A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors (INCLINE-101)

Tallac Therapeutics

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: TAC-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05399654

INCLINE-101

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

TAC-001 Single-Agent Dose-Escalation Cohorts

Experimental group

Treatment:

Drug: TAC-001