The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer

NCT07134205 | Not Yet Recruiting Phase 3

• 1 other identifier: JMT101-017
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.

Conditions

Metastatic Colorectal Cancer (mCRC)

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  defined as the time from randomization to the first occurrence of disease progression as determined by the BIRC with use of RECIST v1.1 or death from any cause, whichever occurs first.

  Up to approximately 3 years

Secondary Outcomes (10)

• Overall response rate (ORR)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Progression-free Survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 5 years

Study Arms (2)

JMT101 + Irinotecan

EXPERIMENTAL

JMT101, 6 mg/kg, Irinotecan, 180mg/m\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).

Drug: JMT101; Drug: Irinotecan

Standard of care

ACTIVE COMPARATOR

28 day for one cycle.

Drug: Regorafenib

Interventions

JMT101 DRUG

JMT101, 6 mg/kg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).

JMT101 + Irinotecan

Irinotecan DRUG

Irinotecan, 180mg/m\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).

JMT101 + Irinotecan

Regorafenib DRUG

Regorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.

Standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ranged from 18 to 75 years old (inclusive), regardless of gender;
• \. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR/MSI-H;
• \. Tumor tissue available for central laboratory testing;
• \. Metastatic colorectal cancer with disease progression after 2nd line treatment; previously received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan; patients are allowed to previously receive EGFR and/or VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib;
• \. Measurable disease according to RECIST1.1;
• \. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
• \. Life expectancy ≥3 months
• \. Adequate main organs and bone marrow function.
• \. Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.

You may not qualify if:

• \. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.
• \. Central nervous system metastasis or meningeal metastasis;
• \. Patients with high risk of bleeding due to tumor invasion of important arteries;
• \. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
• \. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;
• \. Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;
• \. Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, etc. within 21 days before the first dose of the study drug; radiotherapy within 2 weeks before the first dose of the study drug; Chinese medicine or Chinese patent medicine with anti-tumor effect within 1 week before the first dose of the study drug;
• \. Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;
• \. Use of immunosuppressive medications within 14 days prior to the first dose of study drug;
• \. Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors or strong UGT1A9 inhibitors within 2 week, or those who cannot suspend the use of the above drugs during the study;
• \. Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;
• \. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
• \. Have a history of serious cardiovascular disease;
• \. Previous or current presence of interstitial pneumonia/lung disease;
• \. History of autoimmune diseases;

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-07