First‑in‑human test of JBI-778 in lung cancer, glioma, and salivary gland cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter Phase 1, open-label, dose-escalation and consolidation trial of JBI-778. The study uses a 3+3 design starting at 40 mg daily, with planned escalation up to about 160 mg or the pharmacologically active dose, followed by a consolidation period at the recommended dose. Eligible participants include adults with EGFR-mutated NSCLC (with or without brain metastases), IDH-mutated WHO grade 3/4 glioma, or recurrent/metastatic/ad advanced ACC. Primary goals focus on safety, pharmacokinetics, and pharmacodynamics, while secondary data may reveal preliminary clinical activity. Tissue and/or liquid biopsies are collected to support biomarker assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kiran Super Multi-Speciality Hospital
  Surat, Gujarat, India Recruiting
• Oncoville Cancer Hospital and Research Center
  Bangalore, Karnataka, India Recruiting
• Tata Memorial Center
  Mumbai, Maharashtra, India Recruiting
• HCG Manavata Cancer Centre
  Nashik, Maharashtra, India Recruiting
• SunAct Cancer Institute Pvt Ltd
  Thane, Maharashtra, India Recruiting
• All India Institute of Medical Sciences(AIIMS)
  New Delhi, National Capital Territory of Delhi, India Recruiting

Study contacts

• Study coordinator: Kumar Prabhash
• Email: kprabhash1@gmail.com
• Phone: +919167760576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.