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NCT Number: NCT05399654

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Site, Nedlands, Western Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically-documented solid tumors.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Demonstrate adequate organ function.

Exclusion criteria

  • Prior history of or active malignant disease other than that being treated in this study.
  • Known brain metastases or cranial epidural disease.
  • A known hypersensitivity to the components of the study therapy or its' analogs.

Treatment and study plan

TAC-001

Drug

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

Primary outcomes

  1. Dose-Escalation Stage: RP2D for TAC-001

    Time frame: 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

  2. Dose Expansion: Characterization of ORR for TAC-001

    Time frame: 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

  3. Dose Expansion: Characterization of duration of response for TAC-001

    Time frame: 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

  4. Dose Expansion: Characterization of clinical benefit rate for TAC-001

    Time frame: 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 outcomes

  1. Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 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

  2. Maximum Plasma Concentration (Cmax)

    Time frame: 2 years

    To evaluate the Cmax of TAC-001 monotherapy

  3. Maximum Plasma Concentration (Tmax)

    Time frame: 2 years

    To evaluate the Tmax of TAC-001 monotherapy

  4. Area Under the Plasma Concentration-Time Curve (AUC)

    Time frame: 2 years

    To evaluate the AUC of TAC-001 monotherapy

  5. Terminal Half-Life

    Time frame: 2 years

    To evaluate the terminal half-life of TAC-001 monotherapy

  6. Clearance of TAC-001

    Time frame: 2 years

    To evaluate the drug clearance of TAC-001 monotherapy

  7. Evaluation of immunogenicity of TAC-001

    Time frame: 2 years

    Incidence of antidrug antibodies (ADA) against TAC-001

Sponsors and collaborators

Lead sponsor

Tallac Therapeutics

Industry

Registry information

Official 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

Acronym: INCLINE-101

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2022
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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