XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorecta… (NCT06936527) | Clinical Trial Compass
By InvitationPhase 1/2
XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation
China102 participantsStarted 2025-05-23
Plain-language summary
XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab for treatment of metastatic colorectal cancer patients with RAS mutation
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in the clinical trial and sign the informed consent form.
✓. Age ≥18 and ≤ 70 years. No gender restrictions.
✓. Patients with histologically and/or cytologically confirmed metastatic colorectal cancer who are not suitable for surgical treatment.
✓. Advanced or metastatic colorectal cancer: Stage Ib patients must have received at least one prior systemic therapy; Stage II patients have no prior systemic therapy. For patients with previously neoadjuvant/adjuvant therapy, disease progression must occur no less than 6 months after the end of therapy to be eligible for inclusion.
✓. Documentation of RAS mutation. The previously gene test report issued by qualified testing institution is acceptable. BRAF status is not restricted.
✓. Consent to provide tumor tissue samples and peripheral blood for biomarker analysis.
✓. Has measurable extracranial lesion according to RECIST v1.1 criteria, defined as at least one lesion that has not received radiotherapy. For previously radiotherapy lesion, there must be imaging evidence of progression after radiotherapy.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
Exclusion criteria
✕. Patients with known high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) primary or metastatic colorectal cancer and suitable for immune checkpoint inhibitor treatment assessed by investigators.
✕
What they're measuring
1
Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab
Timeframe: up to day 28
2
Phase 1b: Determine the Maximum Tolerated Dose (MTD) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab
Timeframe: up to day 28
3
Phase 2: Objective Response Rate (ORR) of two experimental arms and comparator arm
Timeframe: up to 18 months after first dose of last patient
. Previously received bevacizumab and its biosimilar therapy. (Only for phase II)
✕. Central nervous system metastases which are symptomatic or require therapy.
✕. Imaging shows major blood vessel invasion (such as the aorta, pulmonary artery, pulmonary vein, vena cava, etc.).
✕. Adverse events and/or complications that caused by previous antitumor therapy have not recovered to baseline level or ≤ CTCAE grade 1.
✕. With a history of other malignancies within 5 years or with other malignancies currently prior to screening, except colorectal cancer. Exception: curatively treated early-stage malignancies (in situ carcinoma or stage I tumors), such as adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix.
✕. Patients have a significant risk of bleeding.
✕. Patients have a significant risk of thrombus.