New pill shows promise in early trial for tough cancers
NCT ID NCT06566079
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This early-stage trial is testing a new oral drug called ISM6331 in 100 adults with advanced mesothelioma or other solid tumors that have not responded to standard treatments. The study aims to find a safe dose and check for any early signs that the drug can shrink tumors. Participants take one capsule daily, and researchers will monitor side effects and how the drug moves through the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ISM6331 (a drug taken orally as a capsule once daily)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced mesothelioma or other solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 100 participants, so the drug may not prove safe or effective. Side effects are unknown, and it may not work for all tumor types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
RECRUITINGBeijing, China
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, China
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NEXT Oncology - Austin
RECRUITINGAustin, Texas, 78758, United States
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute at HealthONE
RECRUITINGDenver, Colorado, 80218, United States
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Shanghai Pulmonary Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Sun Yat-Sen University Cancer Center
RECRUITINGGuangzhou, China
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The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
RECRUITINGChicago, Illinois, 60637, United States
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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University of Pennsylvania - Abramson Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Can a vitamin supplement make chemotherapy hit mesothelioma harder?
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?