Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05399654 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Tallac Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 12
- Study locations
NCT05399654: Active Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Tallac Therapeutics.
NCT05399654 is a Phase 1 study of Advanced or Metastatic Solid Tumors that is active but no longer recruiting, run by Tallac Therapeutics. The registered enrollment target is 72 participants, below the 233-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (69% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05399654, a Phase 1 study of Advanced or Metastatic Solid Tumors, is active but no longer recruiting, sponsored by Tallac Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 12
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2026-05-19 |
| Phase | Phase 1 |
What the registry record for NCT05399654 still lists
NCT05399654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 233-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (69% lower).
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.
NCT05399654 lists 12 locations in 9 states (Colorado, Florida, Texas).
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.
What interventions are being tested in trial NCT05399654?
The interventions under investigation include: TAC-001 (DRUG).
Who is sponsoring clinical trial NCT05399654?
This trial is sponsored by Tallac Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced or Metastatic Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05399654's enrollment target sits among peer trials
72 19th of 19 higher than 1 of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
RECRUITING · Phase 1
-
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI