RecruitingPhase 1NCT06513624

ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers

A Phase 1B Investigator Initiated Study To Evaluate The Preliminary Activity, Safety And Tolerability Of ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers.


Sponsor

National University Hospital, Singapore

Enrollment

16 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, single-arm, investigator-initiated study conceived as a dose expansion cohort of the study D3-002, which evaluated ETC-159 in combination with pembrolizumab in solid tumors.


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — ETC-159 (a WNT pathway inhibitor) and pembrolizumab (an immunotherapy) — in women with advanced ovarian cancer that has a specific genetic profile called MSS/pMMR. This cancer type typically does not respond well to immunotherapy alone, and ETC-159 aims to change that. **You may be eligible if...** - You are a woman aged 21 or older (at Singapore sites) - You have confirmed advanced or metastatic ovarian cancer - Your tumor has been tested and found to be MSS/pMMR (microsatellite stable) - Your disease progressed after platinum-based chemotherapy within 6 months, or platinum treatment is no longer an option - You have measurable disease on imaging - Your physical performance is adequate **You may NOT be eligible if...** - You have active autoimmune disease requiring systemic treatment - You have had prior treatment with ETC-159 or other WNT pathway inhibitors - You have bone conditions such as osteoporosis that make this study unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGETC-159

ETC-159 will be administered orally.

DRUGPembrolizumab

Pembrolizumab will be administered intravenously.

DRUGDenosumab / Zoledronic Acid

Denosumab will be administrated subcutaneously. Zoledronic Acid will be administered intravenously if denosumab has no response.


Locations(2)

National Cancer Centre Singapore

Singapore, Singapore, Singapore

National University Hospital

Singapore, Singapore

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NCT06513624