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 | Not Yet Recruiting Phase 1

• 1 other identifier: SPGL008-102
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

NMIBC

Outcome Measures

Primary Outcomes (5)

• Maximum tolerated dose

  MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

  Approximately 2years

• Dose-limiting toxicity

  DLT will be defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug that occurred within the 7 days of first treatment.

  7 days

• Recommended Phase 2 dose (RP2D)

  Approximately 2 years.

• CR Rate (cohort A)

  Approximately 4 years.

• 12-month DFS Rate (cohort B/C)

  Approximately 12 months

Secondary Outcomes (5)

• Treatment-Related Adverse Events as assessed by CTCAE v5.0

  Approximately 4 years.

• Duration of CR (DoR)

  Approximately 4 years.

• DFS

  Approximately 4 years.

• Time to cystectomy

  Approximately 4 years.

• Radical cystectomy rate

  Approximately 4 years.

Study Arms (1)

SPGL008

EXPERIMENTAL

Phase I：Phase Ia and Ib： Phase Ia include SPGL008 dose escalation and expansion; Phase Ib ： SPGL008 in combination with BCG dose escalation and expansion Phase II：SPGL008 in combination with BCG dose expansion in NMIBC

Biological: SPGL008

Interventions

SPGL008 BIOLOGICAL

Biological product

SPGL008

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
• Age ≥ 18 years old, gender is not limited;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
• Expected survival time ≥ 2 years;
• High-risk NMIBC diagnosed by previous pathological biopsy
• ineligible or unwilling to undergo radical cystectomy;
• The level of organ function is good.

You may not qualify if:

• Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
• Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
• Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
• Serious infection within 4 weeks before the first administration, or undefined fever\>38.5 ℃ during screening/before the first administration;
• Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
• Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead
• Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

zhisong he

CONTACT

13910688432; wyj7074@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 3, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): November 21, 2028
• Study Completion (Estimated): December 21, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share