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

NCT07755397 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: JBI-778_101CTRI/2024/07/070802
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

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 is reached, whichever comes first as determined by the safety committee will be performed only in EGFR mutant NSCLC patients with or without stable cerebral metastases and ACC patients. Once this dose level is reached IDH mutant WHO grade 3 /4 glioma patients will be added. Once the RP2D is determined following dose escalation, additional patients, up to 12, will be treated at that dose to obtain further safety data and preliminary efficacy. Approximately 4 to 6 sites are anticipated for the dose-escalation/consolidation, additional sites will be evaluated as needed. Study will be initiated only after receipt of regulatory and ethics committee (EC) approval. After signing the informed consent form, the patients will undergo screening assessments to confirm eligibility. Eligible patients will be considered first for initial dose escalation and once the RP2D is determined following dose escalation, additional patients, up to 12, will be treated at that dose to obtain further safety data and preliminary efficacy. The RP2D will be establish after a detailed analysis of the totality of dose escalation data, including PK, safety, efficacy, CNS penetration based on CSF sample for study drug presence, analysis of PD markers in peripheral blood and both pre-treatment and on treatment tumor biopsies. The duration of participation for each patient will be as follows: Screening: - Up to 21 days (-21 to 1 days); Treatment period: Treatment cycle of 21-day each. Treatment may continue for up to 2 years from the start of treatment, provided that the patient experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of the disease, unacceptable toxicity, or other reasons for study discontinuation. End of treatment (EOT)/ Early termination (ET) visit Safety Follow-up: 30 days after last dose Survival: Every 3 months

Conditions

NSCLC Patients With EGFR Activating Mutation; Adenoid Cystic Carcinoma Metastatic; Adenoid Cystic Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicities (DLTs)

  Incidence of dose-limiting toxicities during the DLT evaluation period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-778.

  At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Up to 2 years

• Maximum Plasma Concentration (Cmax) of JBI-778

  From Cycle 1 Day 1 up to Cycle 2 Day 1 (each cycle is 21 days)

• Area Under the Plasma Concentration-Time Curve (AUC0-t) of JBI-778

  From Cycle 1 Day 1 up to Cycle 2 Day 1 (each cycle is 21 days)

• Time to Maximum Plasma Concentration (Tmax) of JBI-802

  From Cycle 1 Day 1 up to Cycle 2 Day 1 (each cycle is 21 days)

• Progression-Free Survival (PFS)

  up to 2years

Study Arms (1)

JBI-778 Dose Escalation

EXPERIMENTAL

Participants will receive orally administered JBI-778 once daily in continuous 21-day treatment cycles. Dose escalation will follow a 3+3 design beginning at 40 mg daily to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Additional participants may be enrolled at the RP2D to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.

Drug: JBI-778

Interventions

JBI-778 DRUG

JBI-778 is an orally administered selective PRMT5 inhibitor supplied as capsules. The starting dose is 40 mg once daily. Participants will receive JBI-778 in continuous 21-day treatment cycles with dose escalation based on a 3+3 design. Capsules are taken orally with water approximately 1 hour before a meal or 2 hours after a meal.

JBI-778 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adenoid cystic carcinoma (ACC) with recurrent, metastatic, or advanced incurable disease.
• At least one measurable lesion according to RECIST v1.1 and/or RANO criteria, as applicable.
• ECOG performance status ≤2.
• Adequate hematologic, hepatic, renal, and coagulation function.
• Resolution of clinically significant toxicities from prior therapy to Grade 0 or 1, except permitted residual toxicities.
• Life expectancy of at least 3 months.
• Able to swallow oral medication.
• Availability of tumor tissue and/or liquid biopsy suitable for next-generation sequencing.
• Willing to use highly effective contraception during study participation and for at least 3 months after the last dose of study treatment.
• Able and willing to provide written informed consent.

You may not qualify if:

• Systemic anticancer therapy or investigational therapy within 2 weeks or 5 half-lives prior to study treatment.
• Major surgery within 21 days before study treatment.
• Radiotherapy within 4 weeks for brain metastases or within 2 weeks for other disease sites.
• Significant uncontrolled cardiovascular, metabolic, psychiatric, or other serious medical conditions.
• QTcF \>450 msec in males or \>470 msec in females.
• History of optic neuritis or optic neuropathy.
• Active HIV infection or active hepatitis B or C infection.
• Active infection requiring systemic antibiotic therapy.
• Use of strong CYP3A inhibitors or inducers within protocol-specified washout periods.
• Gastrointestinal conditions that may significantly affect drug absorption.
• Pregnancy or breastfeeding.
• Participation in another interventional clinical study.
• Previous treatment with JBI-778.
• Any condition that, in the opinion of the investigator, would place the participant at unacceptable risk or interfere with study participation.

Sponsors & Collaborators

• Jubilant Therapeutics India Limited: lead

Study Sites (6)

Kiran Super Multi-Speciality Hospital

Surat, Gujarat, 395004, India

RECRUITING

Oncoville Cancer Hospital and Research Center

Bangalore, Karnataka, 560072, India

RECRUITING

Tata Memorial Center

Mumbai, Maharashtra, 400012, India

RECRUITING

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

RECRUITING

SunAct Cancer Institute Pvt Ltd

Thane, Maharashtra, 400615, India

RECRUITING

All India Institute of Medical Sciences(AIIMS)

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Central Study Contacts

Kumar Prabhash

CONTACT

+919167760576; kprabhash1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: August 26, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

IN (6)