A Phase 1, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female participants with age ≥18 years at the time of signing the informed consent.

• Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors, who have failed standard therapy or for whom no effective standard therapy exists, participants for part 1 is regardless of the presence or absence of the genetic alterations of the Hippo pathway, but for part 2 participants with solid tumors other than mesothelioma, genetic testing documentation must demonstrate Hippo signaling pathway dysregulation.

• Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy and platinum-based chemotherapy.

• Presence of at least one evaluable lesion in Part 1 or one measurable target lesion in Part 2 according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for participants with non-pleural mesothelioma or other solid tumors and modified RECIST (mRECIST) v1.1 for participants with malignant pleural mesothelioma.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.

• Life expectancy of ≥12 weeks as judged by the investigator.

• Adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment).

• Capable of providing signed informed consent form (ICF) and complying with the requirements and restrictions listed in the ICF and in this study protocol.

Locations
United States
Colorado
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Illinois
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
RECRUITING
Chicago
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania - Abramson Cancer Center
RECRUITING
Philadelphia
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
NEXT Oncology - Austin
RECRUITING
Austin
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Qinhan Chen
Insilico-Clinicaltrial@insilico.ai
+86 021-50831718
Time Frame
Start Date: 2024-12-27
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 82
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: InSilico Medicine Hong Kong Limited

This content was sourced from clinicaltrials.gov