OncoMatch/Clinical Trials/NCT06873763
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
Is NCT06873763 recruiting? Yes, currently enrolling (May 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
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
metastatic/recurrent colorectal cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
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.
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