JBI-802 for Solid Tumors

Recruiting at 1 trial location

Overseen By Director, Program Management

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jubilant Therapeutics Inc.

Must not be taking: CYP3A inhibitors, CYP3A inducers, CYP2D6 inhibitors, CYP2D6 inducers

Disqualifiers: CNS disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

126 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid Tumors.The efficacy of the RP2D will be evaluated in phase 2 in patients with solid tumors of neuroendocrine differentiation.

Will I have to stop taking my current medications?

The trial requires you to stop using strong inhibitors or inducers of certain enzymes (CYP3A and CYP2D6) at least 14 days before starting the study. If you're on anticoagulants, you must be on a stable dose for at least 2 weeks before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Research Team

Program Manager

Principal Investigator

Jubilant Therapeutics Inc.

Eligibility Criteria

Adults with advanced solid tumors that can't be surgically removed or have spread, and who lack effective treatment options. They must have a certain level of organ function and no severe medical conditions or recent use of specific drugs that affect metabolism.

Inclusion Criteria

Absolute neutrophil count (ANC) ≥1500 cells/mm3

Platelet count ≥100,000 cells/mm3

Total bilirubin ≤1.5×ULN. Patients with Gilbert's syndrome may be enrolled with up to 3.0xULN

Exclusion Criteria

I haven't taken strong CYP2D6 inducers recently.

My brain metastases are stable and I haven't taken steroids for them in the last 14 days.

I have had surgery or a condition that affects how my body absorbs medicine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of JBI-802 to determine the maximum-tolerated dose (MTD)

4-8 weeks

Weekly visits (in-person)

Dose Expansion

Participants receive the recommended Phase 2 dose (RP2D) to evaluate efficacy in specific cancer types

Up to 30 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days from the last dose

Treatment Details

Interventions

• JBI-802

Trial Overview The trial is testing JBI-802, an oral drug for advanced solid tumors. It aims to find the highest dose patients can take without serious side effects (MTD) and the optimal dose for further studies (RP2D). Phase 2 will assess its effectiveness in certain tumor types.

Participant Groups

Group I: JBI-802 Experimental Treatment 1 Intervention

10 mg JBI-802 once daily as the starting dose with 4 days on/3 days off cycle

Who Is Running the Clinical Trial?

Jubilant Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

130+