DS-8201a in HER2-positive Gastric Cancer that cannot be surgically removed or has spread

Phase 1

• Conditions: nresectable or metastatic gastric or gastro-esophageal junction (GEJ)adenocarcinoma that has progressed on or after a trastuzumab-containingregimen; MedDRA version: 21.1Level: LLTClassification code 10071114Term: Metastatic gastric adenocarcinomaSystem 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: EUCTR2019-001512-34-BE
• Lead Sponsor: Daiichi Sankyo Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-30
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Key Inclusion Criteria:
- Men or women =18 years old (Please follow local regulatory requirements if the legal age of consent for study participation is >18 years old.)
- Has pathologically documented gastric or GEJ cancer that is:
- Unresectable or metastatic
- Centrally confirmed HER2-positive disease (immunohistochemistry [IHC]3+, IHC2+/in-situ hybridization [ISH]+) as determined according to American Society of Clinical Oncology – College of American Pathologists (ASCO CAP) guidelines new tumor biopsy obtained after progression on or after a first-line trastuzumab-containing regimen. If a tumor biopsy was already collected after discontinuation of first-line treatment with a trastuzumab-containing regimen, it is acceptable to consider the biopsy to be a new biopsy for the purpose of this study, provided that there is sufficient tissue for exploratory biomarker studies.
- Has experienced disease progression during or after first-line therapy with a trastuzumab-containing regimen (brand or approved biosimilar). Note: Prior adjuvant therapy with a trastuzumab-containing regimen can be counted as a line of therapy if the subject progressed on or within 6 months of completing adjuvant therapy.
- Has at least 1 measurable lesion per RECIST v1.1 as confirmed by the investigator review.
- Has left ventricular ejection fraction (LVEF) =50% within 28 days before first dose per echocardiogram (ECHO)/multigated acquisition (MUGA) scan.
- Has adequate organ function within 14 days before first dose, defined as in the protocol
- Male and female subjects of reproductive/childbearing potential must agree 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 females and 4 months for males after the last dose of study drug.

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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Key Exclusion Criteria:
- Use of anticancer therapy after first-line treatment with a trastuzumab-containing regimen.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction (MI) within 6 months of first dose
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV)
- Troponin levels consistent with MI as defined according to the manufacturer within 28 days prior to first dose
- Corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (male) based on Screening triplicate 12-lead electrocardiogram (ECG)
- History of (non-infectious) interstitial lung disease (ILD)/ pneumonitis that required corticosteroid therapy or has current ILD/pneumonitis or is suspected to have such diseases by imaging during Screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the first dose, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.
- Pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). (Drainage and Cell-free and CART are not allowed within 2 weeks prior to or during Screening.)
- Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Subjects with clinically inactive brain metastases may be included in the study.
- Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study recruitment (1 week for stereotactic radiotherapy).

Study & Design

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