Actively Recruiting
A Phase 1, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM6331 in Adults With Advanced or 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ISM6331, an investigational drug, in adults with advanced or metastatic malignant mesothelioma or other solid tumors who have limited treatment options. This Phase 1, open-label, multicenter trial aims to assess the safety, tolerability, recommended dose for further study, how the drug is processed in the body, and early signs of anti-tumor activity. The trial includes two parts: dose escalation to find safe dosing levels, and dose selection to optimize treatment dose.
CONDITIONS
Brief 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...
- Adults aged 18 years or older at consent
- Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors
- For Part 2, solid tumors other than mesothelioma must show Hippo signaling pathway dysregulation by genetic testing
- Malignant mesothelioma patients must have prior immune checkpoint therapy and platinum-based chemotherapy
- At least one evaluable or measurable lesion per 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
- Adequate organ function within 7 days before first study dose
- Able to provide informed consent and comply with study requirements
You will not qualify if you...
- Prior treatment with a TEAD inhibitor
- Participation in other therapeutic clinical studies within 28 days or 5 half-lives prior to first study dose
- Anti-tumor therapy within 28 days or 5 half-lives prior to first study dose
- Active central nervous system primary tumor or untreated CNS metastases
- Severe or uncontrolled systemic diseases
- Unable or unwilling to comply with oral drug administration or has gastrointestinal conditions affecting this
- Clinically significant illness or conditions affecting drug absorption or study assessments
- Currently using strong inhibitors or inducers of P-gp or sensitive substrates of CYP enzymes that cannot be stopped 14 days before dosing
- Other protocol-specific exclusions as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive ISM6331 capsules once daily as part of dose escalation or dose selection cohorts to evaluate safety and efficacy.
Regular visits during treatment for dosing and safety assessments
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
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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