RecruitingPhase 1 / Phase 2

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

A Phase 1/2, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ISM6331 in adults with mesothelioma, a cancer of the lining around organs, or other solid tumors that are advanced or have spread. It checks safety, side effects, how the drug works in the body, and whether it fights cancer. The study has two parts to help choose a dose for further testing.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • A tissue test shows advanced cancer that cannot be removed by surgery or has spread. Standard treatment has failed, or no effective standard treatment exists.
  • For Part 2, cancers other than mesothelioma must have genetic test results showing changes in the Hippo pathway, which helps control cell growth. Part 1 does not require these changes.
  • If you have mesothelioma, you must have had both immune checkpoint therapy, which helps the immune system fight cancer, and platinum-based chemotherapy.
  • You have at least one tumor area that can be checked in Part 1 or measured in Part 2 using the study's rules.
  • You can do daily activities with little or no limit. The study doctor expects you to live at least 12 weeks.
  • Tests within 7 days before your first dose show that your organs work well enough.
  • You can sign a consent form and follow the study rules.

Who can't join

  • You have taken a TEAD inhibitor, a type of drug that blocks TEAD proteins.
  • You recently joined another treatment study or received cancer treatment: within 28 days or 5 drug half-lives, whichever is shorter. A half-life is the time for half a drug to leave the body.
  • You have a known active tumor that started in the brain or spinal cord, or untreated cancer that has spread there.
  • The study doctor finds a severe or uncontrolled illness affecting your body.
  • You cannot or will not follow the rules for taking medicine by mouth, or you have a stomach or bowel condition.
  • You have an illness, past surgery, abnormal test result, or other condition that the doctor believes could make the study unsafe, change how your body handles the drug, or affect study results.
  • You take certain medicines that affect P-gp or are processed by P-gp, CYP1A2, CYP2B6, or CYP3A4, proteins that move or break down drugs, and cannot stop them within the required time before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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. 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.

Study sites (6)

CO

IL

  • The University of Chicago Medical Center - Duchossois Center for Advanced Medicine · Chicago, IL 60637More trials in Chicago

OH

PA

TN

TX