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Nelmastobart in Combination With Tas-102 and Bevacizumab in Recurrent/Metastatic Colorectal Cancer

NCT07656038 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-06-18

No results posted yet for this study

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.

Conditions

  • Colonrectal Cancer (CRC)

Interventions

DRUG

Nelmastobart in combination with TAS-102 and Bevacizumab

1. Drug name: Nelmastobart. Specifications: 400 mg/8 ml. Formulation: Sterile concentrated solution for injection. Batch number: XXX. Manufactured and supplied by Samsung Biologics Co., Ltd. (SBL), on behalf of STCube, Inc. 2. Drug name: Qufluorodeoxyuridine/tipiracil. Specifications: 15mg, 20mg. Formulation: film-coated tablet. Batch number: XXX. Produced and supplied by Taiho Pharmaceutical Co., Ltd. 3. Drug name: Bevacizumab. Specifications: 100 mg, 400 mg. Formulation: concentrated solution for injection. Batch number: XXX. Produced and supplied by XXX Company. Experimental: Cohort (Phase 1b) Nelmastobart 800 mg + Tas102 35 mg/m² + Bevacizumab 5 mg/kg (Starting Dose)

Sponsors & Collaborators

  • STCube, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-07-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07656038 on ClinicalTrials.gov