HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Unknown Primary
H-300-001 (primary)
NCI-2023-02949
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.
Objectives
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
- 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.
Treatment Sites in Georgia
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