ETX-636 for Cancer

Overseen By Melinda Snyder

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ensem Therapeutics

Disqualifiers: Other cancers, Brain metastases, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

233 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors

Eligibility Criteria

This trial is for adults with advanced solid tumors, including breast cancer, that have a specific mutation (PIK3CA). Participants must have tried other treatments like CDK4/6 inhibitors and anti-estrogen therapy without success. They should be relatively active and well (ECOG score 0 or 1) and have at least one measurable tumor.

Inclusion Criteria

Key

I have at least one tumor that can be measured.

My cancer has spread and cannot be removed by surgery, and it has worsened after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Part A

Participants receive escalating doses of ETX-636 as monotherapy for advanced solid tumors with PIK3CA mutation

28 days per cycle

Treatment Part B

Participants receive escalating doses of ETX-636 in combination with fulvestrant for HR+/HER2- breast cancer

28 days per cycle

Treatment Part C

Combination therapy expansion with ETX-636 and fulvestrant for HR+/HER2- breast cancer

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• ETX-636

Trial Overview The study is testing different doses of ETX-636 alone or in combination with fulvestrant, an existing breast cancer treatment. It's an early-phase trial to see how safe the drug is and how it affects people with certain types of advanced cancers.

Participant Groups

Group I: Part C Dose Expansion Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) Experimental Treatment 1 Intervention

Part B is a dose expansion combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM.

Group II: Part B Dose Escalation Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) Experimental Treatment 1 Intervention

Part B is a dose escalation combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM.

Group III: Part A Dose Escalation Monotherapy (Advanced Solid Tumors with PIK3CA mutation) Experimental Treatment 1 Intervention

Part A is a dose escalation monotherapy of ETX-636 in advanced solid tumors with PIK3CA mutation

Who Is Running the Clinical Trial?

Ensem Therapeutics

Lead Sponsor