TROPION-Lung01 Study Design and Baseline demographics
Daiichi-Sankyo
First-in-human phase 1 study of R-DXd (NCT04707248)1,2
Subgroup analysis of patients with OVC who received R-DXd at 4.8–8.0 mg/kga
Part A
Dose escalation: R-DXd IV Q3W
Part B
Dose expansion: R-DXD IV Q3W
9.6 mg/kg
8.0 mg/kg
OVC cohort:
4.8 mg/kg
OVC cohort:
6.4 mg/kg
6.4 mg/kg
4.8 mg/kg
3.2 mg/kg
OVC cohort:
5.6 mg/kg
OVC cohort:
8.0 mg/kg
1.6 mg/kg
Enrollment criteria:
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Advanced/metastatic OVC not amenable to SOC therapy
ECOG PS 0-1
Prior taxane and platinum-based chemotherapy
No previous CDH6-targeting agents or ADCs with a linked
topoisomerase I inhibitor
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Patients were not selected based on tumor CDH6 expression
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Key primary objectives:
Safety and tolerability
Determine MTD and RDES for dose expansion
Determine ORR per RECIST v1.1 for dose expansion
Key secondary objectives:
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PK: ADC, total anti-CDH6 antibody, and the DXd payload
Antitumor activity per RECIST v1.1
Immunogenicity
34.8-8.0 mg/kg R-DXd dose cohorts were initially prioritized for dose expansion due to a favorable benefit/risk profile.
ADC, antibody-drug conjugate; CDHB, cadherin 6; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; MTD, maximum tolerated dose; ORR, objective response rate; OVC, ovarian cancer; PK, pharmacokinetics;
Q3W, every 3 weeks; RDE, recommended doses for expansion; RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SOC, standard of care.
1. ClinicalTrials.gov. https://classic.clinicaltrials.gov/ct2/show/NCT04707248. Accessed July 20, 2023; 2. Data on file. Daiichi Sankyo, Inc. DS6000-A-U101 protocol, version 3; 20:20.
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