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ACTIVE NOT RECRUITING Phase 1

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

NCT05399654 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG TAC-001

Study Locations (12)

Colorado

  • University of Colorado — Aurora
  • Sarah Cannon Research Institute (SCRI)- Denver — Denver

Florida

  • AdventHealth Cancer Institute — Orlando
  • Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC — Orlando

Texas

  • The University of Texas MD Anderson Cancer Center — Houston
  • NEXT Oncology — Irving

California

  • University of Southern California (USC) — Los Angeles

New Jersey

  • John Theurer Cancer Center — Hackensack

New York

  • Weill Cornell Medicine- NYU Clinical Cancer Center — New York

Tennessee

  • West Cancer Center & Research Institute — Germantown

Virginia

  • NEXT Oncology- Virginia — Fairfax

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2022-06-28
Est. Completion 2026-05-19
Phase Phase 1

Sponsor

Tallac Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05399654

The ClinicalTrials.gov registry entry for NCT05399654 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tallac Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which TAC-001 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05399654 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Colorado, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05399654 about?

NCT05399654 is a clinical study titled "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.

What is the current status of trial NCT05399654?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2022-06-28. Estimated completion is 2026-05-19.

What conditions does trial NCT05399654 study?

This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05399654?

The interventions under investigation include: TAC-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05399654?

This trial is sponsored by Tallac Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05399654 being conducted?

This trial has 12 study locations across California, Colorado, Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial