MedTrace Logo

A Clinical Study of GO321 in Patients With Advanced Solid Tumors

NCT07748117 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-08-05

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the safety and tolerability of GO321 recombinant oncolytic virus injection, and if GO321 recombinant oncolytic virus injection works to treat advanced solid tumors in adults whose cancers have progressed after standard-of-care therapy. It will also learn about the pharmacokinetic features, viral shedding, immunogenicity of GO321, immune markers, and genomic and proteomic changes in patients. The main questions it aims to answer are: What safety issues and tolerability limitations do participants experience when receiving GO321 via intratumoral or intracavitary injection? Does GO321 have preliminary anti-tumor efficacy against advanced solid tumors resistant to standard treatment? What changes take place in viral distribution, viral shedding, immunity, blood immune markers, tumor or blood genomics and proteomics after GO321 administration? Researchers will assess different doses and dosing schedules of GO321 given by intratumoral or intracavitary injection across two study phases to find a suitable administration dose and regimen and verify the study endpoints.

Participants will:

Receive either a single injection of GO321 at different dose levels (in Part 1) or repeated GO321 injections at the recommended Phase 2 dose (in Part 2) by intratumoral or intracavitary routes; Complete scheduled hospital visits to undergo laboratory tests, imaging examinations and biological sample collection; Have their safety indicators, anti-tumor response, viral parameters, immune indicators and molecular profiles tracked throughout the study.

Conditions

  • Solid Tumor Malignancies

Interventions

DRUG

GO321

Part 1: 3+3 Single-Dose Escalation Phase： This phase adopts a standard 3+3 dose-escalation design. GO321 is administered via intratumoral or intracavitary single injection, with the dose escalating progressively within the range of 3.0E+07 PFU to 1.0E+09 PFU. Each dose cohort will enroll 3 subjects, and all enrolled subjects will receive a single initial administration of the study drug. Part 2: Multiple-Dose Expansion Phase： This expansion phase is conducted at the recommended dose (RD) level, aiming to explore the preliminary anti-tumor efficacy of GO321 in specific tumor types. A total of 9 subjects with specific tumor types will be enrolled in this cohort. GO321 is administered via intratumoral or intracavitary injection on a once-weekly (QW) or once-every-two-weeks (Q2W) dosing schedule.

Sponsors & Collaborators

  • GeneSail Biotech (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07748117 on ClinicalTrials.gov