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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a | Experimental | Dose Finding |
|
| Phase 1b Cohort A | Experimental |
| |
| Phase 1b Cohort B | Experimental |
| |
| Phase 1b Cohort C | Experimental |
| |
| Phase 1b Cohort D | Experimental |
| |
| Phase 2 Cohort 1 Dose #1 | Experimental |
| |
| Phase 2 Cohort 1 Dose #2 | Experimental |
| |
| Phase 2 Cohort 2 Dose #1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REC-1245 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs) | To characterize the incidence of DLTs | Initiation of study drug through 4 weeks |
| Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event | To characterize the incidence of treatment emergent adverse events | Initiation of study drug through 30 days after the last dose (up to approximately 24 months) |
| Phase 2- Objective Response Rate (ORR) | To assess tumor response | Initiation from study drug until disease progression (up to approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1- ORR | To assess tumor response | Initiation from study drug until disease progression (up to approximately 24 months) |
| Phase 1 and 2- Disease Control Rate (DCR) | To assess the anti-tumor activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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"Phase 1a: Dose Finding; Phase 1b: Dose Expansion; Phase 2: Randomized"
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|
| Phase 2 Cohort 2 Dose #2 | Experimental |
|
| Initiation from study drug until disease progression as applicable (up to approximately 24 months) |
| Phase 1 and 2 - Duration of Response (DOR) | To assess the anti-tumor activity | Initiation from study drug until disease progression as applicable (up to approximately 24 months) |
| Phase 1 and 2 - Duration of Stable Disease (SD) | To assess the anti-tumor activity | Initiation from study drug until disease progression as applicable (up to approximately 24 months) |
| Phase 1 and 2 - Time to Response (TTR) | To assess the anti-tumor activity | Initiation from study drug until disease progression as applicable (up to approximately 24 months) |
| Phase 1 and 2 - Progression Free Survival (PFS) | To assess the anti-tumor activity | Initiation from study drug until disease progression as applicable (up to approximately 24 months) |
| Phase 1 and 2 - Overall Survival (OS) | To assess the anti-tumor activity | Initiation from study drug until disease progression as applicable (up to approximately 24 months) |
| Phase 1 - Maximum Plasma Concentration (Cmax) | To characterize PK of REC-1245 | Initiation of study drug through Week 9 |
| Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax) | To characterize PK of REC-1245 | Initiation of study drug through Week 9 |
| Phase 1 - Plasma Concentration Before the Next Dose (Ctrough) | To characterize PK of REC-1245 | Initiation of study drug through Week 9 |
| Phase 1 - Area Under Plasma Concentration-time Curve (AUC) | To characterize PK of REC-1245 | Initiation of study drug through Week 9 |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| SCRI Oncology Partners - PPDS | Withdrawn | Nashville | Tennessee | 37203 | United States |
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
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| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 1X6 | Canada |
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| McGill University Health Centre (MUHC) - The Montreal | Recruiting | Québec | H4A3J1 | Canada |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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