Prostate Cancer MetastaticPhase 1/2NCT05553639
HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 1/2 study testing HB-302/HB-301 Alternating 2-Vector Therapy in people with Prostate Cancer Metastatic, run by Hookipa Biotech GmbH at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- HB-302/HB-301 Alternating 2-Vector Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 10 sitesUnited States
- Study dates
- 23 May 2023to 29 Apr 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- 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]).
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University Hospital
Atlanta, Georgia, 30322
City of Hope
Duarte, California, 91010
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Miami Cancer Institute
Miami, Florida, 33176
The Cancer Institute of New Jersey CINJ Rutgers
New Brunswick, New Jersey, 08901
Columbia University Irving Medical Center
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Providence Cancer Institute
Portland, Oregon, 97213
California Cancer Associates for Research & Excellence (cCARE)
San Marcos, California, 92069
About this study
Official title: A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants With Metastatic Castration-Resistant Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- HB-302/HB-301 Alternating 2-Vector Therapy
- 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
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-302/HB-301 Alternating 2-Vector TherapyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV) | Experimental | HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV) Receives: Biological: HB-302/HB-301 Alternating 2-Vector Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 2 years
Secondary outcomes (2)
Phase I
Number of participants with an antitumor response. According to the chosen RECIST and PCWG3 criteria including PSA decline.
Measured: Approximately 2 years
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start23 May 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Why it stopped: Decision by the company to terminate the H-300-001 study early for non-safety related reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hookipa Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Clinical Development, Study director, Hookipa Biotech GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553639
- Sponsor's protocol ID
- H-300-001
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05553639
- Acronym / sponsor ID
- H-300-001
- Conditions
- Prostate Cancer Metastatic
- Keywords
- Prostate, Prostate Cancer, Metastatic, Metastatic Cancer, Metastatic Prostate Cancer, Castration Resistant, Castration Resistant Prostate Cancer, mCRPC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision by the company to terminate the H-300-001 study early for non-safety related reasons.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hookipa Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV) | Experimental | Biological: HB-302/HB-301 Alternating 2-Vector TherapyHB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
- Must have ≥1 metastatic lesion that is present on baseline imaging
Key exclusion criteria (18 listed)
- 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.
- Has received the following immunosuppressive or systemic replacement medication:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-302/HB-301 Alternating 2-Vector TherapyAlternating 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. | Biological | HB-302/HB-301 Alternating 2-Vector Therapy Intravenously (IV) |
Primary outcome
Phase I
Time frame: 1. First 42 days of treatment, 2. Approximately 6 months
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.
Phase II
Time frame: Up to 2 years
The number of the participants with preliminary anti-tumor activity defined as: - Objective Response Rate (ORR) per RECIST v1.1/iRECIST criteria
2 secondary outcomes
Phase I
Time frame: Approximately 2 years
Phase II
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: Decision by the company to terminate the H-300-001 study early for non-safety related reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Head of Clinical Development study director
Hookipa Biotech GmbH
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HB-302/HB-301 Alternating 2-Vector Therapy in people with Prostate Cancer Metastatic, run by Hookipa Biotech GmbH at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decision by the company to terminate the H-300-001 study early for non-safety related reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I (time frame: 1. First 42 days of treatment, 2. Approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.