Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSTCube, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥19 years old at the time of written informed consent
Patients with histologically/cytologically confirmed metastatic/recurrent colorectal cancer after failure of, or not eligible for oxaliplatin and irinotecan-based standard anticancer therapy (If a subject had a radical surgery for colorectal cancer followed by adjuvant anticancer therapy, and the disease recurred during the adjuvant anticancer therapy or within 6 months from the end of the adjuvant anticancer therapy, the adjuvant anticancer therapy will be considered primary palliative therapy.)
Subjects with at least one evaluable lesion, or non-measurable but evaluable lesion according to RECIST v1.1
Subjects with ECOG performance status 0-1
Disqualifiers
Patients who have hypersensitivity to the active ingredient of IP or any of its components (excipients)
Individuals 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
Trial design
Design model
Sequential
Treatments tested in this trial
Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab
DrugTrifluridine/tipiracil is dose-deescalated from 35 mg/m² to 30 mg/m² and 25 mg/m² to determine the RP2D, in combination with fixed doses of Nelmastobart and Bevacizumab, in patients with metastatic colorectal cancer who are refractory or intolerant to prior oxaliplatin- and irinotecan-based chemotherapy.
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Nelmastobart 800 mg+Trifluridine/Tipiracil+BevacizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of DLT
Status of DLT will be presented with frequency, percentage and its 95% confidence interval (CI).
Time frame
up to 6 months2
RP2D(Recommended Phase 2 Dose)
The recommended phase 2 dose (RP2D) of nelmastobart in combination with trifluridine/tipiracil and bevacizumab
Time frame
up to 2 years3
MTD(Maximum Tolerated Dose)
To find the maximum tolerated dose (MTD)
Time frame
up to 2 years4
Progression Free Survival (PFS) rate
Time from the start of treatment to objective tumor progression or all-cause death will be presented with survival curve, median survival time and its 95% CI using the Kaplan-Meier estimation.
Time frame
up to 2 yearsSecondary outcomes
1
Phase 2 study; Overall Survival (OS)
Time from the start of treatment to all cause death
Time frame
up to 2 years2
Phase 2 study; Objective Response Rate (ORR)
Investigator assessed ORR defined by RECIST 1.1 or iRECIST
Time frame
up to 2 years3
Maximum plasma concentration (Cmax)
Maximum plasma concentration of Nelmastobart to evaluate PK parameters
Time frame
up to 6 months4
Phase 2 study; Disease Control Rate (DCR)
Investigator assessed DCR at 16 weeks defined by RECIST 1.1 or iRECIST
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov