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The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

NCT07445308 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-03

No results posted yet for this study

Summary

The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer.

The main questions it aims to answer are:

1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To
2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

Conditions

Interventions

BIOLOGICAL

SPGL008

Biological product

Sponsors & Collaborators

  • Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Shenyang Sunshine Pharmaceutical 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
2026-03-12
Primary Completion
2028-11-21
Completion
2029-12-21

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Entities

Diseases

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 NCT07445308 on ClinicalTrials.gov