. Participant must have progressed on at least one prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care, or for which the participant has documented intolerance
. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)
Exclusion criteria
. Known primary CNS malignancy
. Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
. Have active, uncontrolled infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial that's no longer actively recruiting, is there any chance my doctor could get me access to IDE161 through a compassionate use or expanded access program, or are there similar PARG inhibitor trials still enrolling that might be worth looking into?
2Given that Phase 1 trials are primarily designed to test safety and find the right dose rather than to prove the treatment works, what does my doctor think the realistic risk-to-benefit balance looks like for someone in my situation compared to standard treatment options?
3This trial tested IDE161 both alone and in combination with pembrolizumab, which is an immunotherapy drug — does my doctor know yet which approach showed a more manageable safety profile, and would either combination be relevant to my specific cancer type?
4My cancer type is one of several included in this trial, including breast, ovarian, prostate, endometrial, colorectal, head and neck, and lung cancers — does my doctor know whether the early data from this study showed any signals specific to my tumor type that might inform my treatment decisions now?
5Since the trial is active but no longer recruiting, are there published or preliminary results my doctor can access that might help us understand whether PARG inhibition is a promising direction worth pursuing through other available studies or future trials?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDE
Timeframe: Approximately 2 years
2
Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE
Timeframe: Approximately 4 years
3
Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab