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Prostate CancerPhase 1/2NCT06085729

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

A Phase 1/2 study testing ADI-PEG 20, Cabazitaxel and Carboplatin in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
ADI-PEG 20, Cabazitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
29 Feb 2024to 31 Dec 2027
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completion of informed consent prior to any study specific procedures.
  • Patients must agree to tissue collection for correlative studies at the specified timepoints.
  • Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291.
  • Male aged 18 years and above.
  • Histologically or cytologically confirmed prostate carcinoma.
  • Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans).
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  • Patients must meet at least one of the following AVPC criteria:
  • Histologically proven small cell (neuroendocrine) prostate carcinoma ii. Exclusive visceral metastases. iii. Predominantly lytic bone metastases identified by plain x-ray or CT scan. iv. Bulky (≥5cm in longest dimension) lymphadenopathy or high-grade tumor mass in prostate/pelvis. v. Low PSA (≤ 10ng/mL) at initial presentation (prior to androgen ablation or at symptomatic progression in the castrate-setting) plus high volume (≥ 20) bone metastases. vi. Elevated serum LDH (≥2 x ULN) or elevated serum CEA (≥2 x ULN) in the absence of other etiologies. vii. Short interval (≤180 days) to castrate-resistant progression following initiation of hormonal therapy. viii. Known loss or mutation (by CLIA certified molecular testing, IHC and/or DNA sequencing) in at least 2 of Tp53, RB1 and PTEN defined as:
  • AVPC determination by immunohistochemistry. Tumor samples are considered negative (and thus abnormal) for RB1 and PTEN if their labeling index is ≤ 10% and positive (and thus aberrant) for Tp53 if their labeling index is ≥ 10%, where the labeling index is defined as the percentage of positive cells, and calculated as the number of positively stained epithelial cells divided by the total number of epithelial cells, at X200 magnification.
  • AVPC determination by DNA sequencing. The TP53, RB1 and PTEN genes will be considered aberrant if they contain exonic nonsynonymous missense or stop-gain mutations, frameshift or non-frameshift indels (insertions or deletions), and/or copy number losses.
  • Patients who have castration-resistant disease progression per RECIST in the absence of PSA values rising to ≥ 1.0ng/mL as per PCGW3 PSA progression criteria
  • Patients must have documented evidence of progressive disease as defined by any of the following:
  • PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least ≥ 1.0 ng/mL; II. New or increasing non-bone disease (RECIST); III. Positive bone scan with 2 or more new lesions (PCWG3); IV. Increasing symptoms unequivocally attributed to disease progression as judged by the treating physician and the PI; V. Biopsy proven new transformation to small cell carcinoma in a patient previously diagnosed with an adenocarcinoma of the prostate.
  • Surgically or ongoing medically castrated, with baseline testosterone levels of ≤ 50 ng/dL (≤2.0 nM).
  • Exception: Patients with de novo primary small cell carcinoma of the prostate may begin chemotherapy on study once treatment with an LHRH agonist or antagonist has been initiated, even if testosterone levels have not reached ≤ 50ng/dL.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
  • Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below:
  • Hemoglobin ≥ 9.0 g/dL (unless deemed by the treating physician to be due to bone marrow infiltration by tumor, in which case hemoglobin ≥8gdL is allowed). Patient may have blood transfusions prior to study enrollment. II. Absolute neutrophil count (ANC) ≥1.5 x 109/L (unless deemed by the treating physician to be due to bone marrow infiltration by tumor, in which case ANC ≥1,000/mm3 is allowed) III. White blood cells (WBC) ≥3x109/L (unless deemed by the treating physician to be due to bone marrow infiltration by tumor, in which case WBC ≥2x109/L is allowed) IV. Platelet count ≥ 100 x 109/L (unless deemed by the treating physician to be due to bone marrow infiltration by tumor, in which case platelet ≥75,000/ mm3 is allowed) V. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). VI. AST (SGOT) and ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (unless liver metastases are present, in which case it must be ≤ 5x ULN) VII. Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL/min.
  • Patients who have partners of childbearing potential (e.g., female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use a method of birth control in addition to adequate barrier protection as determined to be acceptable by the investigator during the study and for 3 months after last dose of ADI-PEG 20 administration. In addition, men should not donate sperm during this period.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Any prior treatment for CRPC with carboplatin, cisplatin or cabazitaxel.
  • Patients who have received more than one line of chemotherapy for prostate cancer. Any number of prior hormonal or targeted therapies are allowed.
  • Patients who have not recovered from adverse events secondary to systemic therapy (except for LHRH agonist or antagonist treatment for prostate cancer, and bisphosphonates or RANK ligand inhibitors for bone strengthening), major surgery or radiotherapy for the treatment of prostate cancer to a grade </= 2.
  • Any unresolved toxicity (CTCAE Grade ≥2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
  • Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the PI; the PI will serve as the final arbiter regarding eligibility).
  • Active or symptomatic viral hepatitis or chronic liver disease.
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  • A history of extensive bilateral lung disease of non-malignant etiology.
  • A malignancy [other than the one treated in this study] which has a '≥ 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix or Ta urothelial carcinomas).
  • Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples: include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, superior vena cava syndrome, extensive bilateral lung disease on HRCT scan, uncontrolled seizures, history of allogeneic organ transplant, history of primary immunodeficiency or any psychiatric disorder that prohibits obtaining informed consent.
  • Patients with symptomatic uncontrolled brain metastases or spinal cord compressions. A scan to confirm the absence of brain metastases is not required.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, pegylated compounds, or other agents used in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ana Aparicio, MD contact

(713) 563-6969

aaparicio@mdanderson.org

United States1 site, 1 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Ana Aparicio, MD, 713-563-6969, aaparicio@mdanderson.org

    Ana Aparicio, MD

    Recruiting

Other trials in United States

About this study

To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.

Read the detailed description

Primary Objective:

To select an optimal dose of ADI-PEG 20 to combine with carboplatin+cabazitaxel

Secondary Objectives:

To determine the effects of ADI-PEG 20+carboplatin+cabazitaxel on

  1. Serum levels of arginine, citrulline and circulating anti-ADI-PEG 20 antibodies
  2. Intratumoral levels of arginine by ion chromatography/mass spectrometry
  3. Expression of ASS1 by immunohistochemistry
  4. Expression of genes involved in arginine metabolism and downstream pathways
  5. Immune checkpoint expression and immune-cell populations in the AVPC tumor microenvironment
  6. Safety and tolerability
  7. Overall response
  8. Progression-free survival
  9. Overall survival
Conditions
Prostate Cancer
Being tested
ADI-PEG 20, Cabazitaxel, Carboplatin
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADI-PEG 20Drug

    Given by Injection

  • CabazitaxelDrug

    Also called Jevtana®

    Given by IV (vein)

  • CarboplatinDrug

    Also called Paraplatin®

    Given by IV (vein)

Study groups in NCT06085729
Study groupRoleWhat they receive
Dose Escalation and Monotherapy MaintenanceExperimentalParticipants will be assigned to a study group and dose level of ADI-PEG20 based on when participant join this study. Up to 2 dose levels of ADI-PEG20 may be tested. Up to 15 participants will be enrolled per dose level.
Receives: Drug: ADI-PEG 20; Drug: Cabazitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start29 Feb 2024
  3. Primary completion2 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06085729
Sponsor's protocol ID
2023-0467
Other IDs
NCI-2023-08684
Status last verified
Sep 2026
First submitted
10 Oct 2023
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ADI-PEG 20, Cabazitaxel and Carboplatin in people with Prostate Cancer, run by M.D. Anderson Cancer Center 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 20 inclusion and 13 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 18 Sep 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 Ana Aparicio, MD ((713) 563-6969, aaparicio@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06085729.

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 18 Sep 2026.

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