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Monoclonal Antibodies
Vudalimab + Chemotherapy/Targeted Therapy for Prostate Cancer
Phase 2
Recruiting
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial will study the safety and effectiveness of XmAb20717 as a treatment for patients with metastatic prostate cancer who have been previously treated with other cancer therapies.
Who is the study for?
This trial is for adults with metastatic castration-resistant prostate cancer who've had at least two prior anticancer treatments. Participants must have a confirmed diagnosis, documented disease progression, and be on or willing to continue androgen suppression if not surgically castrated. They should have specific genetic profiles based on the cohort they fit into and must not be receiving other anticancer therapies.
What is being tested?
The study tests vudalimab (XmAb20717) alone or combined with chemotherapy or targeted therapy in patients with advanced prostate cancer. It aims to assess safety and effectiveness after previous treatments failed. The combinations include vudalimab with olaparib, cabazitaxel or docetaxel, carboplatin plus one of the taxanes, or as monotherapy.
What are the potential side effects?
Potential side effects may include immune-related reactions due to vudalimab's action on the immune system; these can affect various organs. Chemotherapy could cause fatigue, nausea, hair loss, blood cell count changes leading to increased infection risk, bruising or bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort E - No Targetable MutationsExperimental Treatment2 Interventions
XmAb20717 + carboplatin + cabazitaxel
Group II: Cohort D - MSI-H, MMRD or TMB-HExperimental Treatment1 Intervention
Group III: Cohort C - HRD/CDK12 PARP NaïveExperimental Treatment1 Intervention
XmAb20717 + olaparib
Group IV: Cohort B - HRD/CDK12 PARP - ProgressorsExperimental Treatment1 Intervention
XmAb20717 + carboplatin + cabazitaxel
Group V: Cohort A - AVPCaExperimental Treatment1 Intervention
XmAb20717 + carboplatin + cabazitaxel
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Who is running the clinical trial?
Xencor, Inc.Lead Sponsor
29 Previous Clinical Trials
2,363 Total Patients Enrolled
1 Trials studying Prostate Cancer
78 Patients Enrolled for Prostate Cancer
Jolene ShorrStudy DirectorXencor, Inc.
1 Previous Clinical Trials
168 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live-virus vaccine in the last 30 days.I have recovered from previous cancer treatment side effects to a mild level.I do not have HIV or hepatitis B/C, or it is under control.I am on hormone therapy to lower testosterone and willing to continue it.I am willing and able to follow the study's schedule.I have experienced severe side effects from previous immunotherapy.My prostate cancer diagnosis was confirmed through a tissue examination.I am fully active or restricted in physically strenuous activity but can do light work.I am currently on cancer treatment excluding hormone therapy.I have previously been treated with docetaxel.I haven't had cancer treatment in the last 2 weeks.My condition worsened despite previous treatments.I have previously been treated with specific immunotherapy.My prostate cancer is worsening despite treatment.My blood, liver, kidney, heart functions are normal and I don't have autoimmune diseases.I can provide samples of my cancer that has spread, or I agree to a biopsy.I have had a serious infection recently.I am 18 years old or older.My cancer has been genetically tested and falls into one of the specific groups.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B - HRD/CDK12 PARP - Progressors
- Group 2: Cohort D - MSI-H, MMRD or TMB-H
- Group 3: Cohort E - No Targetable Mutations
- Group 4: Cohort A - AVPCa
- Group 5: Cohort C - HRD/CDK12 PARP Naïve
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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