ERAS-007 Combination Therapy for Gastrointestinal Cancer
(HERKULES-3 Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Erasca, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ERAS-007 combined with other cancer treatments to see if it is safe and effective for patients with advanced gastrointestinal cancers. The study focuses on patients with specific genetic mutations in their cancer cells, which are often hard to treat. ERAS-007 aims to target these mutations to help stop the cancer from growing.

Research Team

Joyce Antal

Principal Investigator

Clinical Development

Eligibility Criteria

This trial is for adults (18+) with advanced gastrointestinal cancers, specifically metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC), that have certain mutations. Participants must be in good health otherwise, able to take oral medication, and willing to follow the study procedures. People with brain metastasis, significant heart disease, recent thrombosis or stroke, prior treatment with similar drugs, or those who are pregnant can't join.

Inclusion Criteria

My organs and bone marrow are working well.

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

I am fully active or restricted in physically strenuous activity but can do light work.

See 5 more

Exclusion Criteria

I have not had major surgery in the last 28 days and do not plan to during the study.

I have a serious lung condition that is not under control.

I have a stomach or intestine condition that affects how I absorb pills.

See 11 more

Treatment Details

Interventions

ERAS-007 (Other)

Trial OverviewThe trial tests escalating doses of ERAS-007 combined with other cancer treatments like Encorafenib, Cetuximab, and Palbociclib. It aims to find the safest high dose of ERAS-007 when used together with these therapies and assess how well they work against tumors by measuring their anti-cancer activity.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Dose Expansion (Parts B1b, B2b, B3b, and B4b): ERAS-007 in combination with palbociclibExperimental Treatment2 Interventions

ERAS-007 will be orally administered at the recommended dose (as determined from Parts B1a, B2a, B3a or B4a) in combination with palbociclib to study participants with KRASm or NRASm CRC.

Group II: Dose Expan (Parts A1b, A1c, A2b, A2c, A3b, or A3c): ERAS-007 in combo with encorafenib & cetuximabExperimental Treatment3 Interventions

ERAS-007 will be orally administered at the recommended dose (as determined from Parts A1a, A2a or A3a) in combination with encorafenib and cetuximab to study participants with BRAFm CRC.

Group III: Dose Escalation (Parts B1a, B2a, B3a or B4a): ERAS-007 in combination with palbociclibExperimental Treatment2 Interventions

ERAS-007 will be orally administered in combination with palbociclib to study participants with KRASm or NRASm CRC and KRASm PDAC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.

Group IV: Dose Escalation (Parts A1a, A2a, or A3a): ERAS-007 in combination with encorafenib and cetuximabExperimental Treatment3 Interventions

ERAS-007 will be orally administered in combination with encorafenib and cetuximab to study participants with BRAFm CRC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.