NCT06181266 (PARADIGM-1) is a Phase 1 clinical trial of ZH9 in NMIBC, sponsored by Prokarium Ltd.

Who is sponsoring NCT06181266?

NCT06181266 is sponsored by Prokarium Ltd.

What drugs are being tested in NCT06181266?

Interventions in NCT06181266: ZH9.

What condition does NCT06181266 study?

NCT06181266 studies NMIBC, High Risk NMIBC, Non Muscle Invasive Bladder Cancer.

Is NCT06181266 still recruiting?

NCT06181266 is currently active, enrolled. Last updated 19 August 2025.

Last reviewed 2025-08-19 · How we verify

NCT06181266: PARADIGM-1

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

A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

Active, enrolled Phase 1 Last updated 19 August 2025

What this trial tests

Phase 1 trial testing ZH9 in NMIBC in 22 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 January 2024

Primary endpoint
30 August 2025

30 July 2027

Quick facts

Lead sponsor	Prokarium Ltd
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	8 January 2024
Primary completion	30 August 2025
Estimated completion	30 July 2027
Sites	4 locations across United States

Drugs / interventions tested

ZH9 — full drug profile →

Conditions studied

NMIBC — all drugs for NMIBC →
High Risk NMIBC — all drugs for High Risk NMIBC →
Non Muscle Invasive Bladder Cancer — all drugs for Non Muscle Invasive Bladder Cancer →

Sponsor

Prokarium Ltd — full company profile →

Who can join

Adults 18 to 99, any sex, with NMIBC or High Risk NMIBC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy. In Part 1, the safety, tolerability, and pharmacology of ZH9 IVI will be evaluated in a single ascending dose (SAD) patient cohort. In Part 2, the safety, tolerability, and pharmacology of ZH9 oral prime followed by ZH9 IVI will be evaluated in 2 patient cohorts at the doses and schedule established in Part 1. In Part 3, the safety, pharmacology, and clinical efficacy of ZH9 will be further evaluated in 2 expansion cohorts of patients with recurrent intermediate- and high-risk NMIBC.

Publications & conference data

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

Engineering Salmonella as an immune-metabolic modulator of the tumor microenvironment.
Varsha KK, Dwidar M. · · 2026 · PMID 41820175 · DOI 10.1016/j.tibtech.2026.01.010
Characterization of Ty21a immunostimulatory effects in the mouse bladder.
Polak L, Hojeij R, Cesson V, Haefliger JA, et al · · 2025 · PMID 41383612 · DOI 10.3389/fimmu.2025.1629462
Programmable cancer treatments: Engineering biology approaches for living cures.
Biarnes Carrera M, Sevko A, Glanville N, Deban L. · · 2024 · PMID 39473536 · DOI 10.1049/enb2.12032

Verify or expand the search:

Other recruiting trials for NMIBC

Currently open trials in the same condition.

NCT06735287 — A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer · NA · recruiting
NCT06889623 — Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer · NA · recruiting
NCT06991868 — A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Mi · recruiting
NCT05943379 — RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects · Phase 2 · recruiting

Other Prokarium Ltd trials

Trials by the same sponsor.

NCT04349553 — Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine · 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 NCT06181266 (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 Prokarium Ltd
Last refreshed: 19 August 2025

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/NCT06181266.

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