Cancer Of ProstatePhase 1/2NCT04633252
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
A Phase 1/2 study testing PDS01ADC, Docetaxel and M7824 in people with Cancer Of Prostate and Prostate Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years, men only
- Conditions the study is for
- Cancer Of Prostate, Prostate Neoplasms
- What is being tested?
- PDS01ADC, Docetaxel and M7824
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 ofINCLUSION CRITERIA:
- 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
- -- Hepatic function based on Child-Pugh Class: Participants with hepatic impairment must have Child-Pugh Class A or better
- 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
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.
Read more
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.
Read the detailed description
Background:
- A phase III trial demonstrated that combining docetaxel and androgen deprivation therapy (ADT) significantly improved survival (57.6 vs 44.0 months (hazard ratio HR=0.56, (0.44- 0.70), p <0.0001) for men with metastatic castration sensitive prostate cancer (mCSPC). The greatest benefit was seen in men with high volume disease (visceral disease or 4+ bone lesions with at least one beyond the pelvis and spine.)
- Docetaxel has limited efficacy in metastatic castration resistant prostate cancer (mCRPC) patients who have already progressed on anti-androgen therapy (abiraterone or enzalutamide).
- Intensification of treatment in de novo mCSPC patients by adding abiraterone to docetaxel and ADT has been shown in a phase III trial to significantly improve OS (0.82, (0.69 - 0.98) p=0 (Summation)030) and rPFS (HR=0.54,(0.41-0.71) p <0.0001)
- Clinical data have indicated that PSA <=0.20 ng/ml eight months after starting androgen deprivation therapy (ADT) is prognostic for overall survival based on data from the phase III trial.
- Preclinical data demonstrates that docetaxel increases uptake of PDS01ADC, an IL-12 immunocytokine that targets necrosis.
- Additional preclinical data demonstrates the potential anti-tumor synergy of PDS01ADC when combined with docetaxel.
Objectives:
Phase I:
To evaluate safety and tolerability of docetaxel in combination with PDS01ADC in participants who have metastatic prostate cancer.
Phase II:
-Determine clinical efficacy in adults with prostate cancer treated when standard of care is combined with PDS01ADC. For mCSPC the standard of care is docetaxel + abiraterone. For mCRPC the standard of care is docetaxel.
- For mCSPC participants: Clinical efficacy will be measured by prostate specific antigen (PSA <0.2 ng/ml) eight months after start of androgen deprivation therapy (ADT).
- For mCRPC participants: Clinical efficacy will be measured by an increase in their median progression free survival (PFS).
Eligibility:
- Men age >=18 years
- 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
- mCSPC participants must be within 134 days of starting ADT.
- mCRPC participants must have been previously treated with ADT.
Design:
- Open-label, single-center, non-randomized Phase I/II study
- To ensure safety of the combination before using in larger numbers of mCSPC and mCRPC participants, PDS01ADC will be escalated from a starting dose of 12 mcg/kg and a second dose level of 16.8 mcg/kg along with docetaxel. mCSPC participants will receive a maximum of 6 cycles. mCRPC participants will continue until progression or unacceptable toxicity.
- The remaining participants will be enrolled onto the trial in the following expansion cohorts, each of which will receive the determined safe dose of PDS01ADC. ADT will be maintained/given per standard of care throughout the study.
- mCSPC participants: Once ADT established, simultaneous docetaxel 75 mg/m^2 (given every 3 weeks x 6 cycles starting at Cycle 1), with PDS01ADC at the RP2D, given every 3 weeks from cycle 2 through cycle 6). Abiraterone will be given in addition to docetaxel from the start of cycle 1 at a dose of 1000mg by mouth once daily. Prednisone will be given orally at 5 mg twice a day and will not be optional.
- The first 6 participants in the mCSPC arm including abiraterone will be evaluated as a safety lead-in of PDS01ADC at 12 mcg/kg. If there are 2 or more DLTs within these initial 6, then the doses will be de-escalated and 6 additional participants will be evaluated at this lower dose of PDS01ADC at 8 mcg/kg.
- mCRPC participants: docetaxel 75 mg/m^2 (given every 3 weeks starting at Cycle 1) with PDS01ADC at the RP2D, given every 3 weeks from cycle 2 onwards until disease progression or unacceptable toxicity. Prednisone will be given 5 mg twice a day for each dose or 10 mg once a day.
- It is anticipated that approximately 4 years may be required for accrual of up to 80 participants.
- Conditions
- Cancer Of Prostate, Prostate Neoplasms
- Being tested
- PDS01ADC, Docetaxel, M7824, Prednisone, ADT
- Keywords
- Chemoimmunotherapy, NHS IL-12, Check point inhibitor, Combination Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDS01ADCDrug
PDS01ADC at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.
DocetaxelDrug
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.
M7824Drug
M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.
PrednisoneDrug
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.
ADTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1/Dose Escalation | Experimental | Docetaxel plus PDS01ADC dose escalation with optional prednisone and ADT as part of SOC Receives: Drug: PDS01ADC; Drug: Docetaxel; Drug: Prednisone; Drug: ADT |
| 2/Safety Run-in (no longer applies; removed before enrollment) | Experimental | Docetaxel plus PDS01ADC RP2D plus M7824 with optional prednisone and ADT as part of SOC Receives: Drug: PDS01ADC; Drug: Docetaxel; Drug: M7824; Drug: Prednisone; Drug: ADT |
| 3/mCSPC: Dose Expansion | Experimental | Docetaxel plus PDS01ADC RP2D with optional prednisone and ADT as part of SOC Receives: Drug: PDS01ADC; Drug: Docetaxel; Drug: Prednisone; Drug: ADT |
| 4/mCRPC: Dose Expansion | Experimental | Docetaxel plus PDS01ADC RP2D with optional prednisone and ADT as part of SOC Receives: Drug: PDS01ADC; Drug: Docetaxel; Drug: Prednisone; Drug: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-8 weeks
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
Measured: DLT observation period (until the end of 6 weeks)
Secondary outcomes (3)
Evaluate radiographic response rates
Tumor progression on scans
Measured: 4-8 weeks
Evaluate percentage of patients with a 50% PSA decline from baseline
PSA levels
Measured: 4-8 weeks
Evaluate radiographic and biochemical time to progression for mCSPC patients
PSA levels and tumor progression on scans
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start23 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Of ProstateStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Melissa L Abel, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633252
- Sponsor's protocol ID
- 210001
- Other IDs
- 21-C-0001
- Status last verified
- 13 Oct 2026
- First submitted
- 17 Nov 2020
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04633252
- Acronym / sponsor ID
- 210001
- Conditions
- Cancer Of Prostate, Prostate Neoplasms
- Keywords
- Chemoimmunotherapy, NHS IL-12, Check point inhibitor, Combination Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- A phase III trial demonstrated that combining docetaxel and androgen deprivation therapy (ADT) significantly improved survival (57.6 vs 44.0 months (hazard ratio HR=0.56, (0.44- 0.70), p <0.0001) for men with metastatic castration sensitive prostate cancer (mCSPC). The greatest benefit was seen in men with high volume disease (visceral disease or 4+ bone lesions with at least one beyond the pelvis and spine.)
- Docetaxel has limited efficacy in metastatic castration resistant prostate cancer (mCRPC) patients who have already progressed on anti-androgen therapy (abiraterone or enzalutamide).
- Intensification of treatment in de novo mCSPC patients by adding abiraterone to docetaxel and ADT has been shown in a phase III trial to significantly improve OS (0.82, (0.69 - 0.98) p=0 (Summation)030) and rPFS (HR=0.54,(0.41-0.71) p <0.0001)
- Clinical data have indicated that PSA <=0.20 ng/ml eight months after starting androgen deprivation therapy (ADT) is prognostic for overall survival based on data from the phase III trial.
- Preclinical data demonstrates that docetaxel increases uptake of PDS01ADC, an IL-12 immunocytokine that targets necrosis.
- Additional preclinical data demonstrates the potential anti-tumor synergy of PDS01ADC when combined with docetaxel.
Objectives:
Phase I:
To evaluate safety and tolerability of docetaxel in combination with PDS01ADC in participants who have metastatic prostate cancer.
Phase II:
-Determine clinical efficacy in adults with prostate cancer treated when standard of care is combined with PDS01ADC. For mCSPC the standard of care is docetaxel + abiraterone. For mCRPC the standard of care is docetaxel.
- For mCSPC participants: Clinical efficacy will be measured by prostate specific antigen (PSA <0.2 ng/ml) eight months after start of androgen deprivation therapy (ADT).
- For mCRPC participants: Clinical efficacy will be measured by an increase in their median progression free survival (PFS).
Eligibility:
- Men age >=18 years
- 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
- mCSPC participants must be within 134 days of starting ADT.
- mCRPC participants must have been previously treated with ADT.
Design:
- Open-label, single-center, non-randomized Phase I/II study
- To ensure safety of the combination before using in larger numbers of mCSPC and mCRPC participants, PDS01ADC will be escalated from a starting dose of 12 mcg/kg and a second dose level of 16.8 mcg/kg along with docetaxel. mCSPC participants will receive a maximum of 6 cycles. mCRPC participants will continue until progression or unacceptable toxicity.
- The remaining participants will be enrolled onto the trial in the following expansion cohorts, each of which will receive the determined safe dose of PDS01ADC. ADT will be maintained/given per standard of care throughout the study.
- mCSPC participants: Once ADT established, simultaneous docetaxel 75 mg/m^2 (given every 3 weeks x 6 cycles starting at Cycle 1), with PDS01ADC at the RP2D, given every 3 weeks from cycle 2 through cycle 6). Abiraterone will be given in addition to docetaxel from the start of cycle 1 at a dose of 1000mg by mouth once daily. Prednisone will be given orally at 5 mg twice a day and will not be optional.
- The first 6 participants in the mCSPC arm including abiraterone will be evaluated as a safety lead-in of PDS01ADC at 12 mcg/kg. If there are 2 or more DLTs within these initial 6, then the doses will be de-escalated and 6 additional participants will be evaluated at this lower dose of PDS01ADC at 8 mcg/kg.
- mCRPC participants: docetaxel 75 mg/m^2 (given every 3 weeks starting at Cycle 1) with PDS01ADC at the RP2D, given every 3 weeks from cycle 2 onwards until disease progression or unacceptable toxicity. Prednisone will be given 5 mg twice a day for each dose or 10 mg once a day.
- It is anticipated that approximately 4 years may be required for accrual of up to 80 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1/Dose Escalation | Experimental | Drug: PDS01ADC, Drug: Docetaxel, Drug: Prednisone, Drug: ADTDocetaxel plus PDS01ADC dose escalation with optional prednisone and ADT as part of SOC |
| 2/Safety Run-in (no longer applies; removed before enrollment) | Experimental | Drug: PDS01ADC, Drug: Docetaxel, Drug: M7824, Drug: Prednisone, Drug: ADTDocetaxel plus PDS01ADC RP2D plus M7824 with optional prednisone and ADT as part of SOC |
| 3/mCSPC: Dose Expansion | Experimental | Drug: PDS01ADC, Drug: Docetaxel, Drug: Prednisone, Drug: ADTDocetaxel plus PDS01ADC RP2D with optional prednisone and ADT as part of SOC |
| 4/mCRPC: Dose Expansion | Experimental | Drug: PDS01ADC, Drug: Docetaxel, Drug: Prednisone, Drug: ADTDocetaxel plus PDS01ADC RP2D with optional prednisone and ADT as part of SOC |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- 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.
Key exclusion criteria (18 listed)
- Immunocompromised status due to:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDS01ADCPDS01ADC at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks. | Drug | 1/Dose Escalation, 2/Safety Run-in (no longer applies; removed before enrollment), 3/mCSPC: Dose Expansion, 4/mCRPC: Dose Expansion |
| DocetaxelDocetaxel 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. | Drug | 1/Dose Escalation, 2/Safety Run-in (no longer applies; removed before enrollment), 3/mCSPC: Dose Expansion, 4/mCRPC: Dose Expansion |
| M7824M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks. | Drug | 2/Safety Run-in (no longer applies; removed before enrollment) |
| PrednisoneFor 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. | Drug | 1/Dose Escalation, 2/Safety Run-in (no longer applies; removed before enrollment), 3/mCSPC: Dose Expansion, 4/mCRPC: Dose Expansion |
| ADTFor 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. | Drug | 1/Dose Escalation, 2/Safety Run-in (no longer applies; removed before enrollment), 3/mCSPC: Dose Expansion, 4/mCRPC: Dose Expansion |
Primary outcome
Determine clinical efficacy in adults with prostate cancer treated with docetaxel in combination with the immunocytokine, PDS01ADC
Time frame: 4-8 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.
Time frame: DLT observation period (until the end of 6 weeks)
of the number and type of toxicities noted for participants who are evaluable for toxicity
3 secondary outcomes
Evaluate radiographic response rates
Time frame: 4-8 weeks
Evaluate percentage of patients with a 50% PSA decline from baseline
Time frame: 4-8 weeks
Evaluate radiographic and biochemical time to progression for mCSPC patients
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa L Abel, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PDS01ADC, Docetaxel and M7824 in people with Cancer Of Prostate and Prostate Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy R Hankin, P.A.-C ((240) 858-3149, amy.hankin@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine clinical efficacy in adults with prostate cancer treated with docetaxel in combination with the immunocytokine, PDS01ADC (time frame: 4-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.