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.
Participants who participate in the study must meet all of the following 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 who meet any of the following exclusion criteria will be excluded from the study.
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
Single group
Nelmastobart in combination with TAS-102 and Bevacizumab
Drug1. 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)
Incidence of DLT
Definition of DLT: The severity of AEs observed during the trial was determined and recorded according to the NCI CTCAE v6.0 grading criteria. The DLT observation period spanned the first treatment cycle (i.e., from C1D1, the first administration, to C1D28).According to the definition of DLT, "drug-related" is defined as follows: an AE is considered to be related to the investigational product if, in the opinion of the investigator, the relationship is "definitely related," "likely related," or "possibly related."
Permanent discontinuation of IP due to adverse drug reactions (ADRs)
The incidence and rate of permanent discontinuation of IP due to adverse drug reactions (ADRs)
AEs(Adverse Events)
Status of AEs will be presented with frequency, percentage and its 95% CI. AEs will be classified by SOC and PT of MedDRA (latest version) and presented with frequency, percentage and its 95% CI.
Maximum plasma concentration (Cmax)
Maximum plasma concentration of Nelmastobart to evaluate PK parameters for the first and the subsequent cycles.
Objective response rate (ORR)
To evaluated by the Independent Review Committee (IRC) in accordance with the RECIST1.1 criteria.
Immunogenicity indicators:
Incidence of antibody formation against drugs (ADA)
Tmax(Time to Maximum Plasma Concentration)
Time to reach Tmax of Nelmastobart to evaluate the PK parameters for the first and the subsequent cycles.
Exploratory evaluation indicators.
The level of BTN1A1 expression in the tumor tissue samples of the subjects
ORR between different levels of BTN1A1
The difference in ORR between patients with positive and negative BTN1A1 results
Efficacy vs. BTN1A1
The correlation between the expression levels of BTN1A1 and efficacy indicators
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