IDH305 for Advanced Cancer

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Cardiac, Respiratory, Gastrointestinal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days

166 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for patients with advanced cancers that have a specific genetic change called IDH1R132 mutation. They should be relatively active and able to care for themselves (ECOG ≤ 2). It's not open to those who've tried similar IDH1 inhibitors, except if they have glioma, or those with serious heart, lung, stomach, kidney, liver or nerve diseases. Pregnant or breastfeeding women can't join.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My tumor has an IDH1R132 mutation.

Exclusion Criteria

I have been diagnosed with Acute Promyelocytic Leukemia.

I am not pregnant or breastfeeding.

I have been treated with an IDH1 inhibitor before, except if I had a glioma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IDH305 to determine the maximum tolerated dose and assess safety and tolerability

21 days

Follow-up

Participants are monitored for safety, tolerability, and preliminary anti-tumor activity

30 months

Treatment Details

Interventions

• IDH305

Trial Overview The study is testing the safety and effectiveness of a drug named IDH305 on patients whose tumors have the IDH1R132 mutation. This early-phase trial will help determine how well this treatment works and what doses are safe.

Participant Groups

Group I: IDH305 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD