First-in-Human Study of TAK-280 in Participants With Solid Tumors
Phase 1/2
Terminated
NCT05220098
| Condition | Unresectable Locally Advanced or Metastatic Cancer |
|---|
| Phase | Phase 1/2 |
|---|
| Sponsor | Takeda |
|---|
| Status | Terminated |
|---|
| Enrollment | 69 participants |
|---|
| Interventions | TAK-280 |
|---|
| Start date | Apr 21, 2022 |
|---|
| Completion date | Jul 28, 2025 |
|---|
| Results posted | Jul 7, 2026 |
|---|
Summary
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.
Number of Participants With Dose Limiting Toxicities (DLTs)
Cycle 1 (Cycle length=28 days) · Participants
| TAK-280, Dose A | 0 Participants |
|---|
| TAK-280, Dose B | 0 Participants |
|---|
| TAK-280, Dose C | 0 Participants |
|---|
| TAK-280, Dose D | 2 Participants |
|---|
| TAK-280, Dose E | 0 Participants |
|---|
| TAK-280, Dose F | 1 Participants |
|---|
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
From start of study drug administration up to follow-up (up to 37 weeks) · Participants
| TAK-280, Dose A | 2 Participants |
|---|
| TAK-280, Dose B | 1 Participants |
|---|
| TAK-280, Dose C | 3 Participants |
|---|
| TAK-280, Dose D | 5 Participants |
|---|
| TAK-280, Dose E | 5 Participants |
|---|
| TAK-280, Dose F | 5 Participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.