Study of Margetuximab in Combination with INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in HER2-Positive Gastric or Gastroesophageal Junction Cancer

Phase 1

• Conditions: Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer; MedDRA version: 23.0Level: PTClassification code 10066896Term: HER2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004699-21-DE
• Lead Sponsor: MacroGenics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-04
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

1. Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
- Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS = 1%), per central review.

- Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment.

-Prior systemic perioperative treatment is allowed; however the patient must have had a disease-free interval of at least 6 months from end of chemo/surgery.

-Patients receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility.

2. Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing

3. Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1

4. Life expectancy = 6 months

5. At least one radiographically measurable target lesion

6. Acceptable laboratory parameters and adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 460
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions
-Patients with known MSI-H status

2. History of allogeneic stem cell or tissue/solid organ transplant

3. Central nervous system metastases

4. Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise

5. Prior neoadjuvant or adjuvant treatment with immunotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified