Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Chemophase · 2 trials · 2 indications
The MTD was defined as the maximum dose level at which no more than two of six participants experienced dose-limiting toxicities (DLT). DLT was defined as any of the following: * Plasma MMC concentration greater than or equal to (\>=) 100 nanograms (ng)/milliliter (mL) * Adverse event (AE) with a Common Toxicity Criteria (CTC) grade greater than or equal to 3 * New, treatment-emergent diagnosis of bladder fibrosis.
DLT was defined as any of the following: * Plasma MMC concentration \>= 100 ng/mL * AE with a CTC grade greater than or equal to 3 * New, treatment-emergent diagnosis of bladder fibrosis.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Single arm, open label, single dose, intravesical instillation of Chemophase (combination of rHuPH20 and mitomycin) for appropriate superficial bladder cancer patients within 6 hours of TURBT. |
| Cohort 1: MMC plus Chemophase 20,000 U | EXPERIMENTAL | Participants will receive 40 milligrams (mg) MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6. |
| Cohort 2: MMC plus Chemophase 60,000 U | EXPERIMENTAL | Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6. |
| Cohort 3: MMC plus Chemophase 200,000 U | EXPERIMENTAL | Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6. |
| Cohort 4: MMC plus Chemophase 400,000 U | EXPERIMENTAL | Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6. |
| Cohort 5: MMC plus Chemophase 800,000 U | EXPERIMENTAL | Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6. |
| Name | Type | Description |
|---|---|---|
| Chemophase | DRUG | 40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled |
| Mitomycin C | DRUG | intravesical administration |
Inclusion Criteria: * Patient with histologically confirmed or suspected (based on cystoscopy) initial presentation or recurrence of Stage Ta, T1, or Tis transitional cell bladder cancer of any histological grade requiring TURBT. * Patient believed to be a candidate for immediate post-operative che...
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Chemophase is an investigational small molecule being studied for the treatment of bladder cancer, including superficial bladder cancer. It is administered as an intravesical instillation, meaning it is delivered directly into the bladder. Chemophase is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Chemophase is being developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HALO. The company is conducting clinical trials to evaluate the safety and efficacy of Chemophase in patients with bladder cancer.
Chemophase is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving patients with bladder cancer. As an investigational drug, Chemophase has not been approved by the FDA or other regulatory agencies and remains in the early stages of clinical testing.
Chemophase has been studied in two completed Phase 1 clinical trials. The first trial, NCT00318643, evaluated Chemophase in combination with mitomycin in 27 participants with superficial bladder cancer. The second trial, NCT00782587, studied immediate post-operative intravesical instillation of Chemophase in 14 patients with superficial bladder cancer.
Chemophase is administered via intravesical instillation, a method where the drug is delivered directly into the bladder through a catheter. This route of administration is commonly used for treating bladder cancer to maximize drug exposure to the tumor while minimizing systemic side effects.