Open Actively Recruiting

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 I

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.

Join this Trial

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Study Stats
Protocol No.
20-002183
Category
Hematology-Oncology
Oncology
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04678648
For detailed technical eligibility, visit ClinicalTrials.gov.