RecruitingPhase 1 / Phase 2NCT06566079
Official study title

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

Study summary

This is a Phase 1/2, 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 mesothelioma or other Advanced solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection expansion part (Part 2).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedISM6331

The study team can explain what participation involves.

Who it may be forMesothelioma · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?InSilico Medicine Hong Kong Limited

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
InSilico Medicine Hong Kong Limited
Interventions being studied
Drug: ISM6331
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Male or female participants with age ≥18 years at the time of signing the informed consent. 2. Histologically confirmed unresectable advanced or metastatic mesothelioma or other advanced 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.

Reasons someone may not be able to joinExclusion criteria

1. Participants who have previously received a TEAD inhibitor. 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. Other protocol inclusion and

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Sarah Cannon Research Institute at HealthONEDenver, Colorado
  • The University of Chicago Medical Center - Duchossois Center for Advanced MedicineChicago, Illinois
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • University of Pennsylvania - Abramson Cancer CenterPhiladelphia, Pennsylvania
  • SCRI Oncology PartnersNashville, Tennessee
  • NEXT Oncology - AustinAustin, Texas
  • Henan Cancer HospitalZhengzhou, Henan
  • Shanghai Pulmonary HospitalShanghai, Shanghai Municipality
  • Cancer Hospital Chinese Academy of Medical SciencesBeijing
  • Sun Yat-Sen University Cancer CenterGuangzhou

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2026. Always confirm current availability with the study team.

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