A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT04678648|
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : September 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm RAS Mutation Lung Cancer Colon Cancer Glioblastoma Pancreatic Cancer||Drug: RSC-1255 Dose Escalation Drug: RSC-1255 Dose Expansion||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 in Patients With Advanced Solid Tumor Malignancies|
|Actual Study Start Date :||February 16, 2021|
|Estimated Primary Completion Date :||January 16, 2024|
|Estimated Study Completion Date :||March 5, 2024|
Experimental: RSC-1255 Treatment
Single Arm Study. All study participants receive RSC-1255.
Drug: RSC-1255 Dose Escalation
Phase 1a will enroll 24-34 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.
Drug: RSC-1255 Dose Expansion
Phase 1b will enroll 48-104 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.
- Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy [ Time Frame: Approximately 12 months ]The number and type of dose-limiting toxicities (DLTs) as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all maximum grade of all treatment-related events using CTCAE V5.0 will be used to identify a safe and tolerable dose.
- Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy [ Time Frame: Approximately 12 months ]The number and type of DLTs as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE 5.0 will be used to identify a safe and tolerable dose.
- Adverse event profile of RSC-1255 [ Time Frame: Approximately 24 months ]Toxicities will be graded according to CTCAE V5.0.
- Overall Survival (OS) [ Time Frame: Approximately 24 months ]Overall Survival will be assessed using RECIST V1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678648
|Contact: Bonnie Wettersten, MS||(847) firstname.lastname@example.org|
|United States, California|
|University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology||Recruiting|
|Los Angeles, California, United States, 90404|
|UC Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|United States, Colorado|
|Anschutz Cancer Pavilion - University of Colorado Hospital||Not yet recruiting|
|Aurora, Colorado, United States, 80045|
|Sarah Cannon Research Institute - Health One||Recruiting|
|Denver, Colorado, United States, 80218|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center - Thomas Jefferson Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Tennessee|
|Sarah Cannon Tennessee Oncology||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Robert Reder, MD||RasCal Therapeutics, Inc.|