Actively Recruiting
A Single-arm Phase Ib/II Study of Nelmastobart with Trifluridine/Tipiracil and Bevacizumab in Metastatic/Recurrent Colorectal Cancer Resistant or Intolerant to Oxaliplatin and Irinotecan Chemotherapy
Led by STCube, Inc. · Updated on 2025-07-11
52
Participants Needed
5
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying metastatic or recurrent colorectal cancer patients who have resistance or intolerance to standard chemotherapy based on oxaliplatin and irinotecan. This multi-center, open-label Phase Ib/II trial evaluates the safety, how the body processes, and the effectiveness of nelmastobart combined with trifluridine/tipiracil and bevacizumab. The study also aims to find the maximum tolerated dose and recommended dose for further study, especially in patients positive for BTN1A1. Participants receive nelmastobart together with fixed doses of bevacizumab and varying doses of trifluridine/tipiracil, which will be reduced in steps from 35 mg/m² to 25 mg/m² to determine the best dose. The study includes a single treatment group and looks at dose-limiting toxicities over up to 6 months, with longer-term follow-up for up to 2 years on progression-free survival and other outcomes. During the study, patients will be monitored for side effects and treatment effects using scans, blood tests, and clinical evaluations. Researchers will measure how long the cancer remains stable, survival rates, response rates, and drug levels in the blood. Safety and tolerability will be assessed throughout the treatment and follow-up periods, which may last up to 2 years after starting therapy.
CONDITIONS
Brief Title
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 19 years or older
- Histologically or cytologically confirmed metastatic or recurrent colorectal cancer after failure of or not eligible for oxaliplatin and irinotecan-based therapy
- At least one evaluable or measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Adequate bone marrow and organ function including ANC ≥ 1.5 x 10^9/L, hemoglobin ≥ 9.0 g/dL, platelets ≥ 100 x 10^9/L, serum creatinine ≤ 1.5 times ULN or clearance > 30 mL/min, bilirubin ≤ 1.5 times ULN, AST and ALT ≤ 3 times ULN without liver metastasis or ≤ 5 times ULN with liver metastasis
- Adequate cardiac function with QTc ≤ 480 msec
- Negative serum β-HCG test for women of childbearing potential within 14 days before dosing
- Agreement to use medically reliable contraception during and for 6 months after treatment
- Life expectancy of at least 3 months
- Consent to tumor tissue sampling or use of recent tumor samples
- For phase 2: Tumor Proportion Score (TPS) ≥ 50 based on immunohistochemistry
You will not qualify if you...
- Hypersensitivity to study drug or components
- Cytotoxic chemotherapy within 14 days prior to randomization or monoclonal antibody therapy within 4 weeks
- Uncontrolled serious infection
- Disease progression during prior trifluridine/tipiracil treatment or recurrence within 6 months after
- Use of high-dose steroids or immunosuppressants except for limited allowed cases
- Pregnant or breastfeeding women
- Autoimmune diseases requiring systemic treatment within 2 years, except certain stable conditions
- Active or unstable central nervous system lesions
- Recent cardiovascular events or unstable heart conditions
- Uncontrolled hypertension
- History of certain lung diseases or active pneumonia
- Prior stem cell or organ transplants
- Recent live attenuated vaccines
- History of other primary cancers except specific treated types
- Unrecovered side effects from prior therapy except alopecia
- Recent extensive radiotherapy or major surgery
- Inability to take oral drugs or major gastrointestinal surgery affecting absorption
- Active infection with hepatitis B, C, or HIV unless viral DNA or RNA is negative
- Hereditary metabolic disorders affecting drug metabolism
- Medical, psychiatric, or cognitive disorders affecting consent or study compliance
- Investigator judgment deeming participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive Nelmastobart in combination with Trifluridine/Tipiracil and Bevacizumab with dose adjustments to determine the recommended phase 2 dose.
Visits occur regularly during treatment for dosing and monitoring
Trial Site Locations
Total: 5 locations
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Not Yet Recruiting
2
Seoul National University Hospital
Seoul, KR, South Korea, 03080
Not Yet Recruiting
3
Severance Hospital
Seoul, KR, South Korea, 03722
Not Yet Recruiting
4
Asan Medical Center
Seoul, KR, South Korea, 05505
Not Yet Recruiting
5
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
Research Team
H
Hyunju Yoo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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