ERAS-601 for Advanced Solid Cancer

(FLAGSHP-1 Trial)

Recruiting at 14 trial locations

Overseen By Erasca Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Erasca, Inc.

Must not be taking: SHP2 inhibitors

Disqualifiers: CNS disease, PTPN11 mutations, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

* To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors. * To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving another study therapy or have taken an investigational agent within 4 weeks of starting this trial.

Research Team

Les Brail, PhD

Principal Investigator

Clinical Development

Eligibility Criteria

This trial is for adults (18+) with advanced or metastatic solid tumors who have no standard treatment options left, can't tolerate the usual treatments, or choose not to use them. Participants must be able to take oral medication and have a good performance status, meaning they're fully active or restricted in physically strenuous activity but can still carry out work of a light nature.

Inclusion Criteria

Willing to comply with all protocol-required visits, assessments, and procedures

I can't use standard cancer treatments due to side effects, ineffectiveness, or access issues.

I am fully active or can carry out light work.

Exclusion Criteria

I have been treated with a SHP2 inhibitor before.

Is 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-601

I have brain cancer or cancer that has spread to my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

ERAS-601 monotherapy is administered in sequential ascending doses to determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD)

4 weeks

Weekly visits for dose escalation

Dose Expansion

Once the MTD/RD is determined, ERAS-601 monotherapy is expanded to more participants with specific molecular alterations

Variable, based on participant response

Combination Therapy Dose Escalation

ERAS-601 is administered with cetuximab or pembrolizumab in sequential ascending doses to determine the combination therapy MTD/RD

4 weeks

Weekly visits for combination therapy dose escalation

Combination Therapy Dose Expansion

Once the combination therapy MTD/RD is determined, the treatment is expanded to more participants with specific cancer types

Variable, based on participant response

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits as per study protocol

Treatment Details

Interventions

• ERAS-601

Trial Overview The study tests different doses of ERAS-601 alone and alongside cancer drugs Cetuximab and Pembrolizumab. It aims to find the highest dose patients can take without serious side effects (MTD), decide on a recommended dose (RD), understand how the body processes the drug (PK profile), and assess its effectiveness against tumors.

Participant Groups

Group I: Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembrolizumab Experimental Treatment 2 Interventions

ERAS-601 will be administered in sequential ascending doses with pembrolizumab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or non small cell lung cancer (NSCLC).

Group II: Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuximab Experimental Treatment 2 Interventions

ERAS-601 will be administered in sequential ascending doses with cetuximab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC).

Group III: Dose Escalation (Part C): ERAS-601 monotherapy Experimental Treatment 1 Intervention

ERAS-601 will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent.

Group IV: Dose Escalation (Part B): ERAS-601 monotherapy Experimental Treatment 1 Intervention

ERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.

Group V: Dose Escalation (Part A): ERAS-601 monotherapy Experimental Treatment 1 Intervention

ERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.

Who Is Running the Clinical Trial?

Erasca, Inc.

Lead Sponsor

Trials

8

Recruited

1,200+