NCT01296581 is a Phase 1 clinical trial of X-82 in Advanced Solid Tumors, sponsored by Tyrogenex.

Who is sponsoring NCT01296581?

NCT01296581 is sponsored by Tyrogenex.

What drugs are being tested in NCT01296581?

Interventions in NCT01296581: X-82.

What condition does NCT01296581 study?

NCT01296581 studies Advanced Solid Tumors.

Is NCT01296581 still recruiting?

NCT01296581 is currently completed. Last updated 9 February 2022.

Last reviewed 2022-02-09 · How we verify

NCT01296581

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I, First in Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X-82 in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 9 February 2022

What this trial tests

Phase 1 trial testing X-82 in Advanced Solid Tumors in 52 participants. Completed in 1 January 2017.

Timeline

1 February 2011

Primary endpoint
1 January 2014

1 January 2017

Quick facts

Lead sponsor	Tyrogenex
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	1 February 2011
Primary completion	1 January 2014
Estimated completion	1 January 2017
Sites	1 location across United States

Drugs / interventions tested

X-82 — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Tyrogenex — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximum Tolerated Dose
Time frame: 12 months
To determine the maximum tolerated dose (MTD) of X-82 as a single agent.

Sponsor's own description

The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a single agent.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

New strategies in squamous cell carcinoma of the lung: identification of tumor drivers to personalize therapy.
Gold KA, Wistuba II, Kim ES. · · 2012 · cited 25× · PMID 22461458 · DOI 10.1158/1078-0432.ccr-11-2055
Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Vorolanib in Patients with Advanced Solid Tumors.
Bendell JC, Patel MR, Moore KN, Chua CC, et al · · 2019 · cited 18× · PMID 30478190 · DOI 10.1634/theoncologist.2018-0740

Verify or expand the search:

Other trials of X-82

Trials testing the same drug.

NCT02348359 — X-82 to Treat Age-related Macular Degeneration · Phase 2 · terminated
NCT01784861 — VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors · Phase 1, PHASE2 · terminated

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Tyrogenex trials

Trials by the same sponsor.

NCT02348359 — X-82 to Treat Age-related Macular Degeneration · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01296581 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tyrogenex
Last refreshed: 9 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01296581.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing