Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic Colorectal Cancer (CRC)Recurrent Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

Incidence of DLT
Status of DLT will be presented with frequency, percentage and its 95% confidence interval (CI).
up to 6 months
RP2D(Recommended Phase 2 Dose)
The recommended phase 2 dose (RP2D) of nelmastobart in combination with trifluridine/tipiracil and bevacizumab
up to 2 years
MTD(Maximum Tolerated Dose)
To find the maximum tolerated dose (MTD)
up to 2 years
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.
up to 2 years

Secondary Outcomes (8)

Phase 2 study; Overall Survival (OS)
up to 2 years
Phase 2 study; Objective Response Rate (ORR)
up to 2 years
Maximum plasma concentration (Cmax)
up to 6 months
Phase 2 study; Disease Control Rate (DCR)
up to 2 years
PFS(Progression free survival)
up to 2 years
+3 more secondary outcomes

Study Arms (1)

Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab

EXPERIMENTAL

3 reducing doses of Trifluridine/Tipiracil will be administered to participants

Drug: Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab

Interventions

Nelmastobart 800 mg+Trifluridine/Tipiracil+ BevacizumabDrug

Trifluridine/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.

Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.)

Sponsors & Collaborators

STCube, Inc.
Industrylead

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

NOT_YET_RECRUITING

Keun-Wook LeePRINCIPAL INVESTIGATOR

Seoul National University Hospital

Seoul, KR, 03080, South Korea

NOT_YET_RECRUITING

Sae-Won HanPRINCIPAL INVESTIGATOR

Severance Hospital

Seoul, KR, 03722, South Korea

NOT_YET_RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Trifluridine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Thymidine

Central Study Contacts

Hyunju Yoo

CONTACT

+8225513370 ID@stcube.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

March 13, 2025

Study Start

June 9, 2025

Actual (reported)

Primary Completion

December 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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
Individuals requiring high-dose steroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants
However, these individuals may be enrolled in the following cases.
Short-term (\<7 days) use of systemic corticosteroids that are considered standard of care will be allowed.
Subjects 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.
Pregnant or lactating women
Individuals with a history of autoimmune disease requiring systemic treatment (i.e., use of disease modifying therapy, corticosteroids, or immunosuppressants) within 2 years prior to the screening visit (However, enrollment will be possible for subjects with vitiligo, psoriasis not requiring systemic treatment, type 1 diabetes mellitus, hypothyroidism stably managed with hormone replacement therapy, Sjogren's syndrome, or resolved pediatric asthma/atopy.)
Individuals with active central nervous system lesions (radiologically unstable or symptomatic brain lesions). With the exception of patients with meningeal metastasis, individuals who had radiotherapy or surgical treatment may be enrolled if there is evidence that the patient's condition is maintained without steroid therapy and that the disease of the brain lesion has not progressed for ≥4 weeks.
Individuals with a documented history of cerebrovascular events (stroke or transient ischemic attack), unstable angina pectoris, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to the screening visit
Patients with hypertensive encephalopathy or hypertension that is not adequately controlled with antihypertensives
Individuals with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonia; or with active pneumonia based on screening chest X-rays
+18 more criteria

Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (8)

Study Arms (1)

Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (8)

Study Arms (1)

Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations