A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma

Rznomics, Inc.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Glioblastoma

Treatments: Combination Product: VGCV; Drug: RZ-001

Study type: Interventional

Funder types: Other

Identifiers

NCT06102525

RZ-001-201

Details and patient eligibility

About

This is a Phase 1/2a, open-label study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 administered in combination with VGCV in subjects with hTERT-positive GBM.

Full description

The study consists of 2 parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2).

Part 1 consists of dose escalation exploring MTD/RP2D for intratumoral (IT) injection.

Part 2 will consist of dose expansion exploring clinical activity for the optimal fixed dose based on the results of Part 1.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males and females
• Histologically-confirmed grade 4 astrocytoma, GBM, per The 2021 WHO Classification of CNS Tumors.
• hTERT positive expression confirmed during the screening period
• ECOG score of ≤ 2
• KPS ≥ 60
• Life expectancy ≥ 3 months

Exclusion criteria

• Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
• Have extracranial metastases of the tumor cells
• Current or history of HIV positive
• Not suitable for inclusion judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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43 participants in 6 patient groups

Part 1 Cohort 1

Experimental group

Description:

RZ-001 Dose 1 and VGCV

Treatment:

Drug: RZ-001

Combination Product: VGCV

Part 1 Cohort 2

Experimental group

Description:

RZ-001 Dose 2 and VGCV

Treatment:

Drug: RZ-001

Combination Product: VGCV

Part 1 Cohort 3

Experimental group

Description:

RZ-001 Dose 3 and VGCV

Treatment:

Drug: RZ-001

Combination Product: VGCV

Part 1 Cohort 4

Experimental group

Description:

RZ-001 Dose 4 and VGCV

Treatment:

Drug: RZ-001

Combination Product: VGCV

Part 1 Cohort 5

Experimental group

Description:

RZ-001 Dose 5 and VGCV

Treatment:

Drug: RZ-001

Combination Product: VGCV

Part 2

Experimental group

Description:

RZ-001 Dose 6 and VGCV

Treatment:

Drug: RZ-001

Combination Product: VGCV