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NCT Number: NCT07445308

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.

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

SPGL008

Biological

Biological product

Primary outcomes

  1. Maximum tolerated dose

    Time frame: Approximately 2years

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

  2. Dose-limiting toxicity

    Time frame: 7 days

    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.

  3. Recommended Phase 2 dose (RP2D)

    Time frame: Approximately 2 years.

  4. CR Rate (cohort A)

    Time frame: Approximately 4 years.

  5. 12-month DFS Rate (cohort B/C)

    Time frame: Approximately 12 months

Secondary outcomes

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

    Time frame: Approximately 4 years.

  2. Duration of CR (DoR)

    Time frame: Approximately 4 years.

  3. DFS

    Time frame: Approximately 4 years.

  4. Time to cystectomy

    Time frame: Approximately 4 years.

  5. Radical cystectomy rate

    Time frame: Approximately 4 years.

Study contacts

Contact information is provided by the study sponsor or research team.

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CONTACT

[email protected]

13910688432

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Collaborators

  • Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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