A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2 expressing Gastric Cancer

Phase 1

• Conditions: Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing gastric, GEJ and esophageal cancer; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004483-22-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 417

Inclusion Criteria

1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
2. Disease Characteristics:
a/Locally advanced, unresectable, or metastatic disease based on most recent imaging
b/For Part 1, 2, 3a and 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+)
based on local tissue testing results
c/For Part 3b and 4b, pathologically documented adenocarcinoma of the
stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+)
based on local tissue testing results
3. For Part 1, progression on or after at least one prior trastuzumab containing regimen
For Part 2 and Part 3 and Part 4, previously untreated for unresectable or
metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3, Arm 3A, Part 4, Arm 4A) or HER2-low (Part 3, Arm 3B, Part 4, Arm 4B) status
4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
5. Has protocol-defined adequate bone marrow and organ function
including cardiac, renal and hepatic function
6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for female and 6 months (all treatment arms except Arm 2B) or 4 months (Arm 2B) for male patients
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 312
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 229

Exclusion Criteria

1.History of active primary immunodeficiency, known HIV, active HBV or HCV infection.
2.Uncontrolled intercurrent illness.
3.History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
4.Lung-specific intercurrent clinically significant severe illnesses.
5.Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
6.Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
7. Has spinal cord compression or clinically active central nervous system metastases.

Study & Design

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