Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
InSilico Medicine Hong Kong Limited
Study ID
NCT06566079
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Malignant Mesothelioma
  • Metastatic Malignant Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ISM6331 — DRUG
    Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment.

Study Details

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).

Key Dates

Start date
Dec 27, 2024
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation
    Patients will receive ISM6331 once daily in sequential cohorts of increasing doses.
  • Experimental: Part 2 Dose Selection Optimization
    Participants will receive ISM6331 once daily at each dose level from the two dose levels recommended by Study Review Committee.

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT). [ Time Frame: Day 1 up to Day 31 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
The University of Chicago Medical Center - Duchossois Center for Advanced MedicineChicagoIllinois60637-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
University of Pennsylvania - Abramson Cancer CenterPhiladelphiaPennsylvania19104-
SCRI Oncology PartnersNashvilleTennessee37203-
NEXT Oncology - AustinAustinTexas78758-

Find similar trials in Denver, CO

By research site
Sarah Cannon Research Institute at HealthONE· Denver, COThe University of Chicago Medical Center - Duchossois Center for Advanced Medicine· Chicago, ILUniversity Hospitals Cleveland Medical Center· Cleveland, OHUniversity of Pennsylvania - Abramson Cancer Center· Philadelphia, PASCRI Oncology Partners· Nashville, TNNEXT Oncology - Austin· Austin, TX

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