RSC-101 is a Phase 1a/1b clinical trial of RSC-1255 in adult study participants with advanced solid tumor malignancies who are intolerant of existing therapies known to provide clinical benefit, have disease that has progressed after standard therapy, or have previously failed other therapies. The study has two phases. The purpose of Phase 1a (Dose Escalation) is to confirm the appropriate treatment dose and Phase 1b (Dose Expansion) is to characterize the safety and efficacy of RSC-1255.
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.
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.
Sequential
RSC-1255 Dose Escalation
DrugPhase 1a will enroll 40-80 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, with and without food. Each cycle is 21 days.
RSC-1255 Dose Expansion
DrugPhase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days.
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
The number and type of dose-limiting toxicities (DLTs) as defined in the protocol that occur during the first 21 days of treatment and 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
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and 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
Toxicities will be graded according to CTCAE V5.0.
Overall Survival (OS)
Overall Survival
Disease Progression
Disease Progression will be assessed using RECIST V1.1
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