Locally Advanced, Metastatic Cancers, Relapsed/Refractory Lymphomas, Unresectable
Conditions
Keywords
RBM39, Cancer, Refractory Lymphomas, Metastatic Cancers
Brief 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.
Detailed description
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.
Interventions
DRUGREC-1245
Oral
Sponsors
Recursion Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
"Phase 1a: Dose Finding; Phase 1b: Dose Expansion; Phase 2: Randomized"
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs) | Initiation of study drug through 4 weeks | To characterize the incidence of DLTs |
| Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event | Initiation of study drug through 30 days after the last dose (up to approximately 24 months) | To characterize the incidence of treatment emergent adverse events |
| Phase 2- Objective Response Rate (ORR) | Initiation from study drug until disease progression (up to approximately 24 months) | To assess tumor response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1- ORR | Initiation from study drug until disease progression (up to approximately 24 months) | To assess tumor response |
| Phase 1 and 2- Disease Control Rate (DCR) | Initiation from study drug until disease progression as applicable (up to approximately 24 months) | To assess the anti-tumor activity |
| Phase 1 and 2 - Duration of Response (DOR) | Initiation from study drug until disease progression as applicable (up to approximately 24 months) | To assess the anti-tumor activity |
| Phase 1 and 2 - Duration of Stable Disease (SD) | Initiation from study drug until disease progression as applicable (up to approximately 24 months) | To assess the anti-tumor activity |
| Phase 1 and 2 - Time to Response (TTR) | Initiation from study drug until disease progression as applicable (up to approximately 24 months) | To assess the anti-tumor activity |
| Phase 1 and 2 - Progression Free Survival (PFS) | Initiation from study drug until disease progression as applicable (up to approximately 24 months) | To assess the anti-tumor activity |
| Phase 1 and 2 - Overall Survival (OS) | Initiation from study drug until disease progression as applicable (up to approximately 24 months) | To assess the anti-tumor activity |
| Phase 1 - Maximum Plasma Concentration (Cmax) | Initiation of study drug through Week 9 | To characterize PK of REC-1245 |
| Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax) | Initiation of study drug through Week 9 | To characterize PK of REC-1245 |
| Phase 1 - Plasma Concentration Before the Next Dose (Ctrough) | Initiation of study drug through Week 9 | To characterize PK of REC-1245 |
| Phase 1 - Area Under Plasma Concentration-time Curve (AUC) | Initiation of study drug through Week 9 | To characterize PK of REC-1245 |
Countries
Canada, United States
Outcome results
None listed