NCT00462488 is a Phase 2 clinical trial of Vicinium in Urinary Bladder Cancer, sponsored by Sesen Bio, Inc..

Who is sponsoring NCT00462488?

NCT00462488 is sponsored by Sesen Bio, Inc..

What drugs are being tested in NCT00462488?

Interventions in NCT00462488: Vicinium.

What condition does NCT00462488 study?

NCT00462488 studies Urinary Bladder Cancer, Bladder Cancer, Bladder Neoplasms, Bladder Tumors.

Is NCT00462488 still recruiting?

NCT00462488 is currently completed. Last updated 30 April 2020.

Are results published for NCT00462488?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-04-30 · How we verify

NCT00462488

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

Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guérin (BCG)

Completed Phase 2 Results posted Last updated 30 April 2020

What this trial tests

Phase 2 trial testing Vicinium in Urinary Bladder Cancer in 46 participants. Completed in 1 October 2009.

Timeline

1 March 2007

Primary endpoint
1 October 2009

1 October 2009

Quick facts

Lead sponsor	Sesen Bio, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	1 March 2007
Primary completion	1 October 2009
Estimated completion	1 October 2009
Sites	21 locations across United States, Canada

Drugs / interventions tested

Vicinium — full drug profile →

Conditions studied

Urinary Bladder Cancer — all drugs for Urinary Bladder Cancer →
Bladder Cancer — all drugs for Bladder Cancer →
Bladder Neoplasms — all drugs for Bladder Neoplasms →
Bladder Tumors — all drugs for Bladder Tumors →

Sponsor

Sesen Bio, Inc. — full company profile →

Who can join

18 and older, any sex, with Urinary Bladder Cancer or Bladder Cancer. 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.

Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy
Time frame: 12 or 13 weeks
Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment

Sponsor's own description

The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).

Publications & conference data

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

Evolution of Escherichia coli Expression System in Producing Antibody Recombinant Fragments.
Sandomenico A, Sivaccumar JP, Ruvo M. · · 2020 · cited 70× · PMID 32878291 · DOI 10.3390/ijms21176324
Pseudomonas Exotoxin-Based Immunotoxins: Over Three Decades of Efforts on Targeting Cancer Cells With the Toxin.
Havaei SM, Aucoin MG, Jahanian-Najafabadi A. · · 2021 · cited 49× · PMID 34976821 · DOI 10.3389/fonc.2021.781800
The combination of immune checkpoint inhibitors and antibody-drug conjugates in the treatment of urogenital tumors: a review insights from phase 2 and 3 studies.
Yu P, Zhu C, You X, Gu W, et al · · 2024 · cited 28× · PMID 38898003 · DOI 10.1038/s41419-024-06837-w
Treating Bladder Cancer: Engineering of Current and Next Generation Antibody-, Fusion Protein-, mRNA-, Cell- and Viral-Based Therapeutics.
Bogen JP, Grzeschik J, Jakobsen J, Bähre A, et al · · 2021 · cited 18× · PMID 34123841 · DOI 10.3389/fonc.2021.672262
Emerging treatments for bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.
Kim HS, Seo HK. · · 2021 · cited 18× · PMID 34085791 · DOI 10.4111/icu.20200602
Bacterial Protein Toxins as Anticancer Agents: Clinical Potential of Pseudomonas and Anthrax Toxins.
Misra R, Gupta R, Nayyar N, Baweja R, et al · · 2025 · cited 1× · PMID 41003524 · DOI 10.3390/toxins17090459
Advances in antibody-drug conjugates for urothelial carcinoma treatment.
Wei J, Tang B, Yan X, Li J, et al · · 2025 · PMID 40985105 · DOI 10.20892/j.issn.2095-3941.2025.0284

Verify or expand the search:

Other recruiting trials for Urinary Bladder Cancer

Currently open trials in the same condition.

NCT07165236 — Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor · recruiting
NCT05644041 — Intravesical Gem/Doce in Patients With NMIBC · Phase 2 · recruiting
NCT05822934 — Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urina · Phase 3 · active not recruiting
NCT05621837 — Quantifying Systemic Immunosuppression to Personalize Cancer Therapy · recruiting
NCT05072600 — Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer · Phase 2 · recruiting

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 NCT00462488 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 21 May 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 Sesen Bio, Inc.
Last refreshed: 30 April 2020

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/NCT00462488.