A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
RasCal Therapeutics, Inc.
Study ID
NCT04678648
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RSC-1255 Dose Escalation — DRUG
    Phase 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 — DRUG
    Phase 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.

Study Details

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.

Key Dates

Start date
Mar 3, 2021
Status verified
Mar 2026
Primary completion
Dec 15, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: RSC-1255 Treatment
    Single Arm Study. All study participants receive RSC-1255.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy [ Time Frame: Approximately 30 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles (UCLA) Department of Medicine - Hematology/OncologyLos AngelesCalifornia90404-
Sarah Cannon, SCRI Oncology Partners - Health OneDenverColorado80218-
Sarah Cannon, SCRI Oncology PartnersNashvilleTennessee37203-

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By research site
University of California, Los Angeles (UCLA) Department of Medicine - Hematology/Oncology· Los Angeles, CASarah Cannon, SCRI Oncology Partners - Health One· Denver, COSarah Cannon, SCRI Oncology Partners· Nashville, TN

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