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CAR T-cell Therapy

Fixed SC for Prostate Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Harpoon Therapeutics

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 4 years

Awards & highlights

Study Summary

This trialstudies a new drug to treat advanced prostate cancer that doesn't respond to current treatments. It looks at safety, tolerability, and how the body processes the drug.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and Severity of Dose Limiting Toxicities (DLTs) Following Treatment With Escalating Doses of HPN424

Secondary outcome measures

Part 1 and 2: Adverse events (NCI CTCAE version 5.0)

Part 1 and 2: Effects of HPN424 on circulating lymphocytes and systemic soluble immune factors

Part 1 and 2: Incidence of anti-drug antibodies (ADA) against HPN424

+5 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Fixed SCExperimental Treatment1 Intervention

Fixed subcutaneous dose (120 ng/kg)

Group II: Fixed IVExperimental Treatment1 Intervention

HPN424 administered once weekly via IV infusion in doses ranging from 1.3 to 150 ng/kg

Group III: 2 Prime Step IV 450 ng/kg TargetExperimental Treatment1 Intervention

Step-dosing IV cohorts who received 2 Prime Doses followed by the Target Dose (100/300/450 ng/kg and 50/150/450 ng/kg)

Group IV: 2 Prime Step IV 300 ng/kg TargetExperimental Treatment1 Intervention

Step-dosing IV cohorts who received 2 Prime Doses followed by the Target Dose (50/150/300 ng/kg with prior chemotherapy and 50/150/300 ng/kg no prior chemotherapy)

Group V: 1 Prime Step IV 36 ng/kg TargetExperimental Treatment1 Intervention

Step-dosing IV cohort who received a single Prime Dose followed by the Target Dose (12/36 ng/kg)

Group VI: 1 Prime Step IV 225-300 ng/kg TargetExperimental Treatment1 Intervention

Step-dosing IV cohorts who received a single Prime Dose followed by the Target Dose (100/300 ng/kg and 75/225 ng/kg]

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Who is running the clinical trial?

Harpoon TherapeuticsLead Sponsor

3 Previous Clinical Trials

354 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has enrollment for this experiment opened to the public yet?

"As per the data shared on clinicaltrials.gov, this research has concluded its patient recruitment phase; it was initially posted in July 2018 and last amended in January 2023. However, 1238 other studies are still actively seeking volunteers at present."

Answered by AI

Are there a plethora of sites in the US administering this research?

"This research is taking place from a variety of locations around the United States, with some notable centres being University of Colorado Hospital in Aurora, Northwestern University in Chicago and the University of Chicago in Detroit. A total of 14 medical sites are involved overall."

Answered by AI

What are the expectations of this clinical trial in regard to results?

"This clinical trial's primary outcome is the overall response rate (ORR) as measured by PCWG3 criteria, which will be assessed over a period of two 21-day cycles. Secondary goals include evaluating preliminary anti-tumor activity through progression free survival (PFS), duration of response (DOR), and overall survival (OS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of HPN424 in Patients With Advanced Prostate Cancer

2018. "Study of HPN424 in Patients With Advanced Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03577028.