Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

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

JMT101

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

SG001

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

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

Regorafenib (Stivarga)

Clinical Trials Information Group officer

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).

A Study of JMT101 in Patients With Metastatic Colorectal Cancer

A Randomized, Controlled, Open-label Phase Ⅱ Study of The Safety, Tolerability and Efficacy of JMT101 and Irinotecan Combined With SG001 in Patients With Metastatic Colorectal Cancer (mCRC)

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

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

Duration from the date of initial treatment to the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of JMT101 in Patients With Metastatic Colorectal Cancer	NCT06089330	Metastatic Colo...	JMT101 SG001 Irinotecan Regorafenib (St...	18 Years - 75 Years	Shanghai JMT-Bio Inc.
A Study of JMT101 in Patients With Metastatic Colorectal Cancer	NCT06089330	Metastatic Colo...	JMT101 SG001 Irinotecan Regorafenib (St...	18 Years - 75 Years	Shanghai JMT-Bio Inc.

Spots Global Cancer Trial Database for regorafenib (stivarga)