraZeneca
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age 130 Years
Start Date 2025-03-12
Completion 2027-05-31
Interventions
VolrustomigFOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)Bevacizumab

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

Eligibility Criteria

Overall Inclusion Criteria: * Histopathologically confirmed colorectal adenocarcinoma. * Provision of FFPE tumor sample collected as per SoC. * Presence of measurable disease by RECIST 1.1 criteria. * ECOG performance status of 0 or 1. * Life expectancy ≥ 12 weeks at the time of screening. Substudy Inclusion Criteria: * No radiological evidence of liver metastasis. * No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, \> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease. * Known pMMR/MSS status (only pMMR/MSS mCRC allowed). * Adequate organ and bone marrow function * Body weight \> 35 kg at screening and at randomization. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Overall Exclusion Criteria: * Central nervous system metastases or spinal cord compression * Known h

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