Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
NCT ID: NCT06566079
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
82 participants
INTERVENTIONAL
2024-12-27
2028-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation
Patients will receive ISM6331 once daily in sequential cohorts of increasing doses.
ISM6331
Dosage form: Capsule for oral administration.
Frequency of administration: Once daily overall of treatment.
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.
ISM6331
Dosage form: Capsule for oral administration.
Frequency of administration: Once daily overall of treatment.
Interventions
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ISM6331
Dosage form: Capsule for oral administration.
Frequency of administration: Once daily overall of treatment.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy and platinum-based chemotherapy.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
6. Life expectancy of ≥12 weeks as judged by the investigator.
7. Adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment).
8. Capable of providing signed informed consent form (ICF) and complying with the requirements and restrictions listed in the ICF and in this study protocol.
Exclusion Criteria
2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
3. Anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
4. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
6. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition
7. Have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, laboratory abnormality or any other conditions that, in the investigator's opinion, would not be in the best interest of the participant; or that could alter the absorption, distribution, metabolism, or excretion of the study treatment; or impair the assessment of study result.
8. Currently receiving any of Strong inhibitors or inducers of P-gp, or Sensitive substrates of P-gp, CYP1A2, CYP2B6, and CYP3A4 that cannot be discontinued 14 days or 5 half-lives for inhibitors or substrates (whichever is shorter) prior to the first dose of study treatment.
18 Years
ALL
No
Sponsors
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InSilico Medicine Hong Kong Limited
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology - Austin
Austin, Texas, United States
Henan Cancer Hospital
Zhengzhou, Henan, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Sun Yat-Sen University Cancer Center
Guangzhou, , China
Countries
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Central Contacts
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Other Identifiers
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ISM6331-101
Identifier Type: -
Identifier Source: org_study_id
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