Phase 1
N=27
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Advanced Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02564900 ↗Enrolled (actual)
27
Serious AEs
25.0%
Results posted
Jun 2021
Primary outcome: Primary: Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) — 0; 33.3; 0; 83.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- DS-8201a (DP1) (Drug); DS-8201a (DP2) (Drug); DS-8201a (DP) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) |
0; 33.3; 0; 83.3; 33.3; 50.0 | — |
| SECONDARY Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) |
100.0; 100.0; 66.7; 100.0; 100.0; 100.0 | — |
| SECONDARY Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) |
12.7; 13.6; NA; 10.4; 5.6; 6.9 | — |
| SECONDARY Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) |
2.7; 2.8; 2.6; 2.7; 1.6; 2.2 | — |
| SECONDARY Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) |
13.7; 14.1; NA; 11.1; 4.3; 8.2 | — |
| SECONDARY Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) |
NA; NA; NA; 19.7; 18.9; 26.2 | — |
| SECONDARY Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose |
51.7; 116; 325; 544; 901; 996 | — |
| SECONDARY Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose |
22.9; 36.2; 78.2; 127; 181; 221 | — |
| SECONDARY Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose |
1.95; 4.03; 4.12; 2.02; 2.06; 1.97 | — |
| SECONDARY Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum DS-8201a Following First Dose |
2.18; 3.07; 4.23; 6.03; 7.33; 6.44 | — |
| SECONDARY Overview of Treatment-emergent Adverse Events |
3; 3; 3; 6; 6; 6 | — |
Summary
This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group performance status( PS) of 0 or 1.
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%
Part 1:
- Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2a:
- Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Treated with ado-trastuzumab emtansine (T-DM1)
Part 2b:
- Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Treated with trastuzumab
Part 2c:
- Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2d:
- Satisfy at least one of the following criteria
- Advanced/unresectable or metastatic solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2e:
- Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression only)
Exclusion Criteria
- Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
- Has a medical history of myocardial infarction or unstable angina.
- Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
- Has a medical history of clinically significant lung diseases
Data sourced from ClinicalTrials.gov (NCT02564900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.