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
Qualifiers
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
Treatments tested in this trial
- JMT106 Injection
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov