Study of INX-315 for Advanced Breast and Ovarian Cancers
This study is testing a new oral medication called INX-315 for people with advanced breast cancer (specifically, hormone receptor positive and HER2 negative types that have worsened after prior treatment with a CDK4/6 inhibitor) or advanced ovarian cancer (platinum-resistant or refractory, with a specific genetic change called CCNE-1 amplification). Researchers want to understand how safe INX-315 is, how well your body handles it, and if it can help shrink tumors. INX-315 will be given alone or in combination with other drugs like fulvestrant or abemaciclib. The study will look at side effects and how well the treatment works over time, up to 12 months.
- Study design
- This is a Phase 1/2, open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll up to 150 participants.
- What's involved
- Participants will receive INX-315, either alone or with other medications. Dose-limiting toxicities (side effects that are severe enough to limit the dose) will be assessed during the first 28 days of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will evaluate side effects and laboratory changes for up to 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
At a glance
Conditions
Where it's being run
18 sites across 12 statesWho to contact
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What this trial measures
- Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities in INX-315 monotherapy and in combination with fulvestrantUp to 12 months
- Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 128 days
- Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phaseUp to 12 months
- Part B: Overall response rate (ORR)Up to 36 months
- Part B: Selection of Recommended Phase 2 Dose (RP2D)Up to 36 months
- Part C Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities for patients in combination treatment (INX_315+abemaciclib+fulvestrant)Up to 12 months
- Part C - Evaluate the antitumor activity of INX-315 in combination with abemaciclib and fulvestrantUp to 12 months