JMT106 Injection in the Treatment of Advanced Solid Tumors

NCT07275073 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JMT106-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors

Conditions

Advanced Solid Tumor; Lung Squamous Cell Carcinoma; Hepatocellular Carcinoma

Keywords

solid tumor

Outcome Measures

Primary Outcomes (6)

• Adverse Event (AE),

  Assess the incidence of all AE and serious adverse events (SAE)..

  Up to 2 years

• Maximum Tolerated Dose (MTD),

  MTD is defined as the dose level at which the estimated value of toxicity probability is closest to the target toxicity rate (i.e., 0.3).

  Up to 1 years

• Dose-Limiting Toxicity (DLT)

  Evaluate the incidence of DLT in different dose groups.

  Up to 1 years

• Dose for Expansion (RDE)

  Explore the recommended dose for the cohort expansion phase.

  Up to 1 years

• Recommended Phase 2 Dose (RP2D)

  Recommended phase II dose

  Up to 1 years

• Overall Response Rate (ORR)

  Up to 2 years

  ORR as Assessed by Investigator according to RECIST v1.1

Secondary Outcomes (7)

• Plasma concentrations and pharmacokinetic (PK) parameters

  About 6 months after first dosing

• 2. Title: ORR

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Duration of Response (DoR)

  Up to 2 years

Study Arms (1)

JMT106 injection as single agent

EXPERIMENTAL

Drug: JMT106 Injection

Interventions

JMT106 Injection DRUG

Use according to the protocol.

JMT106 injection as single agent

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Histologically or cytologically confirmed advanced solid tumor.
• Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment at the current stage.
• At least one measurable lesion according to RECIST 1.1 criteria.
• ECOG performance status of 0-1.
• Expected survival ≥3 months.
• Sufficient organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factor treatment within 14 days):
• Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
• Platelets (PLT) ≥90×10⁹/L;
• Hemoglobin (Hb) ≥90 g/L;
• Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for liver metastases or hepatocellular carcinoma);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for liver metastases or hepatocellular carcinoma);
• Creatinine clearance (Ccr) \>50 mL/min (calculated by Cockcroft-Gault formula);
• Activated partial thromboplastin time (APTT) ≤1.5×ULN; INR ≤1.5×ULN.
• Fertile participants (male and female) must agree to use reliable contraception (hormonal, barrier, or abstinence) with their partners during the trial and for at least 180 days after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.

You may not qualify if:

• Previous treatment with anti-GPC3 therapy.
• Presence of spinal cord compression or clinically active central nervous system metastases (untreated or symptomatic metastases, or those requiring corticosteroids/anticonvulsants for symptom control), or carcinomatous meningitis. Patients with previously treated brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may be enrolled if clinically stable for ≥4 weeks with no imaging evidence of progressive brain metastases.
• Long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy (e.g., \>20 mg prednisone or equivalent), excluding those using nasal spray, inhaled, or other topical glucocorticoid therapies.
• Adverse reactions from prior antitumor therapy not recovered to CTCAE 5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, e.g., alopecia).
• Any antitumor therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational intervention within 4 weeks or 5 half-lives (whichever is shorter) before the first dose, or traditional Chinese medicine with antitumor indications within 14 days prior.
• Grade ≥3 immune-related adverse events (irAEs, per CTCAE 5.0) from prior immunotherapy.
• Concurrent participation in another interventional clinical trial (observational trials or follow-up phases allowed).
• Major surgery within 28 days before the first dose or planned tumor resection during the study.
• Significant bleeding tendency within 4 weeks before the first dose, or high-risk conditions (e.g., gastrointestinal hemorrhage, severe hemoptysis) per investigator judgment; hereditary bleeding disorders.
• Known severe allergy to the study drug or its excipients.
• Active bacterial, fungal, or viral infection requiring IV treatment within 14 days before randomization (prophylactic therapy allowed if no active infection symptoms); patients with viral hepatitis are allowed to receive antiviral treatment.
• Uncontrolled effusions (pleural, peritoneal, pericardial) requiring frequent drainage or intervention within 14 days before the first dose (excluding cytologic evaluation of effusions).
• History of allogeneic organ or hematopoietic stem cell transplantation.
• Immunodeficiency, including HIV-positive status.
• HBsAg-positive or HBcAb-positive with HBV-DNA \>2000 IU/mL; HCV antibody-positive with HCV-RNA positivity.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

The First Affilicated Hospital,Zhejiang University School of Medicine

Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Liang Ting bo, Ph.D

CONTACT

0571-87236666; liangtingbo@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: December 10, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): November 15, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-08

Locations

CN (1)