Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

Phase 1

Recruiting

• Conditions: adenocarcinoma of the stomach, GEJ, or esophagus

• Registration Number: JPRN-jRCT2031200203
• Lead Sponsor: Inoguchi Akihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-17
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Male and female participants must be at least 18 years of age (20 years of age in Japan)
2. Disease Characteristics:
Locally advanced, unresectable, or metastatic disease based on most recent imaging. For Part 1, 2, 3a pathologically documented adenocarcinoma of the stomach, GEJ, or esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH-positive) based on existing local tissue testing results. For Part 3b, pathologically documented adenocarcinoma of the stomach, GEJ, or esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on existing local tissue testing results.
3. For Part 1, progression on or after at least one prior trastuzumab-containing regimen. Previously untreated for unresectable or metastatic adenocarcinoma of the stomach, GEJ, or esophagus, with HER2-positive (Part 2 and Part 3, Arm 3A) or HER2-low (Part 3, Arm 3B) status
4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1
5. Has protocol-defined adequate 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 (female) or 6 months (male) after last dose of study drug.

Exclusion Criteria

1. History of active primary immunodeficiency, known HIV, active HBV or HCV infection, or active tuberculosis.
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
• Study Design: Not specified