Clinical trial NCT06678659: A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
Official title: A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer (DAHLIA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Unresectable
Locally Advanced
Metastatic Cancers
Relapsed/Refractory Lymphomas
Keywords: RBM39
Cancer
Refractory Lymphomas
Metastatic Cancers
Lead sponsor: Recursion Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: "Phase 1a: Dose Escalation Phase 1b: Randomized Phase 2: Non-Randomized"
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label study to investigate the safety, tolerability, PK, 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: Approximately 85 individuals will be enrolled in this open-label Phase 1/2 study, allocated 55 individuals in Phase 1 and 10-30 individual's in Phase 2. 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older 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.

ECOG performance status ≤ 1 Measurable disease at baseline per RECIST 1.1 / Lugano criteria and documented by computed CT and / or MRI

Exclusion Criteria:

* Received treatment with another RBM39 degrader Clinically significant gastrointestinal (GI) or GI malabsorption

Primary outcomes:
measure: Phase 1-Part 1A [Dose Finding]- Assessment of Dose limiting toxicities [DLTs]
timeFrame: Initiation of study drug through 4 weeks
measure: Phase 1/2 -Treatment emergent adverse events
timeFrame: Initiation of study drug through 30 days after the last dose [up to approximately 24 months]
measure: Phase 2- Objective Response Rate [ORR]
timeFrame: Initiation from study drug until disease progression [up to approximately 24 months]
Secondary outcomes:
measure: Phase 1- Objective Response Rate [ORR]
timeFrame: Initiation from study drug until disease progression [up to approximately 24 months]
measure: Phase 2- Disease control rate (DCR)
timeFrame: Initiation from study drug until disease progression as applicable [up to approximately 24 months]
measure: Phase 2 - Duration of response (DOR)
timeFrame: Initiation from study drug until disease progression as applicable [up to approximately 24 months]
measure: Phase 2 - Duration of SD
timeFrame: Initiation from study drug until disease progression as applicable [up to approximately 24 months]
measure: Phase 2 - Time to Response (TTR)
timeFrame: Initiation from study drug until disease progression as applicable [up to approximately 24 months]
measure: Phase 2 - Progression free survival (PFS)
timeFrame: Initiation from study drug until disease progression as applicable [up to approximately 24 months]
measure: Phase 2 - Overall Survival (OS)
timeFrame: Initiation from study drug until disease progression as applicable [up to approximately 24 months]
measure: Phase 1/2 - maximum plasma concentration (Cmax)
timeFrame: Initiation of study drug through Week 9
measure: Phase 1/2 - time to reach maximum plasma concentration (Tmax)
timeFrame: Initiation of study drug through Week 9
measure: Phase 1/2 - plasma concentration before the next dose (Ctrough) and Area under plasma concentration-time c
timeFrame: Initiation of study drug through Week 9
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: SCRI Oncology Partners - PPDS
state: Tennessee
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
Study officials:
References: