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

NCT ID: NCT06181266

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2027-07-30

Brief Summary

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.

Conditions

NMIBC; High Risk NMIBC; Non Muscle Invasive Bladder Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Level 1 - ZH9

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

Group Type: EXPERIMENTAL

ZH9

Intervention Type: DRUG

ZH9 is a live attenuated S. enterica serovar Typhi ZH9 \[Ty2 ΔaroC ΔssaV\]), a differentiated novel microbial immunotherapy.

Dose Level 2 - ZH9

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

Group Type: EXPERIMENTAL

ZH9

Intervention Type: DRUG

ZH9 is a live attenuated S. enterica serovar Typhi ZH9 \[Ty2 ΔaroC ΔssaV\]), a differentiated novel microbial immunotherapy.

Dose Level 3 - ZH9

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

Group Type: EXPERIMENTAL

ZH9

Intervention Type: DRUG

ZH9 is a live attenuated S. enterica serovar Typhi ZH9 \[Ty2 ΔaroC ΔssaV\]), a differentiated novel microbial immunotherapy.

Dose Level 4 - ZH9

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

Group Type: EXPERIMENTAL

ZH9

Intervention Type: DRUG

ZH9 is a live attenuated S. enterica serovar Typhi ZH9 \[Ty2 ΔaroC ΔssaV\]), a differentiated novel microbial immunotherapy.

Interventions

ZH9

ZH9 is a live attenuated S. enterica serovar Typhi ZH9 \[Ty2 ΔaroC ΔssaV\]), a differentiated novel microbial immunotherapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Histologically documented recurrence of NMIBC
• BCG unresponsive (BCG naïve patients may be enrolled if they have received at least 1 line of adequate intravesical standard of care (SOC) treatment and are either not candidates for BCG or do not have access to BCG (e.g., BCG shortage))
• Eastern Cooperative Oncology Group Performance Status 0-1
• Adequate organ and marrow function
• Highly effective contraception if risk of conception exists.
• A female participant is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception.

Exclusion Criteria

• Received treatment with any local or systemic antineoplastic therapy within 3 weeks or 5× the plasma half-life prior to first dose of ZH9
• Major surgery or radiation within the 3 weeks prior to Screening (TURBT is not considered major surgery)
• Concurrent urinary tract infection or history of clinically significant polyuria
• Symptoms consistent with typhoid
• Evidence of infection within 2 weeks of the first dose of ZH9
• Significant 12-lead electrocardiogram abnormalities
• History of malignancy within the previous 12 months
• History of allogeneic tissue/solid organ transplant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prokarium Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josefin-Beate Holz, MD

Role: STUDY_DIRECTOR

Prokarium Ltd

Locations

Michael G. Oefelein Clinical Trials

Bakersfield, California, United States

Duke Health-Duke Cancer Center

Durham, North Carolina, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Urology San Antonio Medical Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PRK-23101

Identifier Type: -

Identifier Source: org_study_id