Clinical trial

A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, and Efficacy of RZ-001 in Combination With Valganciclovir in Subjects With Glioblastoma

Name

RZ-001-201

Description

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.

Trial arms

Trial start

2023-10-01

Estimated PCD

2029-03-01

Trial end

2029-05-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

RZ-001

Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene

Arms:

Part 1 Cohort 1, Part 1 Cohort 2, Part 1 Cohort 3, Part 1 Cohort 4, Part 1 Cohort 5, Part 2

Other names:

Ad-ECRT-122T

VGCV

VGCV, used in a subject after RZ-001 administration, is a nucleoside analog that is metabolized by HSV-tk and other cellular kinases to form the cytotoxic nucleotide analog ganciclovir triphosphate. An approved oral VGCV will be used in the proposed clinical study of RZ-001.

Arms:

Part 1 Cohort 1, Part 1 Cohort 2, Part 1 Cohort 3, Part 1 Cohort 4, Part 1 Cohort 5, Part 2

Other names:

Valganciclovir

Size

Primary endpoint

Number of dose limiting toxicities (DLTs)

Day 1 to Day 28

Maximum tolerated dose (MTD) or maximum administered dose (MAD) dose(MAD) and select the recommended Phase 2 dose (RP2D) of RZ-001 in combination with VGCV

Day 1 to Day 28

Number of participants with treatment-related adverse events as assessed by NCI-CTCAE

Day 1 to Day 28

Number of participants with significant laboratory abnormalities as assessed by NCI-CTCAE

Day 1 to Day 28

Overall survival (OS)

Day 1 to Day 15

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ESTIMATED'}}

Updated at

2023-10-26

1 organization

2 products

1 indication

Organization

Product

Indication

Product