NCT00419328 is a Phase 1 clinical trial of NGR-hTNF in Advanced Solid Tumors, sponsored by AGC Biologics S.p.A..

Who is sponsoring NCT00419328?

NCT00419328 is sponsored by AGC Biologics S.p.A..

What drugs are being tested in NCT00419328?

Interventions in NCT00419328: NGR-hTNF.

What condition does NCT00419328 study?

NCT00419328 studies Advanced Solid Tumors.

Is NCT00419328 still recruiting?

NCT00419328 is currently completed. Last updated 19 July 2022.

Last reviewed 2022-07-19 · How we verify

NCT00419328

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

NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose

Completed Phase 1 Last updated 19 July 2022

What this trial tests

Phase 1 trial testing NGR-hTNF in Advanced Solid Tumors in 16 participants. Completed in 1 September 2007.

Timeline

1 March 2005

Primary endpoint
1 September 2007

1 September 2007

Quick facts

Lead sponsor	AGC Biologics S.p.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 March 2005
Primary completion	1 September 2007
Estimated completion	1 September 2007
Sites	1 location across Italy

Drugs / interventions tested

NGR-hTNF — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

AGC Biologics S.p.A. — 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.

To verify safety of escalating doses of NGR-hTNF
Time frame: during and following the treatment
To verify safety of escalating doses of NGR-hTNF

Sponsor's own description

The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Vascular Disruption Therapy as a New Strategy for Cancer Treatment.
Gómez-Escudero J, Berlana-Galán P, Guerra-Paes E, Torre-Cea I, et al · · 2025 · cited 1× · PMID 41155375 · DOI 10.3390/ijms262010085

Verify or expand the search:

Other trials of NGR-hTNF

Trials testing the same drug.

NCT03536039 — RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor · Phase 2 · completed
NCT00483509 — Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma · Phase 2 · completed
NCT00305084 — Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors · Phase 1 · completed

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 AGC Biologics S.p.A. trials

Trials by the same sponsor.

NCT04097301 — Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma · Phase 1, PHASE2 · terminated
NCT00914628 — Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia · Phase 3 · terminated
NCT00483509 — Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma · Phase 2 · completed
NCT00305084 — Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors · Phase 1 · completed

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 NCT00419328 (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 AGC Biologics S.p.A.
Last refreshed: 19 July 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/NCT00419328.

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