Clinical trial · Interventional
A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
NCT05399654CI-TRIAL-00079874INCLINE-101unknownPhase 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)
INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously.
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 |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAC-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAC-001 Single-Agent Dose-Escalation Cohorts
- interventionNames
- Drug: TAC-001
Primary outcomes (4)
- measure
- Dose-Escalation Stage: RP2D for TAC-001
- timeFrame
- 2-years
- description
- To identify the recommended dose phase 2 dose (RP2D) for further evaluation of TAC-001 when administered as monotherapy in subjects with advanced or metastatic solid tumors
- measure
- Dose Expansion: Characterization of ORR for TAC-001
- timeFrame
- 2 years
- description
- To evaluate preliminary efficacy of TAC-001 by estimating the overall response rate (ORR; combined complete response \[CR\] and partial response \[PR\]) as assessed by the Investigator per RECIST 1.1 and iRECIST
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically-documented solid tumors. 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 3. Demonstrate adequate organ function. Exclusion Criteria: 1. Prior history of or active malignant disease other than that being treated in this study. 2. Known brain metastases or cranial epidural disease. 3. A known hypersensitivity to the components of the study therapy or its' analogs.
References
Publications (0)
Data not yet available
No reference posted for this study.