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New treatment option for Malignant Mesothelioma
Official title Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
ClinicalTrials.gov ID: NCT06566079
What this study is testing
What is ISM6331?
ISM6331 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for malignant mesothelioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female participants with age ≥18 years at the time of signing the informed consent.
- Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors, who have failed standard therapy or for...
- Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy and platinum-based chemotherapy.
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
You likely can't join if
- Participants who have previously received a TEAD inhibitor.
- Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- Anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- Known active central nervous system (CNS) primary tumor or untreated CNS metastases.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
- Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition
See the full eligibility criteria
- Male or female participants with age ≥18 years at the time of signing the informed consent.
- 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...
- Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy and platinum-based chemotherapy.
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
- Life expectancy of ≥12 weeks as judged by the investigator.
- Adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment).
- Capable of providing signed informed consent form (ICF) and complying with the requirements and restrictions listed in the ICF and in this study protocol.
- Participants who have previously received a TEAD inhibitor.
- Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- Anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- Known active central nervous system (CNS) primary tumor or untreated CNS metastases.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
- Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Chicago, Illinois, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Zhengzhou, Henan, China
- Shanghai, Shanghai Municipality, China
- Beijing, China
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Chicago, Illinois, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Austin, Texas, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.