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

NCT05553639 | Terminated Phase 1 FDA Drug

• 1 other identifier: H-300-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Prostate Cancer Metastatic

Keywords

Prostate; Prostate Cancer; Metastatic; Metastatic Cancer; Metastatic Prostate Cancer; Castration Resistant; Castration Resistant Prostate Cancer; mCRPC; CRPC; Vaccine; Viral Vector; Viral Therapy; Immunotherapy; Vaccine Therapy

Outcome Measures

Primary Outcomes (2)

• Phase I

  1. Frequency and type of DLT. A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 42 days of treatment. 2. Frequency and severity of adverse events (AEs). Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale, version 4.0.

  1. First 42 days of treatment, 2. Approximately 6 months

• Phase II

  The number of the participants with preliminary anti-tumor activity defined as: \- Objective Response Rate (ORR) per RECIST v1.1/iRECIST criteria

  Up to 2 years

Secondary Outcomes (2)

• Phase I

  Approximately 2 years

• Phase II

  Up to 24 months

Study Arms (1)

HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV)

EXPERIMENTAL

HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV)

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

Interventions

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

Alternating Therapy of HB-302 and HB-301. The first 5 doses will be administered every 3 weeks. The 6th dose will be administered 6 weeks after the 5th dose. Subsequent doses will be administered every 6 weeks.

HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All participants will be male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male participants ≥18 years of age on day of signing the informed consent form (ICF)
• Confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, and evidence of metastatic disease.
• Documented castration-resistant disease with serum level of testosterone \<50 ng/dL (1.7 nmol/L).
• 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.
• Must have ≥1 metastatic lesion that is present on baseline imaging
• Participants with liver metastasis are not eligible to enroll in this study
• Participants with only bone metastasis present at baseline are eligible to enroll in this study
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
• 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.
• Screening laboratory values must meet the criteria for adequate organ function that will be decided by the investigator.

You may not qualify if:

• 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.)
• Uncontrolled pain or uncontrolled symptoms related to worsening of underlying disease or symptomatic bone metastasis.
• 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.
• 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.
• Note: inhaled or topical steroids and adrenal replacement in doses equivalent to \>10 mg/day prednisone are permitted in the absence of active autoimmune disease.
• Any chronic immunosuppressive medication within 6 months prior to the first administration of study treatment (unless agreed otherwise between the Sponsor and the Investigator on a case-by-case basis).
• Has received a live or live-attenuated vaccine within 30 days of planned start of study therapy, unless agreed otherwise between the Sponsor and Investigator.
• Administration of non-live vaccines is allowed.
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device treatment, within 4 weeks prior to the first dose of treatment.
• Allogeneic tissue/solid organ transplant (e.g., allogeneic stem cell transplantation, xenogeneic transplant).
• Active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or epidural or neurological metastasis.
• Active infection requiring systemic therapy.
• Positive COVID-19 test in 6 weeks prior to the enrollment.

Sponsors & Collaborators

• Hookipa Biotech GmbH: lead

Study Sites (10)

City of Hope

Duarte, California, 91010, United States

Location

California Cancer Associates for Research & Excellence (cCARE)

San Marcos, California, 92069, United States

Location

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

The Cancer Institute of New Jersey CINJ Rutgers

New Brunswick, New Jersey, 08901, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Providence Cancer Institute

Portland, Oregon, 97213, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Head of Clinical Development

  Hookipa Biotech GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: September 23, 2022
• Study Start: May 23, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

US (10)