126 Participants Needed

JBI-802 for Solid Tumors

Recruiting at 1 trial location
CS
DP
Overseen ByDirector, Program Management
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

PM

Program Manager

Principal Investigator

Jubilant Therapeutics Inc.

Are You a Good Fit for This Trial?

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
See 9 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: JBI-802Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jubilant Therapeutics Inc.

Lead Sponsor

Trials
1
Recruited
130+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security