trialsTrialRecruiting

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

A phase 1/2 trial of Fulvestrant in advanced solid tumours, run by Ensem Therapeutics, now recruiting.

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06993844 by Ensem Therapeutics, with 233 participants planned, started 2025-06-10 and due to reach its primary completion in 2027-06-30. Interventions recorded: ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant and ETX-636 dose expansion in combination with fulvestrant.

Setting

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Phase

Phase 1/2

Sponsor

Ensem Therapeutics

Registry

Enrolled

233

Connected

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cancers

1

Metastatic cancer (cancer that has spread)

drugs

1

ApprovedInjectable SERD

Fulvestrant · Faslodex

Evidence strength25/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
233 enrolled+12
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Sources & links

ClinicalTrials.gov NCT06993844

Tags

pipeline

Data

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Cancers

Metastatic cancer (cancer that has spread)

Products

Fulvestrant