PDS01ADC with Docetaxel for Metastatic Prostate Cancer
This study is testing if combining the drugs PDS01ADC and docetaxel is safe and effective for men with prostate cancer that has spread to other parts of the body (metastatic). Some participants will also receive abiraterone. The study aims to see if this combination can help delay the time it takes for the cancer to worsen. Researchers will measure how well the treatment works and check for any side effects. You may be able to join if you are a man aged 18 or older with metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC). The study is looking for 86 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is planned to enroll 86 men.
- What's involved
- Participants will be screened with a medical history and physical exam. PDS01ADC is given as a shot every three weeks, and docetaxel is given through an IV every 21 days for up to 6 cycles or until the cancer worsens or side effects are too strong.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will evaluate how well the treatment works at 4-8 weeks and monitor safety for up to 6 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04633252
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~86 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PDS01ADCDocetaxelM7824PrednisoneADT
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine clinical efficacy in adults with prostate cancer treated with docetaxel in combination with the immunocytokine, PDS01ADC
Measured over 4-8 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Melissa L Abel, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
mCSPC participants:
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.
For Cohorts 1 and 2, Dose escalation and Safety Run-in, only: mCSPC may have high or low volume disease.
For Cohort 3, Dose Expansion: mCSPC participants must have high volume disease (as defined by visceral lesion or 4 or greater bone lesions, at least one of which is beyond the spine and pelvis).
mCRPC participants:
Must need ADT as part of their cancer therapy (unless previous orchiectomy)
Must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.
Must have not had progression while on docetaxel if given for mCSPC or within 3 months of completing docetaxel for mCSPC.
Progression defined as either rising PSA greater than 2.0 ng/ml or radiographic evidence of progression seen on CT scan or TC-99 bone scan.
Toxicities related to prior therapy, including surgery and/ or radiation, must have resolved to \<= grade 1.
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.
mCSPC participants:
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.
For Cohorts 1 and 2, Dose escalation and Safety Run-in, only: mCSPC may have high or low volume disease.
For Cohort 3, Dose Expansion: mCSPC participants must have high volume disease (as defined by visceral lesion or 4 or greater bone lesions, at least one of which is beyond the spine and pelvis).
mCRPC participants:
Must need ADT as part of their cancer therapy (unless previous orchiectomy)
Must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.
Must have not had progression while on docetaxel if given for mCSPC or within 3 months of completing docetaxel for mCSPC.
Progression defined as either rising PSA greater than 2.0 ng/ml or radiographic evidence of progression seen on CT scan or TC-99 bone scan.
Toxicities related to prior therapy, including surgery and/ or radiation, must have resolved to \<= grade 1.
Men age \>=18 years. Because no dosing or adverse event data are currently available on the use of PDS01ADC in combination with docetaxel in participants \<18 years of age, children are excluded from this study.
ECOG performance status 0-2.
Participants must have adequate organ and marrow function as defined below:
Absolute neutrophil count \>=1,500/mcL, without CSF support
Platelets \>=100,000/mcL
Hemoglobin \>9 g/dL
PT \<= 1.5 x ULN
aPTT \<= 1.5 x ULN
Total bilirubin \<= upper limit of normal (ULN), OR in participants with Gilbert's syndrome, a total bilirubin \<= 3.0
Serum albumin \>=2.8 g/dL
AST(SGOT)/ALT(SGPT) \<=1.5 X institutional upper limit of normal
Serum Creatinine OR Creatinine Clearance \<= 1.5 X institutional upper limits of normal OR \>=50 mL/min/1.73 m\^2 calculated by eGFR in the clinical lab for participants with serum creatinine levels \> 1.5 ULN
The effects of PDS01ADC in combination with docetaxel and abiraterone on the developing human fetus are unknown. For this reason and because docetaxel agents as well as other immuno-therapeutic agents used in this trial are known to be teratogenic, sexually active subjects and their female partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom)after enrollment on study , during the study treatment and for 4 months after the last dose of abiraterone, docetaxel or PDS01ADC, even if oral contraceptives are also used. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately and her partner should inform the study doctor immediately.
Ability of subject to understand and the willingness to sign a written informed consent document. Subject should be willing to travel to the NIH for follow-up visits.
Participants with prior immune checkpoint therapy are eligible to enroll upon PI discretion.
Exclusion
Immunocompromised status due to:
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.
Current use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto).
Concurrent use of CYP3A4 inducers or sensitive CYP2D6 substrates within 14 days or 5 half-lives, whichever is shorter.
Receipt of any investigational agent within 28 days (or 60 days for an antibody drug conjugates) before the first planned dose of study drugs.
Participants who are positive for Hepatitis B surface antigen and/or Anti-Hepatitis C antibody
Uncontrolled hypertension (SBP\>170/ DBP\>105)
Has received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.
Participants who have had prior docetaxel for mCRPC
mCSPC participants will be excluded if they did not start abiraterone within 6 weeks of ADT and/or had any docetaxel
Participants who have had progression within 3 months of completing docetaxel for mCSPC
History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC investigational agents used in the study
The subject has had evidence within 3 years of the start of study treatment of another active malignancy which required systemic treatment (except for nonmelanoma skin cancers or carcinoma in situ of the bladder).
The subject has active brain metastases or epidural disease.
Participants with greater than or equal to grade 2 peripheral neuropathy (defined by CTCAE 5.0) at baseline.
What this trial measures
- Determine clinical efficacy in adults with prostate cancer treated with docetaxel in combination with the immunocytokine, PDS01ADC4-8 weeks
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.DLT observation period (until the end of 6 weeks)
of the number and type of toxicities noted for participants who are evaluable for toxicity