Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
NCT Number: NCT06566079
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Malignant Mesothelioma|Metastatic Malignant Solid Tumor|Advanced Solid Tumor
Interventions: DRUG: ISM6331
Sponsor: InSilico Medicine Hong Kong Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-30
Completion Date: 2028-02-28

Summary:
This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).

Primary Outcome Measures: Incidence of dose-limiting toxicity (DLT)., DLT is defined as any adverse event which meets DLT criteria unless it is clearly related to disease progression or intercurrent illness during the first 31 days after the initiation of treatment in the dose escalation part (Part 1)., Day 1 up to Day 31|Incidence and severity of adverse events (AEs), Adverse events are assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 \[NCI CTCAE v5.0\], Approximately 12 months.|Incidence of clinically significant abnormalities in laboratory values, vital signs, physical examination, and electrocardiogram (ECG) measurements., Regular monitoring and assessment of vital signs (pulse rate, blood pressure, respiratory rate, and temperature), physical examinations, laboratory values, ECG, and other safety examinations by investigators., Approximately 12 months.|Recommended Phase 2 Dose (RP2D), The RP2D will be recommended by safety review committee (SRC) upon reviewing all available safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data from Part 1 and Part 2., Approximately 40 months
Secondary Outcome Measures: Maximum observed concentration (Cmax), Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed., Approximately 12 months|Area under the concentration-time curve (AUC), Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed., Approximately 12 months|Terminal half-life (t1/2), Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed., Approximately 12 months|Objective response rate (ORR)., Efficacy assessments will be conducted at baseline and every 8 weeks within the first 6 months after the first dose of study treatment, then every 12 weeks thereafter, until progressive disease confirmed by the investigator, start of a new anti-tumor treatment, death, lost to follow-up, or withdrawal from the study, whichever occurs first., Approximately 12 months|Best objective response (BOR)., Efficacy assessments will be conducted at baseline and every 8 weeks within the first 6 months after the first dose of study treatment, then every 12 weeks thereafter, until progressive disease confirmed by the investigator, start of a new anti-tumor treatment, death, lost to follow-up, or withdrawal from the study, whichever occurs first., Approximately 12 months|Duration of response (DoR)., Efficacy assessments will be conducted at baseline and every 8 weeks within the first 6 months after the first dose of study treatment, then every 12 weeks thereafter, until progressive disease confirmed by the investigator, start of a new anti-tumor treatment, death, lost to follow-up, or withdrawal from the study, whichever occurs first., Approximately 12 months