Experimental prostate cancer combo trial halted early
NCT ID NCT05733351
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested a new immunotherapy drug called vudalimab (XmAb20717) alongside standard treatments for men with metastatic castration-sensitive prostate cancer. The study aimed to check safety and early signs of effectiveness. However, the trial was terminated early after enrolling only 4 participants, so no conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vudalimab (XmAb20717) plus standard of care (abiraterone, enzalutamide, or docetaxel)
- What this could lead to
- If successful, this could point toward a new combination therapy that helps control metastatic prostate cancer for longer.
- What could go wrong
- This was a very early, small Phase 1 trial that was terminated early with only 4 participants. It is too early to know if the combination is safe or effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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4 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Jun 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>= 18 years * Histologically confirmed adenocarcinoma of the prostate with metastatic disease * Castration-sensitive status: either not have been treated with androgen deprivation therapy (ADT) (hormone therapy) or not on ADT at the time of progression * Participants can have received up to 3 months of ADT with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists or orchiectomy with or without concurrent first-generation antiandrogens prior to enrollment, with no radiographic evidence of disease progression or rising prostate-specific antigen (PSA) prior to enrollment * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Life expectancy \> 12 weeks as determined by the investigator * Hemoglobin \>= 9.0 g/dl (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of Cycle 1 Day 1 to meet entry criteria) * White blood cell (WBC) \>= 2000/uL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion) * Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion) * Platelets \>= 100,000/mcL (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) * Prothrombin time (PT)/ partial thromboplastin time (PTT) =\< 1.5 x upper limit of normal (ULN) (within 28 days of cycle 1 day 1) * Total bilirubin =\< 1.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 3 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1) * Serum creatinine =\< 2 mg/dL (or glomerular filtration rate \>= 40 mL/min) (within 28 days of cycle 1 day 1) * Willingness to provide pre- and post-treatment fresh tumor biopsies, if safe and medically feasible * Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of Xmab27017 * Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol specified laboratory tests, other study procedures, and study restrictions * Completion of all previous surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy for the treatment of cancer \>= 2 weeks before the start of study therapy. (No radiotherapy to Xmab27017 injection site within 4 weeks) * Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \> grade 1) * Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs * Prior treatment with any CTLA4, PD1, or PDL1, or directed immunotherapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to (investigational new drug \[IND\] agent\[s\]) or other agents used in study * Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), are clinically stable, and are without requirement of steroid treatment for at least 14 days prior to first dose of study treatment * Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs) * Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted.) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Receipt of an organ allograft * Known history of left ventricular ejection fraction =\< 40% * Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted. COVID-19 vaccines are permitted) * Known human immunodeficiency virus (HIV) positive subject with CD4+ T-cell (CD4+) counts \< 350 cells/uL, or an HIV viral load greater than 400 copies/mL, or a history of an AIDS (acquired immunodeficiency syndrome)-defining opportunistic infection within the past 12 months, or who has not been on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. (Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load.) * Known positive test for hepatitis C ribonucleic acid (RNA) (a subject who is hepatitis C virus \[HCV\] antibody positive but HCV RNA negative due to documented, curative prior antiviral treatment or natural resolution is eligible). * Known positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb; a subject whose HBsAg is negative and HBcAb is positive may be enrolled if a hepatitis B virus \[HBV\] deoxyribonucleic acid (DNA) test is negative, and the subject is retested for HBsAg and HBV DNA every 2 months)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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