Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai JMT-Bio Inc.
About this trial
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of JMT108 Injection in this population. The study consists of Phase I and Phase II (including Phase IIa and Phase IIb), where Phase I is the dose-escalation stage, Phase IIa is the dose-expansion stage, and Phase IIb is the cohort-expansion stage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old.
Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma.
Participants with unresectable locally advanced or metastatic melanoma who have failed prior standard treatment or have no available standard treatment will be enrolled in Phase I and Phase IIa; those who have received or not received prior standard treatment will be enrolled in Phase IIb.
According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one measurable lesion.
Disqualifiers
Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other unapproved clinical trial drugs or treatments within 4 weeks prior to the first administration of the study drug.
Prior use of IL-2/IL-15 cytokine therapy.
Received major organ surgery (excluding needle biopsy) or experienced severe trauma within 4 weeks prior to the first administration of the study drug, or requires elective surgery during the study period.
Received systemic glucocorticoids or other immunosuppressive therapy within 14 days prior to the first use of the study drug. Exceptions include the following situations: receiving physiological replacement doses of hydrocortisone or other equivalent doses of hormonal therapy (i.e., prednisone ≤ 10 mg/day or other equivalent doses of hormones); receiving topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoid therapy; receiving short-course glucocorticoids for preventive treatment (e.g., prevention of contrast agent allergy).
Trial design
Design model
Sequential
Treatments tested in this trial
JMT108
DrugIntravenous (IV) administration
Treatment groups
188 Participants
are divided into 4 treatment groupsGroup A: Phase I: Dose Escalation StageExperimental treatment 1 intervention
Group B: Phase IIa: Dose Expansion StageExperimental treatment 1 intervention
Group C: Phase IIb: Cohort 1Experimental treatment 1 intervention
Group D: Phase IIb: Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-Limiting Toxicity (DLT) (Phase I)
To evaluate the safery of JMT108 in subjects.
Time frame
Approximately 28 days.2
Adverse Events (AEs) (Phase I)
To evaluate the safery of JMT108 in subjects.
Time frame
Through study completion, an average of 1 year3
Overall Response Rate (ORR) (Phase II)
Through study completion, an average of 1 year.
Time frame
To evaluate the efficacy of JMT108 in subjects.Secondary outcomes
1
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of JMT108 in subjects.
Time frame
Through study completion, an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov