Actively Recruiting
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
Led by STCube, Inc. · Updated on 2025-07-11
52
Participants Needed
5
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 at the time of consent
- Histologically or cytologically confirmed metastatic or recurrent colorectal cancer after failure of or ineligibility for oxaliplatin and irinotecan-based therapy
- At least one evaluable or non-measurable but evaluable 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 ≤ ULN x 1.5 or creatinine clearance > 30 mL/min, total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN without liver metastasis or ≤ 5 x ULN with liver metastasis
- Adequate cardiac function with QTc ≤ 480 msec (mean of 3 measurements if initial >480)
- Negative serum β-HCG test for women of childbearing potential within 14 days before dosing
- Agreement and ability to use medically reliable contraception methods during the study
- Life expectancy of at least 3 months
- Consent to tumor tissue sampling or provide tumor tissue samples obtained within 2 years prior to screening
- Voluntary written informed consent and agreement to comply with study procedures
- For phase 2: Tumor Proportion Score of 50 or higher based on immunohistochemistry at screening
You will not qualify if you...
- Hypersensitivity to study drugs or components
- Cytotoxic chemotherapy within 14 days before randomization or monoclonal antibody therapy within 4 weeks
- Uncontrolled serious infection
- Disease progression during trifluridine/tipiracil treatment or recurrence within 6 months after treatment
- Use of high-dose steroids (>10 mg/day prednisone or equivalent) or immunosuppressants except allowed short-term or replacement therapies
- Pregnant or lactating women
- History of autoimmune disease requiring systemic treatment within 2 years except certain stable conditions
- Active central nervous system lesions unless stable without steroids for at least 4 weeks
- Recent serious cardiovascular events within 6 months
- Uncontrolled hypertension or hypertensive encephalopathy
- History or active pulmonary disease including pneumonitis or pneumonia
- Prior allogeneic stem cell or solid organ transplant
- Live attenuated vaccine within 30 days before screening
- History of other primary cancers except certain treated and stable cancers
- Unrecovered side effects from prior cancer therapy except alopecia
- Recent radiotherapy or major surgery within specified time frames
- Inability to take oral drugs or major gastrointestinal surgery affecting absorption
- Active infections including hepatitis B, C, or HIV unless controlled
- Hereditary problems like galactose intolerance or lactase deficiency
- Medical, psychiatric, or cognitive disorders impairing consent or compliance
- Investigator judgment deeming participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here