Clinical trial · Interventional
A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
NCT03086239CI-TRIAL-00053048completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rovalpituzumab tesirine | Drug | Rovalpituzumab Tesirine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Rovalpituzumab tesirine
- description
- Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle
- interventionNames
- Drug: Rovalpituzumab tesirine
- type
- EXPERIMENTAL
- label
- Part B: Rovalpituzumab tesirine
- description
- Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).
- interventionNames
- Drug: Rovalpituzumab tesirine
Primary outcomes (1)
- measure
- Number of participants with dose-limiting toxicities (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (SCLC) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic and renal function. Exclusion Criteria: * No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.
References
Publications (2)
- BACKGROUNDUdagawa H, Akamatsu H, Tanaka K, Takeda M, Kanda S, Kirita K, Teraoka S, Nakagawa K, Fujiwara Y, Yasuda I, Okubo S, Shintani M, Kosloski MP, Scripture C, Tamura T, Okamoto I. Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer. Lung Cancer. 2019 Sep;135:145-150. doi: 10.1016/j.lungcan.2019.07.025. Epub 2019 Jul 24. PMID 31446987
- DERIVEDTanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22. PMID 29290251