Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IS-002 · 1 trial · 1 indication
Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels |
| Name | Type | Description |
|---|---|---|
| IS-002 | DRUG | Intravenous injection of IS-002 Investigational Drug |
Inclusion Criteria: * Subject is between the ages of 18 and 75. * Subject has a confirmed adenocarcinoma by histology of the prostate. * Subject has CAPRA \> 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases * Subject is scheduled to u...
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IS-002 is an investigational small molecule being studied for the treatment of prostate cancer. It is administered by injection to patients undergoing robotic prostatectomy. The drug is currently in Phase 1 clinical development and is not yet approved by the FDA.
IS-002 is being developed by Intuitive Surgical, Inc., a company traded on NASDAQ under the ticker ISRG. The company is conducting clinical research on this investigational small molecule for prostate cancer.
IS-002 is in Phase 1 clinical development. A Phase 1 study of IS-002 injection in patients undergoing robotic prostatectomy has been completed. The drug is investigational and has not received FDA approval.
IS-002 has one completed clinical trial, identified as NCT04574401, titled "A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy." This trial enrolled 24 male patients aged 18 years and older with prostate cancer in the United States.
IS-002 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for prostate cancer. The completed Phase 1 trial, NCT04574401, was an uncontrolled study that did not use randomization or blinding.