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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2027-01-30

Brief Summary

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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.

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Detailed Description

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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 as monotherapy and in combination with the autophagy inhibitor hydroxychloroquine (HCQ).

Conditions

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Advanced Malignant Solid Neoplasm RAS Mutation Lung Cancer Colon Cancer Glioblastoma Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RSC-1255 Treatment

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

Group Type EXPERIMENTAL

RSC-1255 Dose Escalation

Intervention Type 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.

RSC-1255 Dose Expansion

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Phase 1a Dose Escalation Phase 1b Dose Expansion

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No