Nelmastobart in Combination With Tas-102 and Bevacizumab in Recurrent/Metastatic Colorectal Cancer (NCT07656038) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Nelmastobart in Combination With Tas-102 and Bevacizumab in Recurrent/Metastatic Colorectal Cancer
45 participantsStarted 2026-06-30
Plain-language summary
Nelmastobart（hSTC810） is a novel humanized monoclonal antibody that fuses on IgG4 and targets a novel immune checkpoint protein, BTN1A1+.This is an phase Ib bridging trial conducted in China to assess the safety, tolerability, and pharmacokinetic characteristics of Nelmastobart in combined with TAS-102 and Bevacizumab in Chinese participants with mCRC, and to verify that the safety results align with those from the Korean STCUBE-003 phase Ib trial. The phase Ib trial will also provide supportive data for conducting a randomized, double-blind, controlled Phase II study in China.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults ≥18 years old and of any gender when signing the informed consent form.
. Participants with metastatic/recurrent colorectal cancer confirmed by histopathology/cytology who have not responded to or are unable to receive standard anti-cancer therapy based on oxaliplatin and irinotecan. Participants who undergo curative surgery for colorectal cancer and receive adjuvant anti-cancer therapy will be considered to have received their first palliative anti-cancer therapy if their disease recurs during or within 6 months after completion of the adjuvant anti-cancer treatment.
. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, there must be at least one measurable or assessable lesion present.
. Participants with ECOG performance status 0-1
. Participants with adequate bone marrow and body organ functions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of DLT
Timeframe: up to 6 months
2
Permanent discontinuation of IP due to adverse drug reactions (ADRs)
. Participants who have hypersensitivity to the active ingredient of IP or any of its components (excipients)
. Participants who had cytotoxic chemotherapy within 14 days prior to randomization; treatment with IP in another clinical trial with the elapse of ≤2 weeks from the last dose of that IP or ≤5 folds the half-life of that IP; or treatment with monoclonal antibody therapy within the past 4 weeks
. Uncontrolled serious infection
. Confirmed PD during treatment with trifluridine/tipiracil for palliative care or confirmed recurrence within 6 months after the end of such treatment
. Participants requiring high-dose steroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants However, these participants may be enrolled in the following cases.
. Short-term (\<7 days) use of systemic corticosteroids that are considered standard of care will be allowed.
. Participants requiring intermittent use of bronchodilators, inhalant steroids, or local steroid injections will be allowed.
. Replacement therapy (e.g., thyroxine, insulin, physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered as a type of systemic treatment and will be allowed.