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Sotevtamab and 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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

EGIA-003 Trial Summary

This trial will include 17 patients with colorectal cancer that has spread to the liver. The patients will be given a drug called Sotevtamab once a week for 6 cycles, along

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.Check my eligibility

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.See study design

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.

EGIA-003 Trial 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.

EGIA-003 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rubbia-Brandt score at surgery

Treatment-Emergent Adverse Events

Secondary outcome measures

Objective Response Rate (ORR)

Presence of ADA

Quantity of circulating tumor DNA (ctDNA)

+1 more

EGIA-003 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alethia BiotherapeuticsLead Sponsor

2 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing trial?

"According to the information provided on clinicaltrials.gov, this particular clinical trial is not currently accepting participants. The trial was initially posted on February 1st, 2024 and was last updated on January 17th, 2024. However, it's worth noting that there are currently 1489 other studies actively seeking patients for enrollment."

Answered by AI

Has the Food and Drug Administration (FDA) granted approval for Sotevtamab in combination with FOLFOX as a treatment option?

"Given that this trial is in Phase 2, our team at Power rates the safety of Sotevtamab and FOLFOX as a 2. This means there is some available data supporting safety but no evidence yet regarding efficacy."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary objective of this trial is to assess the Rubbia-Brandt score at the time of surgery within a timeframe spanning 14 to 16 weeks. Secondary endpoints encompass evaluating the quantity of circulating tumor DNA (ctDNA) for minimal residual disease detection after resection of colorectal liver metastases, examining the presence and impact of anti-sotevtamab antibodies (ADA) on exposure and tumor response in the trial population, as well as determining sotevtamab concentrations in plasma to establish its pharmacokinetics (PK)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis

2024. "Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225843.