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

Conditions

Advanced or Metastatic Solid Tumors

Brief summary

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.

Jason T. Henry, Anna C. Pavlick, Timothy Humphries, Sunnie S. Y. Kim, Martin Gutierrez et al. (16 authors)

Cancer Research2025-04-251 citations

10.1158/1538-7445.am2025-ct045

Abstract 6746: A B-cell targeted TLR9 agonist antibody conjugate potentiates cancer vaccine efficacy and rejuvenates vaccine responses in the elderly

Maja Bonacorsi, Amy Chen, Ons Harrabi, Min Li, Emma Sangalang et al. (10 authors)

Cancer Research2024-03-221 citations

10.1158/1538-7445.am2024-6746

743 INCLINE-101: preliminary safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TAC-001 (TLR9 agonist conjugated to a CD22 mAb) in patients with advanced or metastatic solid tumors

Cesar A. Perez, Jason T. Henry, Sunnie S. Y. Kim, Anthony B. El-Khoueiry, Martin Gutierrez et al. (12 authors)

Regular and Young Investigator Award Abstracts2023-10-311 citations

10.1136/jitc-2023-sitc2023.0743

756 INCLINE-101, a phase 1/2, open label, dose escalation and expansion study of TAC-001 (a TLR9 agonist conjugated to a CD22 antibody) in patients with select advanced or metastatic solid tumors

Cesar A. Perez, Jason T. Henry, Timothy Humphries, Sunnie S. Y. Kim, Adi Diab et al. (10 authors)

Regular and Young Investigator Award Abstracts2022-11-013 citations

10.1136/jitc-2022-sitc2022.0756

Interventions

DRUGTAC-001

TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Dose-Escalation Stage: RP2D for TAC-001	2-years	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
Dose Expansion: Characterization of ORR for TAC-001	2 years	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
Dose Expansion: Characterization of duration of response for TAC-001	2 years	To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST
Dose Expansion: Characterization of clinical benefit rate for TAC-001	2 years	To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST

Secondary

Measure	Time frame	Description
Terminal Half-Life	2 years	To evaluate the terminal half-life of TAC-001 monotherapy
Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)	2 years	To evaluate the safety of TAC-001 monotherapy through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), as graded by investigators according to CTCAE version 5.0
Evaluation of immunogenicity of TAC-001	2 years	Incidence of antidrug antibodies (ADA) against TAC-001
Clearance of TAC-001	2 years	To evaluate the drug clearance of TAC-001 monotherapy
Maximum Plasma Concentration (Cmax)	2 years	To evaluate the Cmax of TAC-001 monotherapy
Maximum Plasma Concentration (Tmax)	2 years	To evaluate the Tmax of TAC-001 monotherapy
Area Under the Plasma Concentration-Time Curve (AUC)	2 years	To evaluate the AUC of TAC-001 monotherapy

Countries

Australia, United States

Outcome results

None listed