What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine plus nab-paclitaxel and FOLFIRINOX, are associated with several side effects. For gemcitabine plus nab-paclitaxel, grade 3 or 4 toxicities include neutropenia, fatigue, neuropathy, and diarrhea. FOLFIRINOX, another combination therapy, often results in neutropenia, fatigue, vomiting, and diarrhea. Targeted therapies and novel agents like ERAS-007, when combined with these treatments, may also present similar side effects, including hematologic toxicities (e.g., neutropenia), gastrointestinal issues (e.g., nausea, diarrhea), and neuropathy. The specific side effects of ERAS-007 are still under investigation, but they are expected to align with those observed in combination therapies.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including combination therapies like FOLFIRINOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan) and gemcitabine plus nab-paclitaxel. These treatments have shown a survival benefit over single-agent therapies. Additionally, targeted therapies and novel agents, such as pembrolizumab for tumors with specific genetic markers (MSI-H/dMMR), have been approved for use in various cancers, including pancreatic cancer. These treatments aim to enhance the efficacy of existing therapies, similar to the approach being studied with ERAS-007.

What other types of research exist?

Promising novel alternatives to ERAS-007 for pancreatic cancer patients include HF10, an oncolytic virus administered via EUS-guided intratumoral injection in combination with erlotinib and gemcitabine, and aflibercept, which has been investigated in combination with gemcitabine in a phase III study for metastatic pancreatic cancer. Both therapies are designed to work synergistically with existing treatments and have shown potential in clinical trials.

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

Phase 1 & 2

Waitlist Available

Research Sponsored by Erasca, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have ECOG performance status of 0 or 1

Age ≥ 18 years

Must not have

Major surgery within 28 days of enrollment, or anticipation of major surgery during study treatment

Active, clinically significant interstitial lung disease or pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 24 months from time of first dose

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include typical reactions from cancer medications such as fatigue, nausea, skin reactions from Cetuximab; increased risk of infections due to bone marrow suppression; liver issues from Encorafenib; and possible bleeding problems related to Palbociclib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My colorectal or pancreatic cancer has specific genetic mutations.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I received palliative radiation within the last week before starting the study drug.

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I do not have an active infection needing treatment or a history of HIV, hepatitis B, or C.

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I have brain metastasis or leptomeningeal disease causing symptoms.

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I have heart problems or significant heart disease.

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I am allergic or cannot take encorafenib, cetuximab, or palbociclib due to health reasons.

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I haven't had cancer treatment in the last 3 weeks or within 4 half-lives of the treatment, whichever is shorter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 24 months from time of first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 24 months from time of first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 24 months from time of first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Dose Limiting Toxicities (DLT)

Maximum Tolerated Dose (MTD)

+1 more

Secondary study objectives

Area under the curve

Duration of Response (DOR)

Half-life

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Encorafenib

2022

Completed Phase 3

~970

ERAS-007

2021

Completed Phase 1

~30

Palbociclib

2017

Completed Phase 3

~3880

Cetuximab

2011

Completed Phase 3

~2480

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and novel agents like ERAS-007. Chemotherapy, such as FOLFIRINOX and gemcitabine-based regimens, works by damaging the DNA of rapidly dividing cancer cells, thereby inhibiting their growth and inducing cell death. Targeted therapies, like PARP inhibitors for patients with BRCA mutations, specifically interfere with molecular targets involved in cancer cell proliferation and survival. Novel agents like ERAS-007 are designed to enhance the efficacy of existing treatments by targeting specific pathways or mechanisms within cancer cells, potentially improving outcomes and reducing resistance. These treatments are crucial for pancreatic cancer patients as they offer more personalized and effective options, potentially leading to better management of the disease and improved survival rates.