Recruiting
Phase 1

RSC-1255

Sponsor:

RasCal Therapeutics, Inc.

Code:

NCT04678648

Conditions

Advanced Malignant Solid Neoplasm

RAS Mutation

Lung Cancer

Colon Cancer

Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RSC-1255 Dose Escalation

RSC-1255 Dose Expansion

Study Details

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.

Conditions

Advanced Malignant Solid Neoplasm

RAS Mutation

Lung Cancer

Colon Cancer

Glioblastoma

Study ID

NCT04678648

Start date

Mar 3, 2021

Status verified date

Jun, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
5. Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS

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.
6. Intermittent hypokalemia
7. Grade 1 or higher nausea, vomiting, diarrhea at baseline due to underlying disease

Study Design

Enrollment

134 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RSC-1255 Treatment

Single Arm Study. All study participants receive RSC-1255.

Interventions

RSC-1255 Dose Escalation

Phase 1a will enroll 40-80 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, with and without food. Each cycle is 21 days.

RSC-1255 Dose Expansion

Phase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days.

Primary outcome measure

  • Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy [ Time Frame: Approximately 30 months ]
  • Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy [ Time Frame: Approximately 12 months ]

Central Contacts and Locations

Locations

University of California, Los Angeles (UCLA) Department of Medicine - Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90404

Sarah Cannon, SCRI Oncology Partners - Health One

Recruiting

Denver, Colorado, United States, 80218

Sarah Cannon, SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

RasCal Therapeutics, Inc.

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Malignancy
  • Cancer
  • Refractory
  • RAS mutation
  • Lung
  • Colon
  • Glioblastoma
  • RSC-1255
  • Progression
  • Pancreatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RasCal Therapeutics, Inc. on 2026-06-23.