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

NCT04678648 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RSC-101
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 3

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; Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 21 days of treatment and maximum grade of all treatment-related events using CTCAE V5.0 will be used to identify a safe and tolerable dose.

  Approximately 30 months

• 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 21 days of treatment and 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 Outcomes (3)

• Adverse event profile of RSC-1255

  Approximately 24 months

• Overall Survival (OS)

  Approximately 24 months

• Disease Progression

  Approximately 24 months

Study Arms (1)

RSC-1255 Treatment

EXPERIMENTAL

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

Drug: RSC-1255 Dose Escalation; Drug: RSC-1255 Dose Expansion

Interventions

RSC-1255 Dose Escalation DRUG

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.

Also known as: Phase 1a, Dose Escalation

RSC-1255 Treatment

RSC-1255 Dose Expansion DRUG

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.

Also known as: Phase 1b, Dose Expansion

RSC-1255 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RasCal Therapeutics, Inc.: lead

Study Sites (3)

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

Los Angeles, California, 90404, United States

RECRUITING

Sarah Cannon, SCRI Oncology Partners - Health One

Denver, Colorado, 80218, United States

RECRUITING

Sarah Cannon, SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Colonic Neoplasms; Glioblastoma; Pancreatic Neoplasms; Neoplasms; Disease Progression

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Mann, MD

  RasCal Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Bonnie Wettersten, MS

CONTACT

(847) 644-9818; clinicaltrials@rascaltherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 22, 2020
• Study Start: March 3, 2021
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)