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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria (Key Factors):

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

Exclusion Criteria (Key Factors):

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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