Not Yet RecruitingPhase 2

Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers

43 participantsStarted 2026-11-01

Plain-language summary

Purpose: This clinical trial is designed to evaluate the safety and effectiveness of Trastuzumab Deruxtecan for patients with HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer. The goal is to determine how well this treatment works and to identify any potential side effects. Who Can Participate: We are looking for Participants with histologically confirmed HER2 positive locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma with an ECOG PS of 2 and measurable disease according to RECIST 1.1 within 42 days prior to registration. Participants will be carefully screened to ensure they meet the study requirements. What to Expect: Participants will undergo 6.4mg/kg, IV infusion of Trastuzumab deruxtucan over the course of the study. They will receive detailed information about the study and will have the opportunity to ask questions before deciding to participate. Informed consent will be obtained to ensure that participants understand the study's purpose, procedures, risks, and benefits. Safety Monitoring: The health and safety of participants are our top priority. An Independent Data and Safety Monitoring Committee (DSMC) will regularly review the study data to ensure participant safety and to monitor for any adverse events. Any serious side effects will be reported and addressed promptly. Benefits and Risks: While the study aims to provide potential benefits, such as improved treatment options for HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer there may also be risks involved. Participants will be informed of all possible risks before enrolling in the study. Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes. Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.1.2 Participants must be ≥ 18 years of age at the time of consent.
✓.1.3 Participants must have histologically confirmed locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma per AJCC, 8th edition.
✓.1.4 Participants must have measurable disease according to RECIST 1.1 within 42 days prior to registration.
✓.1.5 Participants must have an ECOG PS of Grade 2 within 28 days prior to registration.
✓.1.6 Participants must NOT be candidates for combination therapy per treating provider judgement.
✓.1.7 Participants must have HER2 protein overexpression or HER2 gene amplification in tumor tissue (preferred on tumor tissue biopsy if available) or liquid biopsy. (Note: HER2 levels considered positive Score 3+ on IHC, Score of 2+ with positive results of FISH)
✓.1.8 Prior definitive chemoradiation therapy for localized disease, systemic therapy including immunotherapy in the adjuvant setting is allowed.
✓.1.9 Prior cancer treatment in the adjuvant setting must be completed at least 3 months prior to registration and the participant must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.

What they're measuring

Objective Response Rate

Timeframe: 12 months

Trial details

NCT IDNCT07126561

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11-01

Contact for this trial

Manik Amin, MD

(773) 702-4400 PhaseIICRA@medicine.bsd.uchicago.edu

View on ClinicalTrials.gov More HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer Patients With an ECOG Performance Status of 2 trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.1.2 Participants must be ≥ 18 years of age at the time of consent.
✓.1.3 Participants must have histologically confirmed locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma per AJCC, 8th edition.
✓.1.4 Participants must have measurable disease according to RECIST 1.1 within 42 days prior to registration.
✓.1.5 Participants must have an ECOG PS of Grade 2 within 28 days prior to registration.
✓.1.6 Participants must NOT be candidates for combination therapy per treating provider judgement.
✓.1.7 Participants must have HER2 protein overexpression or HER2 gene amplification in tumor tissue (preferred on tumor tissue biopsy if available) or liquid biopsy. (Note: HER2 levels considered positive Score 3+ on IHC, Score of 2+ with positive results of FISH)
✓.1.8 Prior definitive chemoradiation therapy for localized disease, systemic therapy including immunotherapy in the adjuvant setting is allowed.
✓.1.9 Prior cancer treatment in the adjuvant setting must be completed at least 3 months prior to registration and the participant must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.

Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria