A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorRecursion Pharmaceuticals Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Received treatment with another RBM39 degrader
Clinically significant gastrointestinal (GI) or GI malabsorption
Trial design
Design model
Sequential
Treatments tested in this trial
REC-1245
DrugOral
Treatment groups
170 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Phase 1aExperimental treatment 1 intervention
Group B: Phase 1b Cohort AExperimental treatment 1 intervention
Group C: Phase 1b Cohort BExperimental treatment 1 intervention
Group D: Phase 1b Cohort CExperimental treatment 1 intervention
Group E: Phase 1b Cohort DExperimental treatment 1 intervention
Group F: Phase 2 Cohort 1 Dose #1Experimental treatment 1 intervention
Group G: Phase 2 Cohort 1 Dose #2Experimental treatment 1 intervention
Group H: Phase 2 Cohort 2 Dose #1Experimental treatment 1 intervention
Group I: Phase 2 Cohort 2 Dose #2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)
To characterize the incidence of DLTs
Time frame
Initiation of study drug through 4 weeks2
Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event
To characterize the incidence of treatment emergent adverse events
Time frame
Initiation of study drug through 30 days after the last dose (up to approximately 24 months)3
Phase 2- Objective Response Rate (ORR)
To assess tumor response
Time frame
Initiation from study drug until disease progression (up to approximately 24 months)Secondary outcomes
1
Phase 1- ORR
To assess tumor response
Time frame
Initiation from study drug until disease progression (up to approximately 24 months)2
Phase 1 and 2- Disease Control Rate (DCR)
To assess the anti-tumor activity
Time frame
Initiation from study drug until disease progression as applicable (up to approximately 24 months)3
Phase 1 and 2 - Duration of Response (DOR)
To assess the anti-tumor activity
Time frame
Initiation from study drug until disease progression as applicable (up to approximately 24 months)4
Phase 1 and 2 - Duration of Stable Disease (SD)
To assess the anti-tumor activity
Time frame
Initiation from study drug until disease progression as applicable (up to approximately 24 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov