JMT106 Injection in the Treatment of Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai JMT-Bio Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
JMT106 Injection
DrugUse according to the protocol.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: JMT106 injection as single agentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Event (AE),
Assess the incidence of all AE and serious adverse events (SAE)..
Time frame
Up to 2 years2
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).
Time frame
Up to 1 years3
Dose-Limiting Toxicity (DLT)
Evaluate the incidence of DLT in different dose groups.
Time frame
Up to 1 years4
Dose for Expansion (RDE)
Explore the recommended dose for the cohort expansion phase.
Time frame
Up to 1 yearsSecondary outcomes
1
Plasma concentrations and pharmacokinetic (PK) parameters
Tests are conducted after administration of JMT106.
Time frame
About 6 months after first dosing2
2. Title: ORR
ORR as Assessed by Investigator according to RECIST v1.1
Time frame
Up to 2 years3
Disease Control Rate (DCR)
DCR according to RECIST v1.1
Time frame
Up to 2 years4
Progression-Free Survival (PFS)
PFS as Determined by Investigator according to RECIST v1.1
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov