First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor

This is a phase 1, multicentre, first-in-human, open-label, dose-escalation/consolidation study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered JBI-778 in EGFR mutated lung cancer patients with or without brain metastasis, IDH mutated WHO grade 3 /4 recurrent glioma and ACC with evidence of recurrent, metastatic or advanced, incurable disease arising from any primary site. A total of 42 patients will be recruited in the study. The initial dose escalation up to cohort 3 (estimate to be 160mg) or until the pharmacologically active dose

Trial Details

NCT ID
NCT07755397
Phase
PHASE1
Sponsor
Jubilant Therapeutics India Limited
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • JBI-778
Locations (sample)
  • Surat, Gujarat, India|21.19594,72.83023
  • Bangalore, Karnataka, India|12.97194,77.59369
  • Mumbai, Maharashtra, India|19.07283,72.88261
  • Nashik, Maharashtra, India|19.99727,73.79096
  • Thane, Maharashtra, India|19.19704,72.96355

Key Eligibility Criteria

  • Male or female participants aged ≥18 years.
  • Histologically or cytologically confirmed:
  • EGFR-mutated non-small cell lung cancer (NSCLC) with or without brain metastases previously treated with an EGFR inhibitor; or
  • IDH-mutated WHO Grade 3/4 recurrent glioma; or

For full eligibility, visit ClinicalTrials.gov.

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