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MELANOMA: PHASE 1: TOLL-LIKE RECEPTOR AGONIST AB CONJUGATE: INCLINE-101

A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors

Title
Tallac Incline-101 phase I metastatic solid tumors
Study Title

A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors

Site Link
Malignancy
Melanoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Any
Investigational Agent
TAC-001
Drug Class
T-cell receptor agonist antibody drug conjugate
PI
Dan Vaena, MD
Sponsor
Tallac Pharmaceuticals
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details

CURRENTLY ONLY THE MELANOMA COHORT IS ENROLLING

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.
Objective

Primary:

  • RP2D
  • ORR
  • DoR
  • CBR

Secondary

  • Safety
  • PK
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Histologic documentation
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X