Clinical trial NCT04678648: A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Malignant Solid Neoplasm
RAS Mutation
Lung Cancer
Colon Cancer
Glioblastoma
Pancreatic Cancer
Keywords: Malignancy
Cancer
Refractory
RAS mutation
Lung
Colon
Glioblastoma
RSC-1255
Progression
Pancreatic
Lead sponsor: RasCal Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: RSC-1255 is an orally bioavailable, small-molecule direct pan-mutant and wild-type RAS inhibitor. RSC-101 is a Phase 1a/1b, open-label, multi-center, non-randomized, Dose Escalation and Dose Expansion study in participants with advanced solid tumor malignancies. Study enrollment is approximately 134 participants. All participants receive oral RSC-1255, twice daily as monotherapy. Following Phase 1a (Dose Escalation) to identify the Maximum Tolerated Dose and Recommended Dose for use in Phase 1b, additional participants are enrolled in the Phase 1b (Dose Expansion) to further characterize the safety, pharmacology, and the clinical efficacy of RSC-1255.

Eligibility criteria: Inclusion Criteria (Key Factors):

1. 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
2. Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
3. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
4. Is age ≥ 18 years.

Exclusion Criteria (Key Factors):

1. Participants receiving cancer therapy at the time of enrollment.
2. Any clinically significant disease or condition affecting a major organ system.
3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
4. Known Gilbert's disease.
5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
timeFrame: Approximately 30 months
measure: Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Adverse event profile of RSC-1255
timeFrame: Approximately 24 months
measure: Overall Survival (OS)
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
state: California
city: Denver
country: United States
facility: Sarah Cannon, SCRI Oncology Partners - Health One
state: Colorado
city: Nashville
country: United States
facility: Sarah Cannon, SCRI Oncology Partners
state: Tennessee
Study officials:
affiliation: RasCal Therapeutics, Inc.
name: Pamela Munster, MD
role: STUDY_DIRECTOR
References: