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

  • STATUS
    Recruiting
  • End date
    Mar 5, 2024
  • participants needed
    134
  • sponsor
    RasCal Therapeutics, Inc.
Updated on 22 March 2022
solid tumor

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.

Details
Condition Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer, Colon Cancer, Glioblastoma, Pancreatic Cancer
Treatment RSC-1255 Dose Escalation, RSC-1255 Dose Expansion
Clinical Study IdentifierNCT04678648
SponsorRasCal Therapeutics, Inc.
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG)
and/or laboratory assessments as applicable to their malignancy
Is age ≥ 18 years

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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