NCT03636256 is a Phase 1, PHASE2 clinical trial of NanoDoce (direct injection) in Bladder Cancer, sponsored by NanOlogy, LLC.

Who is sponsoring NCT03636256?

NCT03636256 is sponsored by NanOlogy, LLC.

What drugs are being tested in NCT03636256?

Interventions in NCT03636256: NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care, NanoDoce (intravesical instillation) - Induction and Maintenance Instillations.

What condition does NCT03636256 study?

NCT03636256 studies Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer, Urogenital Neoplasms, Urologic Neoplasms, Urologic Cancer, Malignant Tumor of the Urinary Bladder, Cancer of the Bladder.

Is NCT03636256 still recruiting?

NCT03636256 is currently completed. Last updated 14 August 2023.

Are results published for NCT03636256?

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

Last reviewed 2023-08-14 · How we verify

NCT03636256

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

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Completed Phase 1, PHASE2 Results posted Last updated 14 August 2023

What this trial tests

Phase 1, PHASE2 trial testing NanoDoce (direct injection) in Bladder Cancer in 36 participants. Completed in 2 November 2021.

Timeline

2 April 2019

Primary endpoint
2 November 2021

2 November 2021

Quick facts

Lead sponsor	NanOlogy, LLC
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	2 April 2019
Primary completion	2 November 2021
Estimated completion	2 November 2021
Sites	5 locations across United States

Drugs / interventions tested

NanoDoce (direct injection) — full drug profile →
NanoDoce (intravesical instillation) - Visit 2 Instillation — full drug profile →
Institutional Standard of Care
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations — full drug profile →

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →
Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
Urinary Bladder Neoplasm — all drugs for Urinary Bladder Neoplasm →
Urinary Bladder Cancer — all drugs for Urinary Bladder Cancer →

Sponsor

NanOlogy, LLC — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer or Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) Primary · Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)

Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

Group	Value	95% CI
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL	3
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL	3
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL	3
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL	9
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL	1
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL	5
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL	2
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL	1
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL	6

Recurrence Free Survival (RFS) Secondary · At Months 6, 9, and 12

No evidence of tumor recurrence or disease progression

Group	Value	95% CI
Non-Muscle Invasive Bladder Cancer - 0.75 mg/mL NanoDoce Injection Cohort	5.1	± 1.79
Non-Muscle Invasive Bladder Cancer - 1.5 mg/mL NanoDoce Injection Cohort	6.7	± 3.10
Non-Muscle Invasive Bladder Cancer - 2.5 mg/mL NanoDoce Injection Cohort	4.7	± 1.10
Non-Muscle Invasive Bladder Cancer - 3.75 NanoDoce Injection Cohort	9.6	± 3.31

Disease Progression Secondary · Day 45

Disease progression at Day 45 derived from cytology and biopsy assessments

Group	Value	95% CI
Muscle Invasive Bladder Cancer - 0.75 mg/mL NanoDoce Injection Cohort	2
Muscle Invasive Bladder Cancer - 1.5 mg/mL NanoDoce Injection Cohort	1
Muscle Invasive Bladder Cancer - 2.5 mg/mL NanoDoce Injection Cohort	0
Muscle Invasive Bladder Cancer - 3.75 NanoDoce Injection Cohort	1
Muscle Invasive Bladder Cancer Subset (Group 2 Subset) - 3.75/mg/mL NanoDoce Injection	0

Adverse events — posted to ClinicalTrials.gov

Time frame: AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL

Serious: 0/4 (0%)

Deaths: 0/4

Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL

Serious: 0/3 (0%)

Deaths: 0/3

Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL

Serious: 0/3 (0%)

Deaths: 0/3

Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL

Serious: 1/9 (11%)

Deaths: 0/9

Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL

Serious: 0/1 (0%)

Deaths: 0/1

Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL

Serious: 1/5 (20%)

Deaths: 0/5

Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL

Serious: 0/2 (0%)

Deaths: 0/2

Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL

Serious: 0/2 (0%)

Deaths: 0/2

Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL

Serious: 1/7 (14%)

Deaths: 0/7

Serious adverse events (4 terms)

Reaction	System	Non-Muscle Invasive Bladde…	Non-Muscle Invasive Bladde…	Non-Muscle Invasive Bladde…	Non-Muscle Invasive Bladde…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Bladder Perforation	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Chest Pain	General disorders	—	—	—	—	—	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—

Other adverse events (108 terms — click to expand)

Reaction	System	Non-Muscle Invasive Bladde…	Non-Muscle Invasive Bladde…	Non-Muscle Invasive Bladde…	Non-Muscle Invasive Bladde…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…	Muscle Invasive Bladder Ca…
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Polyuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Bladder pain	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Micturition urgency	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Urinary incontinence	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—
Abdominal Pain Lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal Pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dry Mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gingival Bleeding	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oral Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Tongue Discoloration	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Chest Pain	General disorders	—	—	—	—	—	—	—	—	—
Disease Progression	General disorders	—	—	—	—	—	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—	—	—	—	—	—
Corona Virus Infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Herpes Virus Infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Oral Candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Nephrolithiasis, Bladder Perforation, Chest Pain, Haematemesis.

Data from ClinicalTrials.gov NCT03636256 adverse events section.

Sponsor's own description

This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation. All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.

Publications & conference data

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

Nanoparticles in the clinic: An update post COVID-19 vaccines.
Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
Local Injection of Submicron Particle Docetaxel is Associated with Tumor Eradication, Reduced Systemic Toxicity and an Immunologic Response in Uro-Oncologic Xenografts.
Maulhardt HA, Hylle L, Frost MV, Tornio A, et al · · 2019 · cited 14× · PMID 31022918 · DOI 10.3390/cancers11040577
The State of the Art of Theranostic Nanomaterials for Lung, Breast, and Prostate Cancers.
Freitas LF, Ferreira AH, Thipe VC, Varca GHC, et al · · 2021 · cited 11× · PMID 34685018 · DOI 10.3390/nano11102579
New Roadmaps for Non-muscle-invasive Bladder Cancer With Unfavorable Prognosis.
Pane K, Mirabelli P, Coppola L, Illiano E, et al · · 2020 · cited 11× · PMID 32850635 · DOI 10.3389/fchem.2020.00600
Submicron particle docetaxel intratumoral injection in combination with anti-mCTLA-4 into 4T1-Luc orthotopic implants reduces primary tumor and metastatic pulmonary lesions.
Maulhardt H, Marin A, Hesseltine H, diZerega G. · · 2021 · cited 9× · PMID 34331595 · DOI 10.1007/s12032-021-01555-1
Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer.
Chang E, Hahn NM, Lerner SP, Fallah J, et al · · 2023 · cited 7× · PMID 38993184 · DOI 10.3233/blc-230056
Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune-mediated tumoricidal effects: preclinical and clinical studies.
Maulhardt H, Verco S, Baltezor M, Marin A, et al · · 2023 · cited 7× · PMID 36058988 · DOI 10.1007/s13346-022-01226-2
Phase 1/2 Trial Results of a Large Surface Area Microparticle Docetaxel for the Treatment of High-Risk Nonmuscle-Invasive Bladder Cancer.
Kates M, Mansour AM, Lamm DL, Shore N, et al · · 2022 · cited 7× · PMID 35574612 · DOI 10.1097/ju.0000000000002778

Verify or expand the search:

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting

Other NanOlogy, LLC trials

Trials by the same sponsor.

NCT04314895 — Trial of NanoPac Intratumoral Injection in Lung Cancer · Phase 2 · completed
NCT04221828 — Trial of NanoPac Focal Therapy for Prostate Cancer · Phase 2 · terminated
NCT03101358 — Study of Topical SOR007 Ointment for Cutaneous Metastases · Phase 1, PHASE2 · completed
NCT03077685 — Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma · Phase 2 · completed
NCT03188991 — Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms · Phase 2 · 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 NCT03636256 (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 NanOlogy, LLC
Last refreshed: 14 August 2023

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/NCT03636256.

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