Clinical trial · Interventional
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
A Non-Randomized, Open-Label, Multi-Center Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Japanese Subjects With Malignant Glioma
NCT02590263CI-TRIAL-00046952completedPhase 1 / Phase 2ClinicalTrials.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 study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-414 | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
| Whole Brain Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A of Phase 1 portion
- description
- ABT-414 administered every other weeks monotherapy
- interventionNames
- Drug: ABT-414
- type
- EXPERIMENTAL
- label
- Phase 2 portion
- description
- ABT-414 administered every other weeks in combination with temozolomide
- interventionNames
- Drug: Temozolomide
- Drug: ABT-414
- type
- EXPERIMENTAL
- label
- Arm C of Phase 1 portion
- description
- ABT-414 administered every other weeks in combination with radiation and temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese participants with WHO grade III or IV malignant glioma * 70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion * 80 or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion * Adequate bone marrow function * Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2 portion * Histologically proven newly diagnosed malignant glioma in Arm B and Arm C of Phase 1 portion * Participants must have confirmed EGFR amplification by central lab in Phase 2 portion Exclusion Criteria: * Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2 portion) * Anti-cancer treatment prior to study Day 1 for Arm B and Arm C of Phase 1 portion * Participant has received prior treatment with bevacizumabor, EGFR therapy in Arm A of Phase 1 portion and Phase 2 portion, or for recurrent glioblastoma in Phase 2 portion * Participant has a history of major immunologic reaction to any Immunoglobulin G containing agents or component of ABT-414.
References
Publications (1)
- DERIVEDNarita Y, Muragaki Y, Kagawa N, Asai K, Nagane M, Matsuda M, Ueki K, Kuroda J, Date I, Kobayashi H, Kumabe T, Beppu T, Kanamori M, Kasai S, Nishimura Y, Xiong H, Ocampo C, Yamada M, Mishima K. Safety and efficacy of depatuxizumab mafodotin in Japanese patients with malignant glioma: A nonrandomized, phase 1/2 trial. Cancer Sci. 2021 Dec;112(12):5020-5033. doi: 10.1111/cas.15153. Epub 2021 Oct 30. PMID 34609773