OncoMatch/Clinical Trials/NCT06873763
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
Is NCT06873763 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab for metastatic colorectal cancer (crc).
Treatment: Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab — The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
metastatic/recurrent colorectal cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: oxaliplatin-based chemotherapy
after failure of, or not eligible for oxaliplatin and irinotecan-based standard anticancer therapy
Must have received: irinotecan-based chemotherapy
after failure of, or not eligible for oxaliplatin and irinotecan-based standard anticancer therapy
Cannot have received: cytotoxic chemotherapy
Exception: cytotoxic chemotherapy within 14 days prior to randomization
Individuals who had cytotoxic chemotherapy within 14 days prior to randomization
Cannot have received: monoclonal antibody therapy
Exception: monoclonal antibody therapy within the past 4 weeks
treatment with monoclonal antibody therapy within the past 4 weeks
Cannot have received: trifluridine/tipiracil (trifluridine/tipiracil)
Exception: confirmed PD during treatment for palliative care or confirmed recurrence within 6 months after the end of such treatment
Confirmed PD during treatment with trifluridine/tipiracil for palliative care or confirmed recurrence within 6 months after the end of such treatment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Hemoglobin count (Hgb) ≥ 9.0 g/dL; Platelet count ≥ 100 x 10^9/L
Kidney function
Serum creatinine ≤ ULN x 1.5 or serum creatinine clearance > 30mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (Subjects with biliary obstruction may be enrolled if they meet the criterion after adequate biliary drainage); AST and ALT ≤ 3 x ULN in the absence of liver metastasis; or AST and ALT ≤ 5 x ULN in the presence of liver metastasis
Cardiac function
QTc calculated using the Fredericia formula ≤ 480 msec (Those with QTc >480 msec may be enrolled if the mean of 3 consecutive QTc measurements is <480 msec); adequate cardiac function at the screening visit
Subjects with adequate bone marrow and body organ functions * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Hemoglobin count (Hgb) ≥ 9.0 g/dL * Platelet count ≥ 100 x 109/L * Serum creatinine ≤ ULN x 1.5 or serum creatinine clearance > 30mL/min * Total bilirubin ≤ 1.5 x ULN (Subjects with biliary obstruction may be enrolled if they meet the criterion after adequate biliary drainage.) * AST and ALT ≤ 3 x ULN in the absence of liver metastasis; or AST and ALT ≤ 5 x ULN in the presence of liver metastasis Subjects with adequate cardiac function at the screening visit * QTc calculated using the Fredericia formula ≤ 480 msec (Those with QTc >480 msec may be enrolled if the mean of 3 consecutive QTc measurements is <480 msec.)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06873763 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytotoxic chemotherapy, monoclonal antibody therapy, trifluridine/tipiracil disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages