A Phase 1 interventional study of DS-8201a in Adenocarcinoma, Gastric and Neoplasm, Breast, sponsored by Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company. Completed at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company (part of Daiichi Sankyo) · Phase 1, Interventional, and Treatment
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.
620 studies on the registry are indexed under Adenocarcinoma; 148 are open to participants now.
This study's enrollment of 12 is below the median of 57 across 490 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has any other history or condition that might compromise:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W)
Drug: DS-8201a
An antibody drug conjugate
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
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.
Time frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dose
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
Maximum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.
Time frame: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOI
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
Maximum concentration (Cmax) of MAAA-1181a was assessed.
Time frame: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOI
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)
Area under the serum concentration-time curve during dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody was assessed.
Time frame: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOI
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)
Area under the serum concentration-time curve during dosing interval (AUCtau) of MAAA-1181a was assessed.
Time frame: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOI
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
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.
Time frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dose
Objective Response Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
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.
Time frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dose
Disease Control Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
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.
Time frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dose
A total of 12 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment in Taiwan.
| Milestone | DS-8201a |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| Participants | DS-8201a |
|---|---|
| Any TEAE | 12 |
| Any drug-related TEAE | 12 |
| Any TEAE of CTCAE Grade ≥3 | 7 |
| Any drug-related TEAE of CTCAE Grade ≥3 | 6 |
| Any serious TEAE | 2 |
| Any drug-related serious TEAE | 1 |
| Any serious TEAE of CTCAE Grade ≥3 | 2 |
| Any drug-related serious TEAE of CTCAE Grade ≥3 | 1 |
| Any TEAE leading to drug withdrawal | 0 |
| Any TEAE leading to dose reduction | 2 |
| Any drug-related TEAE leading to dose reduction | 2 |
| Any TEAE leading to dose interruption | 5 |
| Any drug-related TEAE leading to dose interruption | 5 |
| Any TEAE leading to death | 0 |
Maximum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.
| ug/mL | DS-8201a |
|---|---|
| DS-8201a, Cycle 1 | 157 ± 19.1 |
| DS-8201a, Cycle 3 | 163 ± 19.5 |
| Total Anti-HER2 antibody, Cycle 1 | 150 ± 22.6 |
| Total Anti-HER2 antibody, Cycle 3 | 154 ± 16.6 |
Maximum concentration (Cmax) of MAAA-1181a was assessed.
| ng/mL | DS-8201a |
|---|---|
| MAAA-1181a, Cycle 1 | 11.9 ± 3.79 |
| MAAA-1181a, Cycle 3 | 9.01 ± 1.36 |
Area under the serum concentration-time curve during dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody was assessed.
| ug*d/mL | DS-8201a |
|---|---|
| DS-8201a, Cycle 1 | 631 ± 173 |
| DS-8201a, Cycle 3 | 991 ± 109 |
| Total Anti-HER2 antibody, Cycle 1 | 821 ± 312 |
| Total Anti-HER2 antibody, Cycle 3 | 1180 ± 208 |
Area under the serum concentration-time curve during dosing interval (AUCtau) of MAAA-1181a was assessed.
| ng*d/mL | DS-8201a |
|---|---|
| MAAA-1181a, Cycle 1 | 36.1 ± 9.71 |
| MAAA-1181a, Cycle 3 | 41.3 ± 5.06 |
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.
| Participants | DS-8201a |
|---|---|
| Complete response (CR) | 0 |
| Partial response (PR) | 4 |
| Stable disease (SD) | 7 |
| Non-Complete Response (CR)/Non-Progressive Disease (PD) | 0 |
| Progressive Disease (PD) | 0 |
| Non-evaluable (NE) | 0 |
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.
| Participants | DS-8201a |
|---|---|
| Objective Response Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer | 4 |
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.
| Participants | DS-8201a |
|---|---|
| Disease Control Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer | 11 |
Collected over Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DS-8201a | 0/12 (0%) | 2/12 (16.7%) | 12/12 (100%) |
| Event | DS-8201a |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/12 |
| Urinary tract infectionInfections and infestations | 1/12 |
| Event | DS-8201a |
|---|---|
| NauseaGastrointestinal disorders | 7/12 |
| Platelet count decreasedInvestigations | 7/12 |
| Aspartate aminotransferase increasedInvestigations | 6/12 |
| White blood cell count decreasedInvestigations | 5/12 |
| AnaemiaBlood and lymphatic system disorders | 4/12 |
| Alanine aminotransferase increasedInvestigations | 4/12 |
| Decreased appetiteMetabolism and nutrition disorders | 4/12 |
| StomatitisGastrointestinal disorders | 3/12 |
| FatigueGeneral disorders | 3/12 |
| Blood bilirubin increasedInvestigations | 3/12 |
Baseline demographics were assessed in the Safety Analysis Set.
| Age, Categorical(Participants) | DS-8201a |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 1 |
| Age, Continuous(years) | DS-8201a |
|---|---|
| Mean | 54.8 ± 8.73 |
| Sex: Female, Male(Participants) | DS-8201a |
|---|---|
| Female | 12 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | DS-8201a |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 12 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | DS-8201a |
|---|---|
| Taiwan | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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/
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
Ran from Apr 2018 to primary completion in Sep 2018, 5 months.
Results were first posted in Jun 2021, 2 years 9 months after primary completion.
Of 50 phase 1 interventional studies under Adenocarcinoma, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 64. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab deruxtecan