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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04678648
• Other study ID #: RSC-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 16, 2021
• Est. completion date: March 5, 2024

Study information

• Verified date: October 2022
• Source: RasCal Therapeutics, Inc.
• Contact: Bonnie Wettersten, MS
• Phone: (847) 644-9818
• Email: clinicaltrials[@]rascaltherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: March 5, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignant Solid Neoplasm
• Colon Cancer
• Glioblastoma
• Lung Cancer
• Neoplasms
• Pancreatic Cancer
• RAS Mutation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Anschutz Cancer Pavilion - University of Colorado Hospital	Aurora	Colorado
United States	Sarah Cannon Research Institute - Health One	Denver	Colorado
United States	University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology	Los Angeles	California
United States	Sarah Cannon Tennessee Oncology	Nashville	Tennessee
United States	Sidney Kimmel Cancer Center - Thomas Jefferson Hospital	Philadelphia	Pennsylvania
United States	UC Davis Comprehensive Cancer Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
RasCal Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	Approximately 12 months
Primary	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 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.	Approximately 12 months
Secondary	Adverse event profile of RSC-1255	Toxicities will be graded according to CTCAE V5.0.	Approximately 24 months
Secondary	Overall Survival (OS)	Overall Survival will be assessed using RECIST V1.1.	Approximately 24 months