ERAS-0015 for Cancer

(AURORAS-1 Trial)

Overseen By Erasca Clinical Team Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Erasca, Inc.

Must not be taking: RAS inhibitors

Disqualifiers: CNS tumors, Gastrointestinal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments.

Eligibility Criteria

This trial is for patients with advanced or metastatic solid tumors that have specific RAS mutations. Participants must not have standard treatment options available, or such treatments are intolerable, ineffective, or refused by the patient. They should be able to perform daily activities (ECOG PS of 0 or 1), swallow pills, and have good heart, blood, liver, and kidney function.

Inclusion Criteria

My cancer type and mutation have been confirmed by lab tests.

I can take pills by mouth.

I am willing and able to sign a consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Optimization

Dose optimization of ERAS-0015 monotherapy and in combination with other cancer therapies

3 weeks

Multiple visits for dose escalation and monitoring

Pharmacokinetics and Pharmacodynamics Assessment

Assessment of pharmacokinetics and pharmacodynamics of ERAS-0015

9 weeks

Regular visits for blood sampling and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Periodic assessments up to 24 months

Treatment Details

Interventions

• ERAS-0015

Trial Overview The study is testing ERAS-0015's safety and tolerability in patients with certain tumor types and mutations. ERAS-0015 will be administered alone or alongside other therapies to see how well it works against these advanced cancers.

Participant Groups

Group I: ERAS-0015 Monotherapy Dose Optimization. Experimental Treatment 1 Intervention

Escalating doses of ERAS-0015 administered orally.

Group II: ERAS-0015 Combination Dose Optimization Experimental Treatment 1 Intervention

ERAS-0015 administered orally with another investigational agent.

Who Is Running the Clinical Trial?

Erasca, Inc.

Lead Sponsor

Trials

8

Recruited

1,200+