UPCC 33524 A Phase 1, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants with Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors

Study on Investigational Medication for Advanced Malignant Mesothelioma and Other Solid Tumors

Enrolling By Invitation
18 years or above
All
Phase 1
100 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Malignant Mesothelioma, Metastatic Malignant Solid Tumor, Advanced Solid Tumor
  • Age: 18 years or above
  • Gender: All

Inclusion 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 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:

  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 exclusion criteria may apply.

This study investigates an investigational medication for people with advanced or metastatic malignant mesothelioma or other solid tumors. The purpose of this study is to evaluate the safety, tolerability, and early effectiveness of the investigational medication. The study is conducted in two parts: a dose escalation part to determine the safest dose, and a dose selection optimization part to find the most effective dose.

Participants will receive the investigational medication and will be closely monitored for any side effects. The study will involve regular medical assessments, including blood tests and scans, to evaluate how the medication is affecting the body and the tumor. Participants will need to have at least one measurable tumor to be eligible for the study.

  • Who can participate: Adults aged 18 years or older with advanced or metastatic malignant mesothelioma or other solid tumors may participate. Key eligibility includes having previously received immune checkpoint therapy and platinum-based chemotherapy for mesothelioma, and a life expectancy of at least 12 weeks.
  • Study details: Participants will take the investigational medication and undergo regular health checks, including blood tests and imaging scans, to monitor their response to the treatment.
Updated on 17 Feb 2026. Study ID: 25-0066
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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