Neoplasms

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Stomach Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immunoglobulins

Mitogens

Trastuzumab

Trastuzumab deruxtecan

Immunoconjugates

Immunologic Factors

DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W)

DS-8201a

Global Clinical Leader

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate.

The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8 months. The screening period is 28 days and each cycle of treatment is 21 days.

The number of treatment cycles is not fixed in this study. Subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study drug.

DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein

Phase 1, Multicenter, Open-label Study of DS-8201a to Assess Safety and Pharmacokinetics in Subjects With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug.

Maximum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.

Maximum concentration (Cmax) of MAAA-1181a was assessed.

Area under the serum concentration-time curve during dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody was assessed.

Area under the serum concentration-time curve during dosing interval (AUCtau) of MAAA-1181a was assessed.

Best overall response (BOR) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Objective response rate (ORR; defined as participants who achieved CR and PR) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Disease control rate (DCR; defined as participants who achieved CR, PR, and SD) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions.

AstraZeneca

Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company

Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Taiwan

Region of Enrollment

Baseline demographics were assessed in the Safety Analysis Set.

Contact for Clinical Trial Information

Any TEAE

Any drug-related TEAE

Any TEAE of CTCAE Grade ≥3

Any drug-related TEAE of CTCAE Grade ≥3

Any serious TEAE

Any drug-related serious TEAE

Any serious TEAE of CTCAE Grade ≥3

Any drug-related serious TEAE of CTCAE Grade ≥3

Any TEAE leading to drug withdrawal

Any TEAE leading to dose reduction

Any drug-related TEAE leading to dose reduction

Any TEAE leading to dose interruption

Any drug-related TEAE leading to dose interruption

Any TEAE leading to death

Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.

Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)

DS-8201a, Cycle 1

DS-8201a, Cycle 3

Total Anti-HER2 antibody, Cycle 1

Total Anti-HER2 antibody, Cycle 3

Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)

MAAA-1181a, Cycle 1

MAAA-1181a, Cycle 3

Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)

Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)

Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)

Complete response (CR)

Partial response (PR)

Stable disease (SD)

Non-Complete Response (CR)/Non-Progressive Disease (PD)

Progressive Disease (PD)

Non-evaluable (NE)

Response was assessed in the Response Evaluable Set.

Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer

Response was evaluated in the Response Evaluable Set.

Objective Response Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer

Disease Control Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein	NCT03368196	Adenocarcinoma,... Neoplasm, Breas...	DS-8201a	20 Years -	Daiichi Sankyo
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein	NCT03368196	Adenocarcinoma,... Neoplasm, Breas...	DS-8201a	20 Years -	Daiichi Sankyo

Spots Global Cancer Trial Database for human epidermal growth factor 2