What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, particularly those involving EGFR inhibitors like cetuximab and panitumumab, often result in side effects such as skin rash, diarrhea, and hypomagnesemia. The FOLFOX chemotherapy regimen, which includes oxaliplatin, fluorouracil, and leucovorin, is associated with peripheral neuropathy, neutropenia, fatigue, and gastrointestinal symptoms like nausea and diarrhea.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies targeting EGFR for the treatment of colorectal cancer. Notably, cetuximab and panitumumab are two such agents. Cetuximab is often used in combination with chemotherapy regimens like FOLFOX or FOLFIRI for metastatic colorectal cancer, particularly in patients with wild-type KRAS genes. Panitumumab is another EGFR inhibitor approved for use in similar settings, also targeting patients with wild-type KRAS. These treatments have shown efficacy in improving progression-free survival and overall response rates in colorectal cancer patients.

What other types of research exist?

Promising novel alternatives to Sotevtamab for colorectal cancer patients include: 1) Immunotherapy agents such as pembrolizumab and nivolumab, especially for patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). 2) Targeted therapies like encorafenib combined with cetuximab for BRAF V600E-mutant colorectal cancer. 3) Newer tyrosine kinase inhibitors (TKIs) such as regorafenib and fruquintinib, which have shown efficacy in advanced colorectal cancer. 4) Combination therapies involving bevacizumab with chemotherapy regimens. These alternatives are based on recent clinical trial data and advancements in the field.

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Sotevtamab + FOLFOX for Colorectal Cancer (EGIA-003 Trial)

Phase 2

Recruiting

Research Sponsored by Alethia Biotherapeutics

Eligibility Criteria Checklist

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

Must have

Participants (male or non-pregnant female) must be ≥ 18 years of age on the day of signing the informed consent.

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Must not have

Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome)

Concurrent administration of anti-VGFR, anti-EGFR, anti-VEGF or other biological or targeted therapy with neoadjuvant FOLFOX

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 3, 8 and between weeks 14 and 16

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, Sotevtamab, combined with standard chemotherapy in colorectal cancer patients whose cancer has spread mainly to the liver. The goal is to shrink the tumors before surgery to make them easier to remove.

Who is the study for?

This trial is for colorectal cancer patients with liver metastases. Participants must be eligible for surgery to remove these metastases and have not yet had any treatment specifically targeting the liver tumors.

What is being tested?

The study tests Sotevtamab, given weekly, combined with FOLFOX chemotherapy every two weeks. This regimen is followed for six cycles before surgical removal of the liver metastases.

What are the potential side effects?

Potential side effects may include reactions at the injection site, fatigue, nausea from chemotherapy, and possible increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years or older and can sign the consent form.

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I can take care of myself but might not be able to do heavy physical work.

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I have stage IV colon or rectal cancer with liver metastases suitable for surgery.

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I have a liver tumor that can be safely biopsied.

Exclusion Criteria

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

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I have a genetic form of colorectal cancer.

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I am not taking any targeted cancer drugs with my FOLFOX treatment.

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My colorectal cancer lacks a certain DNA repair mechanism.

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I have not received a live vaccine within 30 days before starting the trial treatment.

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I haven't taken more than 10 mg/day of prednisone or any immunosuppressants in the last week.

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I am currently taking antibiotics for an infection.

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I have previously been treated with sotevtamab.

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I have nerve damage in my hands or feet that affects my daily activities.

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I have an active Hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 3, 8 and between weeks 14 and 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 3, 8 and between weeks 14 and 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 3, 8 and between weeks 14 and 16 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rubbia-Brandt score at surgery

Treatment-Emergent Adverse Events

Secondary study objectives

Objective Response Rate (ORR)

Presence of ADA

Quantity of circulating tumor DNA (ctDNA)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sotevtamab and FOLFOXExperimental Treatment2 Interventions

Sotevtamab at 800 mg IV infusion once weekly on Days 1 and 8 for 6 cycles combined with FOLFOX (oxaliplatin 85 mg/m² IV infusion + leucovorin 400 mg/m² IV infusion + 5-Fluorouracil (5-FU) 400 mg/m² IV bolus + 5-FU 2400 mg/m² continuous IV infusion over 46 hours) once every 2 weeks on Day 1 for the first 4 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFOX

2009

Completed Phase 3

~4560

0 / 13Eligibility 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

Colorectal cancer treatments often include chemotherapy, targeted therapies, and monoclonal antibodies. Chemotherapy, such as FOLFOX (a combination of fluorouracil, leucovorin, and oxaliplatin), works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, like cetuximab and panitumumab, are monoclonal antibodies that specifically target the epidermal growth factor receptor (EGFR) on cancer cells, inhibiting their growth and survival. Sotevtamab, another monoclonal antibody targeting EGFR, is being studied for its potential to enhance the effectiveness of chemotherapy. These treatments are crucial for colorectal cancer patients as they offer multiple mechanisms to attack cancer cells, potentially improving outcomes and survival rates.