FHD-286 for Blood Cancers

Recruiting at 5 trial locations

Overseen By Foghorn Clinical Trials

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Foghorn Therapeutics Inc.

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

Disqualifiers: Active infections, Uncontrolled illness, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects with advanced hematologic malignancies.

Will I have to stop taking my current medications?

The trial requires stopping certain medications, such as strong CYP3A inhibitors and inducers, and medications with narrow therapeutic indexes that are sensitive P-gp or BCRP substrates. Proton pump inhibitors should be stopped or switched 7 days before starting the trial. Some medications may be allowed with sponsor approval.

Research Team

Sarah Reilly, MD

Principal Investigator

Foghorn Therapeutics

Eligibility Criteria

Adults with advanced blood cancers like myelodysplastic syndrome or acute myeloid leukemia can join this trial. They must be able to consent, follow the study plan, and have a life expectancy of at least 3 months. Key organ functions need to be stable, and they should not consume certain foods or supplements that affect specific enzymes. Women must not be pregnant or breastfeeding, and men agree to use contraception.

Inclusion Criteria

I am a woman who is either postmenopausal, cannot have children, or am not pregnant and not breastfeeding.

I have been diagnosed with an advanced blood cancer.

Subject must be able to understand and be willing to sign an informed consent

Exclusion Criteria

I am currently being treated for a severe infection.

I have a serious illness that is not under control.

Subject has any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Successive cohorts of participants receive increasing oral doses of FHD-286 as monotherapy or in combination with LDAC or decitabine to determine the RP2D(s)

8-12 weeks

Treatment

Participants receive FHD-286 orally as monotherapy or in combination with LDAC or decitabine

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FHD-286

Trial Overview The trial is testing FHD-286 alone or with other drugs (Low Dose Cytarabine/Decitabine) in patients with serious blood disorders. It's an early-phase study looking at safety, how well the body handles the drug (PK/PD), and its initial effectiveness against cancer.

Participant Groups

Group I: FHD-286 in Combination with LDAC Experimental Treatment 2 Interventions

FHD-286 administered orally + LDAC administered subcutaneously

Group II: FHD-286 in Combination with Decitabine Experimental Treatment 2 Interventions

FHD-286 administered orally + decitabine administered intravenously (IV)

Group III: FHD-286 Monotherapy Experimental Treatment 1 Intervention

Closed to Enrollment

Who Is Running the Clinical Trial?

Foghorn Therapeutics Inc.

Lead Sponsor

Trials

3

Recruited

280+