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.
Participants must have documented histopathological confirmation of prostate cancer. If no pathologic specimen is available, participants may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
Participants must have metastatic disease, defined as at least one lesion on TC99 bone scan or at least one lesion that is measurable per, per RECIST 1.1.
Participants must be within 134 days of starting ADT.
If participants are on ADT and responding, this may impact the findings on scans. Pre- treatment scans could be used to confirm that participants have metastatic high-volume disease in such cases.
Human immunodeficiency virus (HIV) positivity
Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
Other immunodeficiency diseases that in the opinion of the investigator could compromise the participant or limit treatment efficacy
Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with participant s ability to carry out the treatment program.
Sequential
PDS01ADC
DrugPDS01ADC at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.
Docetaxel
DrugDocetaxel 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
DrugM7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.
Prednisone
DrugFor 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.
ADT
DrugFor 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.
Determine clinical efficacy in adults with prostate cancer treated with docetaxel in combination with the immunocytokine, PDS01ADC
For castration sensitive: Increase in the proportion of participants who have less than 0.2 ng/ml of PSA. For castration resistant: Increase in median progression free survival
To evaluate safety and tolerability of docetaxel in combination with PDS01ADC in patients who have metastatic prostate cancer.
of the number and type of toxicities noted for participants who are evaluable for toxicity
Evaluate radiographic response rates
Tumor progression on scans
Evaluate percentage of patients with a 50% PSA decline from baseline
PSA levels
Evaluate radiographic and biochemical time to progression for mCSPC patients
PSA levels and tumor progression on scans
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