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 : October 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Estimated Enrollment : | 134 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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Experimental: RSC-1255 Treatment
Single Arm Study. All study participants receive RSC-1255.
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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.
Other Names:
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.
Other Names:
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- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Key Factors):
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Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Participant is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
- Malignancy has progressed on standard therapy
- Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
- Is age ≥ 18 years.
Exclusion Criteria (Key Factors):
- Participants receiving cancer therapy at the time of enrollment.
- Any clinically significant disease or condition affecting a major organ system.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
- Known Gilbert's disease.
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer.
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) 644-9818 | clinicaltrials@rascaltherapeutics.com |
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 | 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. |
Responsible Party: | RasCal Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04678648 |
Other Study ID Numbers: |
RSC-101 |
First Posted: | December 22, 2020 Key Record Dates |
Last Update Posted: | October 25, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Malignancy Cancer Refractory RAS mutation Lung |
Colon Glioblastoma RSC-1255 Progression Pancreatic |
Neoplasms Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |