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HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT05553639•Hookipa Biotech GmbH

View on ClinicalTrials.gov

Summary

Detailed Description

This is a first-in-human Phase 1/2, multinational, multicenter, open-label study of HB-302/HB-301 alternating 2-vector therapy in participants with metastatic castration-resistant prostate cancer (mCRPC) comprising 2 phases: a Phase 1 Dose Escalation and recommended Phase 2 dose (RP2D) Confirmation, and a Phase 2 Dose Expansion. The Phase 1 Dose Escalation will evaluate HB-302/HB-301 alternating 2-vector therapy for safety and tolerability, preliminary efficacy and immunogenicity, and determination of a safe recommended Phase 2 dose (RP2D). A confirmatory cohort (or cohorts) will inform the determination of the RP2D. The Phase 2 Dose Expansion will assess HB-302/HB-301 alternating 2-vector therapy at the RP2D defined in the Phase 1 part of the study. Study drugs HB-301 and HB-302 are genetically-engineered replicating vectors based on the arenavirus lymphocytic choriomeningitis virus (LCMV) and arenavirus Pichinde virus (PICV), respectively. HB-301 and HB-302 express the same transgenes encoding 2 prostate cancer-associated antigens: prostatic acid phosphatase (PAP) and prostate specific antigen (PSA). HB-302/HB-301 Alternating 2-vector therapy will be administered intravenously every 3 weeks (Q3W) for the first 5 doses and every 6 weeks (Q6W) from the fifth dose and onward. HB-302 is to be administered first followed 3 or 6 weeks later by HB-301. In total, approximately 70 participants aged 18 years and older will be enrolled in this study to receive HB-302/HB-301 alternating 2-vector therapy. About 40 Investigators and study sites in the United States (US) and Europe are expected to participate in this study.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Male participants ≥18 years of age on day of signing the informed consent form (ICF)
•2. Confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, and evidence of metastatic disease.
•3. Documented castration-resistant disease with serum level of testosterone \<50 ng/dL (1.7 nmol/L).
•4. Have been treated with at least one second-generation androgen receptor signaling inhibitor (ARSI) (e.g., enzalutamide)
•* No prior chemotherapy regimens are permitted (docetaxel in the castration-sensitive setting is acceptable)
•* Participants must have had disease progression on SOC therapy assessed by the Investigator.
•* Antiandrogen/ARSI withdrawal must take place at least 2 weeks before enrollment unless agreed otherwise between the Sponsor and the Investigator. LHRH agonists or antagonists should be continued.
•5. Must have ≥1 metastatic lesion that is present on baseline imaging

Exclusion Criteria

•* Participants with only bone metastasis present at baseline are eligible to enroll in this study
•6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
•7. Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration.
•8. Screening laboratory values must meet the criteria for adequate organ function that will be decided by the investigator.
•1. Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive study treatment, or interfere with the interpretation of the study results. This includes clinically significant (i.e., active) cardiovascular disease, including cerebral vascular accident/stroke and myocardial infarction less than 6 months prior to enrollment, unstable angina, congestive heart failure (New York Heart Association Classification Class II), or serious uncontrolled cardiac arrhythmias (including prolonged corrected QT interval, uncontrolled atrial fibrillation, etc.)
•2. Uncontrolled pain or uncontrolled symptoms related to worsening of underlying disease or symptomatic bone metastasis.
•3. An active autoimmune disease that has required systemic treatment in past 2 years.
•• Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
•4. Has received the following immunosuppressive or systemic replacement medication:
•* Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses \>10 mg/day prednisone or equivalent), within 14 days of the first administration of study treatment.
+12 more criteria

Locations (10)

City of Hope

Duarte, California, United States

California Cancer Associates for Research & Excellence (cCARE)

San Marcos, California, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

The Cancer Institute of New Jersey CINJ Rutgers

New Brunswick, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Providence Cancer Institute

Portland, Oregon, United States

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Key Dates

Start Date

May 23, 2023

Primary Completion Date

April 29, 2024

Completion Date

April 29, 2024

Last Updated

June 12, 2024

Enrollment

ACTUAL participants

Conditions

Prostate Cancer Metastatic

Interventions

HB-302/HB-301 Alternating 2-Vector Therapy

BIOLOGICAL

PSMA PET for Surveillance After Focal Therapy

NCT07115914

Prostate Cancer (Adenocarcinoma)Prostate Cancer (Diagnosis)+1 more

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RECRUITINGNA

Exercise in Prostate Cancer

NCT06165302

Prostate Cancer MetastaticProstate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

PSMA PET for Surveillance After Focal Therapy

Exercise in Prostate Cancer

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