Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPGL008 · 2 trials · 2 indications
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
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.
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
| Arm | Type | Description |
|---|---|---|
| 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 |
| dose level 1 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 2 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 3 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 4 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 5 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 6 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 7 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 8 of SPGL008 （Intravenous administration） | EXPERIMENTAL | - |
| dose level 1 of SPGL008 （Subcutaneous administration） | EXPERIMENTAL | - |
| dose level 2 of SPGL008 （Subcutaneous administration） | EXPERIMENTAL | - |
| dose level 3 of SPGL008 （Subcutaneous administration） | EXPERIMENTAL | - |
| dose level 4 of SPGL008 （Subcutaneous administration） | EXPERIMENTAL | - |
| dose level 5 of SPGL008 （Subcutaneous administration） | EXPERIMENTAL | - |
| dose level 6 of SPGL008 （Subcutaneous administration） | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SPGL008 | BIOLOGICAL | Biological product |
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...
SPGL008 is an investigational small molecule being developed for the treatment of advanced malignant tumors and non-muscle invasive bladder cancer (NMIBC). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
SPGL008 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.
SPGL008 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 1 trials are designed to evaluate its safety, tolerability, and preliminary efficacy in patients with advanced malignant tumors and NMIBC.
SPGL008 is being studied in two Phase 1 clinical trials. NCT07038005 is a study in patients with advanced malignant tumors, currently recruiting in China with an enrollment of 96 participants. NCT07445308 is a planned study in patients with NMIBC, evaluating SPGL008 alone or in combination with BCG, with an enrollment of 120 participants.
Yes, SPGL008 is being studied in combination with BCG in a Phase 1 clinical trial for patients with non-muscle invasive bladder cancer (NMIBC). The trial aims to evaluate the safety, tolerability, and preliminary efficacy of SPGL008 alone or in combination with BCG.