TriangleNCT02564900 · OUTCOME
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From 6 months postdose of last participant up to 3 years 5 months
What was measured
Best overall response by independent central review was defined as the proportion of participants who achieved either complete response \[CR\], partial response \[PR\], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD 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. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
Analysis population: Best overall response was assessed in the Intent-to-Treat Analysis Set.
Groups in this outcome
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
| Group | Source count |
|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 3 |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 3 |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 6 |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 51 |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 67 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 21 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 33 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 19 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 25 |
| Dose Expansion: HER2-expressing NSCLC Tumors | 18 |
| Dose Expansion: HER2-expressing Colorectal Tumors | 20 |
| Dose Expansion: HER2-expressing Other Solid Tumors | 23 |
Reported measurements
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing NSCLC Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Colorectal Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 2 | Not reported | Not reported | Not reported | Not reported |
Partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 24 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 28 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 13 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing NSCLC Tumors | 10 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Colorectal Tumors | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 19 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 28 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 16 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 10 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 14 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing NSCLC Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Colorectal Tumors | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 12 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing NSCLC Tumors | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Colorectal Tumors | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 3 | Not reported | Not reported | Not reported | Not reported |
Non-evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing NSCLC Tumors | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Colorectal Tumors | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
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- OG002
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- 1
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- 2
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- title
- Complete response
- categories
- measurements
- group Id
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- 0
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- 13
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- 5
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- 7
- title
- Partial response
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
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- 2
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- 3
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- 19
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- 28
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- 11
- group Id
- OG009
- value
- 16
- group Id
- OG010
- value
- 10
- group Id
- OG011
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- 14
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
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- OG002
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- 1
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- 0
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- value
- 0
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- OG006
- value
- 4
- group Id
- OG007
- value
- 1
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- OG008
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- 3
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 3
- title
- Progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
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- OG003
- value
- 0
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- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Non-evaluable
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
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- OG003
- value
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- OG004
- value
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- OG005
- value
- 6
- group Id
- OG006
- value
- 51
- group Id
- OG007
- value
- 67
- group Id
- OG008
- value
- 21
- group Id
- OG009
- value
- 33
- group Id
- OG010
- value
- 19
- group Id
- OG011
- value
- 25
- units
- Participants
- description
- Best overall response by independent central review was defined as the proportion of participants who achieved either complete response \[CR\], partial response \[PR\], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD 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. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
- groups
- description
- Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG000
- title
- Dose Escalation: Cohort 1, 0.8 mg/kg
- description
- Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG001
- title
- Dose Escalation: Cohort 2, 1.6 mg/kg
- description
- Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG002
- title
- Dose Escalation: Cohort 3, 3.2 mg/kg
- description
- Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG003
- title
- Dose Escalation: Cohort 4, 5.4 mg/kg
- description
- Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG004
- title
- Dose Escalation: Cohort 5, 6.4 mg/kg
- description
- Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG005
- title
- Dose Escalation: Cohort 6, 8.0 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG006
- title
- Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG007
- title
- Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG008
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG009
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG010
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG011
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Best overall response was assessed in the Intent-to-Treat Analysis Set.
- reporting Status
- POSTED
- time Frame
- From 6 months postdose of last participant up to 3 years 5 months
- title
- Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice