Actively Recruiting
A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
Led by Recursion Pharmaceuticals Inc. · Updated on 2026-05-08
170
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating REC-1245, an oral drug, in participants aged 12 and older with unresectable, locally advanced, or metastatic solid tumors, including some relapsed or refractory lymphomas. This open-label, multi-center study aims to assess the safety, tolerability, how the drug is processed in the body (pharmacokinetics), and preliminary activity of REC-1245. The study includes both Phase 1 and Phase 2 portions, focusing on identifying appropriate dosing and measuring treatment effects over time. Participants will receive REC-1245 once daily by mouth for up to two years. The study has several groups, including dose-finding and multiple cohorts in Phase 1b and Phase 2, each receiving experimental doses of REC-1245. There is no use of placebo or blinding, and the treatment schedule is designed to monitor responses and side effects closely throughout the study duration. During the study, participants will undergo regular assessments including imaging scans like CT or MRI to measure tumor size, and evaluations of side effects from the start of treatment until up to 30 days after the last dose. Researchers will track key outcomes such as dose limiting toxicities, adverse events, and tumor responses over the treatment period of up to approximately 24 months. Safety and drug levels in the blood will be monitored intensively in early phases to guide dosing and evaluate tolerability.
CONDITIONS
Brief Title
A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3C=1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of �3E=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)
You will not qualify if you...
- Received treatment with another RBM39 degrader
- Clinically significant gastrointestinal (GI) or GI malabsorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive the study drug REC-1245 orally for the treatment of unresectable, locally advanced, or metastatic cancer.
Visits occur regularly during treatment to monitor safety and response
Trial Site Locations
Total: 6 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
SCRI Oncology Partners - PPDS
Nashville, Tennessee, United States, 37203
Withdrawn
4
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
5
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
6
McGill University Health Centre (MUHC) - The Montreal
Québec, Canada, H4A3J1
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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