At a glance
ClinicalIndex Comparison Record- ✓Documented histopathological confirmation of prostate cancer
- ✓Metastatic disease with at least one lesion on bone scan or measurable per RECIST 1.1
- ✓mCSPC: within 134 days of starting ADT
- ✓mCSPC Cohorts 1-2: high or low volume disease allowed
- ✕HIV positivity
- ✕Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, SLE, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Grave's disease
- ✕Other immunodeficiency diseases that could compromise participant
- ✕Serious intercurrent medical illness that would interfere with treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
In Brief
A Phase 1 clinical trial evaluating PDS01ADC, Docetaxel, and 3 other interventions for Cancer Of Prostate and Prostate Neoplasms. Currently recruiting, targeting 86 participants across 1 site.
Detailed Summary
Background: Metastatic castration sensitive and castration resistant prostate cancer (mCSPC and mCRPC) are prostate cancers that have spread to other parts of the body. Use of the drug docetaxel with androgen deprivation therapy can improve survival for men with mCSPC. Researchers want to see if combining this treatment with other drugs can help delay the time it takes for mCSPC and mCRPC to get worse. Objective: To learn if giving docetaxel with PDS01ADC is safe and effective for men with prostate cancer. Eligibility: Men age 18 and older with mCSPC or mCRPC. Design: Participants will be screened with a medical history and physical exam. Their diagnosis will be confirmed. Their symptoms and how well they do their normal activities will be reviewed. They will have blood and urine tests. Their heart will be evaluated. They will have imaging scans of the chest, abdomen, and pelvis. They will have bone scans with intravenous (IV) injections of Tc99 to check for tumor spread in the bones. Some screening tests will be repeated during the study. Participants may have tumor biopsies. Participants will get treatment in cycles. Each cycle will last 21 days. They will get docetaxel through IV infusion. They will get PDS01ADC as an injection under the skin. Participants with mCSPC will have up to 6 cycles. Those with mCRPC will be treated until they cannot tolerate the side effects or their disease gets worse. Participants will have a follow-up visit 30 days after treatment ends. Those with mCSPC will then have follow-up visits at the clinic every 3 months.
Study Details
Timeline
Arms & Interventions
Docetaxel plus PDS01ADC dose escalation with optional prednisone and ADT as part of SOC
Docetaxel plus PDS01ADC RP2D plus M7824 with optional prednisone and ADT as part of SOC
Docetaxel plus PDS01ADC RP2D with optional prednisone and ADT as part of SOC
Docetaxel plus PDS01ADC RP2D with optional prednisone and ADT as part of SOC
Interventions
PDS01ADC at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.
Docetaxel 75mg/m\^2 will be administered intravenously every 21 days (i.e., a 3-week cycle) for up to 6 cycles in mCSPC and until progression or unacceptable toxicity in mCRPC.
M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.
For mCSPC patients, prednisone is optional and if given, should be taken orally, at 5 mg once a day. For mCRPC patients, prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day as is the patient s preference.
For mCSPC patients: Androgen Deprivation Therapy (ADT) may include GnRH agonist or monthly degarelix converted to GnRH agonist after 3 months. For mCRPC patients: ADT will be continued as per standard of care.