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.

Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of SPGL008 as Monotherapy or in Combination With BCG in Patients With Non-Muscle-Invasive Bladder Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NMIBC
• Intervention / Treatment: Biological: SPGL008

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: zhisong he; Phone Number: 13910688432; Email: wyj7074@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
2. 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;
3. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
4. Serious infection within 4 weeks before the first administration, or undefined fever>38.5 ℃ during screening/before the first administration;
5. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
6. Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPGL008; 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; Biological product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended Phase 2 dose (RP2D)		Approximately 2 years.
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
CR Rate (cohort A)		Approximately 4 years.
12-month DFS Rate (cohort B/C)		Approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
• Collaborators: Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 12, 2026
• Primary Completion (Estimated): November 21, 2028
• Study Completion (Estimated): December 21, 2029

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: SPGL008-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No