A Phase I/II Study of TheraT? Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers.
Primary Objective:
To determine the RP2D in terms of safety and tolerability for:
a. IV administration of HB-201 in patients with HPV 16+ confirmed HNSCC
b. IT administration of HB-201 in patients with HPV 16+ confirmed cancers
c. IV administration of HB-202 in patients with HPV 16+ confirmed HNSCC
d. IV administration of HB-202 in patients with HPV 16+ confirmed cancers
HB-202
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Missak Haigentz MD
- Principal Investigator
Inclusion Criteria
All Patients:
- Documentation of confirmed HPV 16+ cancer via genotype testing.
- ≥ 1 measurable lesion by imaging for tumor response following RECIST
- ECOG performance status of 0 to 1.
- Prior curative radiation therapy and prior focal palliative completed per
protocol-specified wash-out windows.
- Screening laboratory values must meet protocol-specified criteria.
- Able to provide tumor tissue following last treatment, unless otherwise agreed.
Treatment Group E or Group F:
- Documentation of confirmed head and neck squamous cell carcinoma.
- Eligible to receive pembrolizumab, per standard of care and product label.
- Group E: this group includes first line / 1L patients who have not yet received
treatment in the metastatic/recurrent setting.
- Group F: Tumor progression or recurrence on standard of care therapy, including ≥1
systemic therapy.
Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center
only):
- Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
- At least 1 non-irradiated measurable lesion documented through imaging.
Exclusion Criteria
All patients:
- Metastatic central nervous system disease, and/or carcinomatous meningitis.
- Any serious or uncontrolled medical disorder that, in the opinion of the Investigator,
may increase the risk associated with study participation / treatment administration.
- Concurrent malignancy that is clinically significant or requires active intervention,
unless protocol-defined criteria are met.
- Active, known or suspected, autoimmune or inflammatory disorders requiring
immunosuppressive therapy.
- Has a life expectancy of less than 3 months.
- Any toxicities attributed to systemic prior anticancer therapy o that have not
resolved to Grade 1 or baseline prior to the first administration of study drug,
unless protocol-defined criteria is met.
- Not meeting the protocol-specified washout periods for prohibited medications.
- Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational
product(s) or any of the excipients of the investigational product(s).
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody,
indicating acute or chronic infection.
- Known history of acquired immunodeficiency syndrome.
For patients in Groups E or F and certain backfill cohorts:
- History of severe hypersensitivity reaction to or other contraindication to receiving
pembrolizumab.
- History of/Presently having non-infectious pneumonitis requiring treatment.
- Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving
prior therapy with check point inhibitors.
Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center
only):
- Having splenic disorders or prior splenectomy, and can compromise protocol objectives
per Investigator and/or Sponsor.
- Meeting requirements of exclusion criteria for Treatment Group 3
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.