A Study of JMT101 in Patients With Metastatic Colorectal Cancer

NCT06089330 | Unknown Phase 2

• 1 other identifier: JMT101-011
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a phase Ⅱ, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with Irinotecan and SG001 in Patients with Metastatic Colorectal Cancer (mCRC).

Conditions

Metastatic Colorectal Cancer (mCRC)

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT)

  After1 cycle of treatment of the safety run-in phase patients (each cycle is 28 days)

• Overall response rate (ORR)

  Up to approximately 2 years

• Incidence and severity of adverse events (AE) and serious adverse events (SAE)

  Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

  Up to approximately 2 years

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

Study Arms (3)

JMT101+SG001+ Irinotecan

EXPERIMENTAL

Drug: JMT101; Drug: SG001; Drug: Irinotecan

JMT101+Irinotecan

EXPERIMENTAL

Drug: JMT101; Drug: Irinotecan

Regorafenib (Stivarga)

ACTIVE COMPARATOR

Drug: Regorafenib (Stivarga)

Interventions

JMT101 DRUG

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

JMT101+Irinotecan; JMT101+SG001+ Irinotecan

SG001 DRUG

240 mg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

JMT101+SG001+ Irinotecan

Irinotecan DRUG

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

JMT101+Irinotecan; JMT101+SG001+ Irinotecan

Regorafenib (Stivarga) DRUG

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

Regorafenib (Stivarga)

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, or TAS-102;
• 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:

• Previously used anti PD-1, anti PD-L1, anti CTLA-4, or cellular immunotherapy;
• 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;
• Patients who require continuous use of morphine-based drugs to control pain;
• 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 UGT1A1 inhibitors within 1 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;

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 18, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share