A Phase 1/2 interventional study of SPGL008 in NMIBC, sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD. (part of 3SBio Inc.) · Phase 1/2, Interventional, and Treatment
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:
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Shenyang Sunshine Pharmaceutical Co., LTD. is the lead sponsor of 40 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Maximum tolerated dose
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Time frame: 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.
Time frame: 7 days
Recommended Phase 2 dose (RP2D)
Time frame: Approximately 2 years.
CR Rate (cohort A)
Time frame: Approximately 4 years.
12-month DFS Rate (cohort B/C)
Time frame: Approximately 12 months
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Time frame: Approximately 4 years.
Duration of CR (DoR)
Time frame: Approximately 4 years.
DFS
Time frame: Approximately 4 years.
Time to cystectomy
Time frame: Approximately 4 years.
Radical cystectomy rate
Time frame: Approximately 4 years.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SPGL008
Non-Muscle Invasive Bladder Neoplasms →
Shenyang Sunshine Pharmaceutical Co., LTD. →