200 Participants Needed

ERAS-0015 for Cancer

(AURORAS-1 Trial)

Recruiting at 4 trial locations
EC
Overseen ByErasca Clinical Team Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ERAS-0015, to determine its safety and tolerability in individuals with advanced or spreading solid tumors, particularly those with specific RAS mutations. The trial examines ERAS-0015 both as a standalone treatment and in combination with other therapies. It suits patients who have exhausted all available treatments without success or cannot access or tolerate standard treatments. Participants must have tumors with specific mutations and be able to swallow pills. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ERAS-0015 is being tested for safety in patients with advanced or spreading solid tumors. In early studies using ERAS-0015 alone, researchers aim to find the highest safe dose. They monitor patient tolerance and watch for side effects.

In combination therapy, ERAS-0015 is paired with another experimental drug to assess safety and patient tolerance. As these are early trials, the primary focus remains on safety and determining the optimal dose.

Since ERAS-0015 is in an early testing phase, detailed safety information is still being collected. This ongoing review will enhance understanding of patient tolerance based on trial data.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ERAS-0015 because it offers a fresh approach to cancer treatment. Unlike traditional therapies that often target cancer cells broadly, ERAS-0015 works by precisely targeting specific pathways involved in cancer growth. This targeted mechanism could potentially lead to more effective and less toxic treatments. Additionally, ERAS-0015 is taken orally, which is a more convenient alternative to intravenous chemotherapy, making it easier for patients to incorporate into their daily lives.

What evidence suggests that ERAS-0015 could be an effective treatment for cancer?

Research has shown that ERAS-0015, a new cancer treatment, delivers promising results in lab studies. It blocks RAS signaling, a process that aids the growth of some cancer cells. In these studies, ERAS-0015 effectively reduced tumors both alone and in combination with other treatments. Participants in this trial will receive ERAS-0015 either as a monotherapy with escalating doses or alongside another investigational agent. The treatment is well absorbed and distributed throughout the body, which is crucial for its effectiveness. These early results suggest that ERAS-0015 could be a strong option for treating certain advanced cancers.16789

Who Is on the Research Team?

GL

Gerri Lee

Principal Investigator

Erasca, Inc.

Are You a Good Fit for This Trial?

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: ERAS-0015 Monotherapy Dose Optimization.Experimental Treatment1 Intervention
Group II: ERAS-0015 Combination Dose OptimizationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Erasca, Inc.

Lead Sponsor

Trials
8
Recruited
1,200+

Citations

News Release DetailsERAS-0015 is an oral, highly potent pan-RAS molecular glue that is designed to inhibit RAS signaling with a potential best-in-class profile.
NCT06983743 | A Study of ERAS-0015 in Patients With ...Study Overview. 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 ...
Erasca Announces Issuance of a U.S. Patent Covering Pan ...In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties ...
Erasca Presents New Preclinical Data Reinforcing Best-in- ...ERAS-0015 and ERAS-4001 showed robust anti-tumor activity as monotherapy and combination therapy. First-in-class examples of direct SHOC2 ...
Erasca, Inc. Advances in Cancer Treatment with ERAS ...The study aims to determine the safety and tolerability of ERAS-0015 in patients with advanced or metastatic solid tumors with specific RAS ...
Erasca Announces Early Clinical Advancement and ...Both ERAS-0015 and ERAS-4001 have the potential to change the ... ERAS-0015: AURORAS-1 Phase 1 monotherapy data (safety, pharmacokinetics, and ...
A Study of ERAS-0015 in Patients With Advanced or ...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 ...
A Study of ERAS-0015 in Patients With Advanced or ...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 ...
Erasca Announces IND Clearance for Potential First-in- ...Both ERAS-4001 and potential best-in-class pan-RAS molecular glue ERAS-0015 received IND clearance in May ahead of company guidance.
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