Can a pill target multiple Hard-to-Treat cancers?
NCT ID NCT07755397
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental pill called JBI-778 in people with certain advanced cancers: EGFR-mutated lung cancer (with or without brain metastases), recurrent high-grade glioma, or adenoid cystic carcinoma. The drug is designed to block a protein that helps cancer cells grow. The study aims to find a safe dose and see how the body processes the drug, while also checking for any signs that it shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JBI-778, an oral PRMT5 inhibitor taken as capsules once daily
- What this could lead to
- If successful, this could lead to a new targeted treatment option for certain hard-to-treat cancers, including lung cancer with brain metastases and recurrent glioma.
- What could go wrong
- This is an early-phase, first-in-human trial with a small number of participants, so safety and effectiveness are not yet established. The drug may cause side effects or may not work as hoped.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Apr 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 aged ≥18 years. 2. Histologically or cytologically confirmed: 1. EGFR-mutated non-small cell lung cancer (NSCLC) with or without brain metastases previously treated with an EGFR inhibitor; or 2. IDH-mutated WHO Grade 3/4 recurrent glioma; or 3. Adenoid cystic carcinoma (ACC) with recurrent, metastatic, or advanced incurable disease. 3. At least one measurable lesion according to RECIST v1.1 and/or RANO criteria, as applicable. 4. ECOG performance status ≤2. 5. Adequate hematologic, hepatic, renal, and coagulation function. 6. Resolution of clinically significant toxicities from prior therapy to Grade 0 or 1, except permitted residual toxicities. 7. Life expectancy of at least 3 months. 8. Able to swallow oral medication. 9. Availability of tumor tissue and/or liquid biopsy suitable for next-generation sequencing. 10. Willing to use highly effective contraception during study participation and for at least 3 months after the last dose of study treatment. 11. Able and willing to provide written informed consent. Exclusion Criteria: 1. Systemic anticancer therapy or investigational therapy within 2 weeks or 5 half-lives prior to study treatment. 2. Major surgery within 21 days before study treatment. 3. Radiotherapy within 4 weeks for brain metastases or within 2 weeks for other disease sites. 4. Significant uncontrolled cardiovascular, metabolic, psychiatric, or other serious medical conditions. 5. QTcF \>450 msec in males or \>470 msec in females. 6. History of optic neuritis or optic neuropathy. 7. Active HIV infection or active hepatitis B or C infection. 8. Active infection requiring systemic antibiotic therapy. 9. Use of strong CYP3A inhibitors or inducers within protocol-specified washout periods. 10. Gastrointestinal conditions that may significantly affect drug absorption. 11. Pregnancy or breastfeeding. 12. Participation in another interventional clinical study. 13. Previous treatment with JBI-778. 14. Any condition that, in the opinion of the investigator, would place the participant at unacceptable risk or interfere with study participation.
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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
6 sites. 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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All India Institute of Medical Sciences(AIIMS)
RECRUITINGNew Delhi, National Capital Territory of Delhi, 110029, India
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HCG Manavata Cancer Centre
RECRUITINGNashik, Maharashtra, 422002, India
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Kiran Super Multi-Speciality Hospital
RECRUITINGSurat, Gujarat, 395004, India
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Oncoville Cancer Hospital and Research Center
RECRUITINGBangalore, Karnataka, 560072, India
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SunAct Cancer Institute Pvt Ltd
RECRUITINGThane, Maharashtra, 400615, India
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Tata Memorial Center
RECRUITINGMumbai, Maharashtra, 400012, India
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