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Clinical Trial NCT07477444 (HER-OIC) for Gastroesophageal Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer (HER-OIC) Phase 1, Phase 2 29 Immunotherapy Targeted Therapy

Not yet recruiting
Clinical Trial NCT07477444 (HER-OIC) is designed to study Treatment for Gastroesophageal Cancer. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 June 2026 until the study accrues 29 participants. Led by Universitaire Ziekenhuizen KU Leuven, this study is expected to complete by 1 June 2033. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief Summary
The HER-OIC clinical trial is a Phase 1b/2a study investigating a new combination of treatments for patients with HER2-positive gastroesophageal cancer. Standard treatment for localized gastroesophageal cancer usually involves chemotherapy before and after surgery. This study aims to see if adding targeted therapy (zanidatamab) and immunotherapy (tislelizumab) to standard chemotherapy is safe and effectively eliminat...Show More
Official Title

Perioperative Zanidatamab Combined With Chemotherapy in Operable HER2 Positive Locally Advanced Operable Gastroesophageal Adenocarcinoma (GEA): A Phase 1b/2a Single-Arm Trial

Conditions
Gastroesophageal Cancer
Other Study IDs
  • HER-OIC
  • S71017
NCT ID Number
NCT07477444
Start Date (Actual)
2026-06-01
Last Update Posted
2026-03-20
Completion Date (Estimated)
2033-06
Enrollment (Estimated)
29
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPerioperative Zanidatamab and Chemotherapy
This is a single-arm, open-label trial where participants are assigned to receive specific interventions (zanidatamab, chemotherapy, tislelizumab) based on the study protocol.
Zanidatamab Combined with Chemotherapy
This intervention combines perioperative zanidatamab with chemotherapy and the PD-1 inhibitor tislelizumab for HER2-positive gastroesophageal adenocarcinoma
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of Qualifying Safety Events (Phase 1b Safety Run-in)
The primary safety endpoint is the incidence of "qualifying safety events," defined as Grade ≥3 diarrhea or any Grade ≥3 treatment-emergent toxicity that results in the inability to administer the planned neoadjuvant chemotherapy or zanidatamab.
During the neoadjuvant period, which start from the first treatment administration and continues until the end of the fourth preoperative 14-day cycle (8 weeks)
Pathological Complete Response (pCR) Rate (Total Population)
The primary efficacy endpoint is the improvement of the pCR rate, defined as the percentage of patients with no residual invasive cancer in the completely resected tumor specimen and sampled regional lymph nodes. The study aims to detect an improvement from a historical 8% to a 30% pCR rate across the total 29-patient cohort.
At the time of surgery, which occurs 4 to 12 weeks after the last dose of pre-operative treatment (approximately 12 to 20 weeks after the first dose)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Voluntary written informed consent from the participant or their legally authorized representative
  • At least 18 years of age at the time of signing the consent form
  • Agreement to use highly effective birth control methods for both male and female patients
  • WHO-ECOG performance status of 0 or 1
  • Histologically proven HER2-positive gastroesophageal, esophageal, or gastric adenocarcinoma
  • Localized, resectable disease that is fit for perioperative treatment, including surgery
  • Adequate hepatic function
  • Adequate renal function with an estimated Glomerular Filtration Rate (GFR) > 50 mL/min
  • Adequate hematologic function
  • Cardiac ejection fraction

  • Prior neoadjuvant or definitive chemoradiation
  • Squamous cell cancer of the esophagus
  • Metastatic or unresectable gastroesophageal cancer
  • Active or relapsing autoimmune diseases, with exceptions for controlled Type 1 diabetes, hypothyroidism (hormone replacement only), controlled celiac disease, or certain skin diseases not requiring systemic treatment
  • Known hypersensitivity to zanidatamab, tislelizumab, or any of their excipients
  • Known Dihydropyrimidine Dehydrogenase (DPD) deficiency
  • Active infections requiring systemic treatment
  • History of significant cardiac disease
  • Previous malignancy within the last 5 years
  • Current participation in another interventional Trial involving an investigational medicinal product or device
Universitaire Ziekenhuizen KU Leuven logoUniversitaire Ziekenhuizen KU Leuven
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