ERAS-4001 for Cancer

(BOREALIS-1 Trial)

Recruiting at 4 trial locations

Overseen By Erasca Clinical 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: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called ERAS-4001, an experimental therapy, to determine its safety for individuals with advanced or metastatic solid tumors that have specific KRAS mutations. The treatment will be tested alone and in combination with other new medicines. Suitable candidates have solid tumors with specific mutations and lack other effective standard treatments. Participants must be able to take pills and agree to follow the study rules. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

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?

Earlier research showed that ERAS-4001 had promising results in the lab against certain cancer mutations. This suggests potential effectiveness, but its safety in humans is still under investigation. As a Phase 1 trial, the primary goal is to determine the safety of ERAS-4001 and how the body processes it. Phase 1 trials mark the first time a new treatment is tested in people, so limited safety information is available. Researchers are testing the treatment both alone and with another drug, closely monitoring patient responses to different doses. This will help determine if ERAS-4001 is well-tolerated and identify any potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for cancer, which often includes chemotherapy and radiation, ERAS-4001 is administered orally and features a new mechanism of action. Most cancer treatments work by attacking rapidly dividing cells, but ERAS-4001 is designed to target specific cancer cell pathways, potentially offering a more precise treatment option. Researchers are excited about ERAS-4001 because it can be used both as a standalone treatment and in combination with other investigational agents, providing flexibility in addressing different types of tumors. This targeted approach could minimize side effects and improve outcomes for patients.

What evidence suggests that ERAS-4001 could be an effective treatment for advanced or metastatic solid tumors?

Research shows that ERAS-4001 targets KRAS mutations, which are changes in a gene linked to cancer growth. Early lab studies have demonstrated its strong potential by effectively blocking both active and inactive forms of KRAS, even at very low doses. This suggests it could be quite effective against tumors with these mutations. It did not affect other similar proteins, which might help reduce side effects. In this trial, participants may receive ERAS-4001 as a monotherapy or in combination with another investigational agent. When combined with other treatments, ERAS-4001 aims to increase effectiveness by working alongside existing therapies. Overall, early findings are promising for its use in treating certain advanced cancers. ^{1 2 4 6 7}

Who Is on the Research Team?

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 KRAS mutations. Details on eligibility criteria are not fully provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

Willing and able to give written informed consent

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

No standard treatments work for my cancer, or I can't access or tolerate them.

Exclusion Criteria

Currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-4001

Any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs

Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

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-4001 monotherapy and in combination with other cancer therapies

9 weeks

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• ERAS-4001

Trial Overview

The study is testing the safety and tolerability of a new drug called ERAS-4001 in patients with certain types of cancer. It will be administered alone or alongside other treatments to see how well it works.

How Is the Trial Designed?

Group I: ERAS-4001 Monotherapy Dose Optimization. Experimental Treatment 1 Intervention

Escalating doses of ERAS-4001 administered orally.

Group II: ERAS-4001 Combination Dose Optimization Experimental Treatment 1 Intervention

ERAS-4001 administered orally with another investigational agent.

Who Is Running the Clinical Trial?

Erasca, Inc.

Lead Sponsor

Trials

8

Recruited

1,200+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07021898

NCT07021898 | A Study of ERAS-4001 in Patients With ...

The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic ...

2.

investors.erasca.com

investors.erasca.com/news-releases/news-release-details/erasca-announces-early-clinical-advancement-and-prioritization

News Release Details

No activity was observed for ERAS-4001 against HRAS or NRAS wildtype proteins, which may enable a wider clinical therapeutic window compared to ...

3.

theglobeandmail.com

theglobeandmail.com/investing/markets/markets-news/Tipranks/35741799/erasca-inc-advances-with-promising-phase-1-study-on-eras-4001/

Erasca, Inc. Advances with Promising Phase 1 Study on ...

' The study aims to evaluate the safety and tolerability of ERAS-4001, a novel treatment for patients with advanced or metastatic solid tumors ...

4.

firstwordpharma.com

firstwordpharma.com/story/5967926

Erasca Announces IND Clearance for Potential First-in- ...

In preclinical studies, ERAS-4001 showed encouraging absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07021898?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(%22Panitumumab%22))&rank=2

A Study of ERAS-4001 in Patients With Advanced or ...

The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.

6.

cancer.gov

cancer.gov/clinicaltrials/NCI-2025-04691

A Study of ERAS-4001 in Patients With Advanced or ...

The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or ...

7.

investors.erasca.com

investors.erasca.com/news-releases/news-release-details/erasca-announces-ind-clearance-potential-first-class-and-best

Erasca Announces IND Clearance for Potential First-in- ...

ERAS-4001 demonstrated good preclinical in vitro potency against KRAS G12X mutations, as well as KRAS wildtype amplifications, which may limit ...