Clinical trial · Interventional
First-in-Human Study of TAK-280 in Participants With Solid Tumors
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to limited anti-cancer activity
Summary
Brief summary (as posted)
The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies. Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days. After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.
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 |
|---|---|---|---|
| Unresectable Locally Advanced or Metastatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAK-280 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose-escalation Phase: TAK-280
- description
- Participants will receive TAK-280 intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
- interventionNames
- Drug: TAK-280
- type
- EXPERIMENTAL
- label
- Cohort-expansion Phase: TAK-280 High or low Dose
- description
- Participants will receive either TAK-280 high or low dose in one selected indication and only one dose level of TAK-280 in the remaining indications as determined from the dose-escalation phase of the study in 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
- interventionNames
- Drug: TAK-280
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age greater than or equal to (\>=)18 years or \>= the local legal age of majority, as applicable. * Criteria for disease state in dose escalation and cohort expansion. 1. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers. 2. Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms. * Eastern Cooperative Oncology Group performance status (less than or equal to \[\<=\]) 1. * Measurable disease per RECIST V1.1 by investigator except for participants with mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was \>=6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion. Exclusion Criteria * History of known autoimmune disease. * Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280. * Unhealed wounds from surgery or injury. * Ongoing or active infection of Grade \>=2. * Oxygen saturation less than (\<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment. * Inflammatory process that has not resolved for \>= 4 weeks before the first dose of study drug. Participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration. * Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. * Known hypersensitivity to TAK-280 or any excipient.
References
Publications (0)
Data not yet available