Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

NCT04689100 | Unknown Phase 1

• 1 other identifier: JMT101-ECL
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)).

  From enrollment until 30 days after the last dose

• Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).

  Time from the first dose of study drug up to 4 weeks

• Maximum Tolerated Dose (MTD)

  28 days

Secondary Outcomes (10)

• Objective Response Rate (ORR)

  From first dose to disease progression or end of study, an average of 1 year

• Disease control rate (DCR).

  From first dose to disease progression or end of study, an average of 1 year

• Progression free survival (PFS).

  From first dose to disease progression or end of study, an average of 1 year

• Overall survival (OS).

  From first dose to death or end of study, an average of 1 year

• Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.

  From enrollment until 30 days after the last dose

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Drug: JMT101

Dose Expansion Cohort

EXPERIMENTAL

Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.

Drug: JMT101

Interventions

JMT101 DRUG

Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)

Also known as: FOLFIRI(Irinotecan, Leucovorin Calcium, and Fluorouracil); mFOLFOX6((Oxaliplatin, Leucovorin Calcium, and Fluorouracil);

Dose Escalation Cohort

Eligibility Criteria

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

You may qualify if:

• Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type.
• At least 1 measurable lesion according to RECIST 1.1;
• ECOG score 0 or 1;
• Stable for more than 14 days of brain metastasis or spinal cord compression.

You may not qualify if:

• Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment.
• The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment.
• Known hypersensitivity to any ingredient of JMT101 or their excipients;
• Major surgery within prior 4 weeks of first treatment.
• Receiving an investigational product in another clinical study within 4 weeks;
• History of serious systemic diseases;
• Pregnancy or lactating wo

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

Study Sites (9)

Beijing Luhe Hospital. Capital Medical University

Beijing, China

RECRUITING

Peking University Cancer Hospital

Beijing, China

RECRUITING

The first affiliated hospital of bengbu medical college

Bengbu, China

RECRUITING

The First People's Hospital of Changzhou

Changzhou, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, China

RECRUITING

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

Zhongshan Hospital

Shanghai, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

NOT YET RECRUITING

MeSH Terms

Interventions

Leucovorin; Fluorouracil; Irinotecan

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Officials

• Xiugao Yang

  Department of Medicine, CSPC Clinical Development Division

  STUDY CHAIR

Central Study Contacts

Xiugao Yang

CONTACT

8021-60677906; yangxiugao@mail.ecspc.com

Rong Hu

CONTACT

8021-60673935; hurong@mail.ecspc.com

Study Design

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

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 30, 2020
• Study Start: April 11, 2017
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

CN (9)