Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05553639
Other study ID # H-300-001
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date May 23, 2023
Est. completion date April 29, 2024

Study information

Verified date June 2024
Source Hookipa Biotech GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date April 29, 2024
Est. primary completion date April 29, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 - 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 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. Exclusion Criteria: 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. • 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). 5. 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. 6. 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. 7. Allogeneic tissue/solid organ transplant (e.g., allogeneic stem cell transplantation, xenogeneic transplant). 8. Active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or epidural or neurological metastasis. 9. Active infection requiring systemic therapy. 10. Positive COVID-19 test in 6 weeks prior to the enrollment. 11. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 12. Known history of Hepatitis B (HBV) (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C (HCV) infection (defined as HCV ribonucleic acid [RNA] is detected [qualitative]). 13. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia
United States City of Hope Duarte California
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Miami Cancer Institute Miami Florida
United States University of Miami - Sylvester Comprehensive Cancer Center Miami Florida
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 California Cancer Associates for Research & Excellence (cCARE) San Marcos California

Sponsors (1)

Lead Sponsor Collaborator
Hookipa Biotech GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I 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.
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
Primary 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 Phase I Number of participants with an antitumor response. According to the chosen RECIST and PCWG3 criteria including PSA decline. Approximately 2 years
Secondary Phase II The number of participants with preliminary anti-tumor activity. According to the chosen RECIST and PCWG3 criteria including PSA decline.
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.
Up to 24 months
See also
  Status Clinical Trial Phase
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Suspended NCT05361915 - Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05067140 - A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer Phase 1/Phase 2
Completed NCT03646162 - Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer Phase 2
Active, not recruiting NCT03413995 - Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations Phase 2
Not yet recruiting NCT06461689 - Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer
Recruiting NCT05078151 - Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer N/A
Recruiting NCT03507595 - Evaluation of the Metastasis and Recurrence of Prostate Cancer
Completed NCT03362359 - Ga-68-PSMA-11 in High-risk Prostate Cancer Phase 1/Phase 2
Recruiting NCT04116775 - Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer. Phase 2
Completed NCT03223727 - Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Recruiting NCT04983095 - Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer Phase 3
Recruiting NCT04086290 - National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients Phase 1/Phase 2
Recruiting NCT03129139 - A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04983628 - Molecular Profiling in Prostate Cancer
Active, not recruiting NCT03414437 - Post-eRADicAte - A Long Term Follow up of Subjects That Completed the eRADicAte Study (NCT 02097303)
Completed NCT02485691 - Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent Phase 4
Completed NCT03693742 - MSG Use With 18F-DCFPyL PET/CT Imaging N/A
Completed NCT01322490 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer Phase 3
Completed NCT03739684 - Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer Phase 3