Actively Recruiting
Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
Led by InSilico Medicine Hong Kong Limited · Updated on 2026-02-17
100
Participants Needed
10
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at the time of signing informed consent
- Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors with no effective standard therapy or failed standard therapy
- For Part 2, solid tumor participants (other than mesothelioma) must have genetic testing showing Hippo pathway dysregulation
- Participants with malignant mesothelioma must have prior immune checkpoint therapy and platinum-based chemotherapy
- At least one evaluable lesion in Part 1 or one measurable target lesion in Part 2 according to RECIST v1.1 or modified RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks as judged by the investigator
- Adequate organ function as determined by medical assessment within 7 days prior to first dose
- Ability to provide signed informed consent and comply with study requirements
You will not qualify if you...
- Previous treatment with a TEAD inhibitor
- Participation in other therapeutic clinical studies within 28 days or 5 half-lives prior to first dose
- Anti-tumor therapy within 28 days or 5 half-lives prior to first dose
- Known active central nervous system (CNS) primary tumor or untreated CNS metastases
- Severe or uncontrolled systemic diseases as judged by the investigator
- Inability or unwillingness to comply with oral drug administration or presence of gastrointestinal conditions
- Any clinically significant illness, medical condition, surgical history, physical finding, laboratory abnormality, or other condition that could affect study treatment or assessment
- Current use of strong inhibitors or inducers of P-gp, or sensitive substrates of P-gp, CYP1A2, CYP2B6, or CYP3A4 that cannot be stopped 14 days or 5 half-lives before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
2
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
4
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
NEXT Oncology - Austin
Austin, Texas, United States, 78758
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
8
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
9
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
10
Sun Yat-Sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
Q
Qinhan Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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