A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer (NCT06678659) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
United States, Canada170 participantsStarted 2024-11-21
Plain-language summary
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma
* Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.
* Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥70.
* Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)
Exclusion Criteria:
* Received treatment with another RBM39 degrader
* Clinically significant gastrointestinal (GI) or GI malabsorption
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Initiation of study drug through 4 weeks
2
Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event
Timeframe: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)
3
Phase 2- Objective Response Rate (ORR)
Timeframe: Initiation from study drug until disease progression (up to approximately 24 months)