RecruitingPhase 1Phase 2NCT04633252

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

Sponsor

National Cancer Institute (NCI)

Enrollment

86 participants

Start Date

Feb 23, 2021

Study Type

INTERVENTIONAL

Conditions

Cancer of Prostate Prostate Neoplasms

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 110 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a new immunotherapy drug (M9241, which boosts the immune system's ability to fight cancer) with the chemotherapy drug docetaxel in men with metastatic prostate cancer. It covers two groups: those whose cancer is still responding to hormone therapy, and those whose cancer has become resistant to hormones. **You may be eligible if...** - You are an adult male with prostate cancer confirmed by biopsy - Your cancer has spread to at least one other area of the body (bone or other organ) - For hormone-sensitive cancer: you started hormone therapy (ADT) within the past 134 days - For hormone-resistant cancer: you have previously been treated with modern anti-androgen drugs (like enzalutamide or abiraterone) - Your blood counts, kidney, and liver function are within acceptable ranges **You may NOT be eligible if...** - You have active autoimmune disease or take immunosuppressant medications - You have had previous radiation to the chest or serious heart problems - You are on certain blood thinners or medications that interact with study drugs - Your cancer progressed while taking docetaxel Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPDS01ADC

PDS01ADC at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.

DRUGDocetaxel

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.

DRUGM7824

M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.

DRUGPrednisone

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.

DRUGADT

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.