A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors

NCT04116710 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: HS130-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 open-label, single center, dose escalation study to determine a safe and effective maximum tolerated dose of HS-130 in combination with viagenpumatucel-L (HS-110) for adult subjects with advanced solid tumors who are refractory to Standard of Care.

Conditions

Advanced Solid Tumor

Keywords

Cancer; Immunotherapy; Vaccine; Intradermal; gp96; OX40; Combination Therapy; Co-stimulation; Heat Biologics

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity

  Number of Patients with Dose Limiting Toxicity (DLT)

  1 month

Study Arms (1)

Phase 1: HS-130 + HS-110 (viagenpumatucel-L)

EXPERIMENTAL

Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.

Biological: HS-110 (viagenpumatucel-L); Biological: HS-130

Interventions

HS-110 (viagenpumatucel-L) BIOLOGICAL

Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

Phase 1: HS-130 + HS-110 (viagenpumatucel-L)

HS-130 BIOLOGICAL

Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig

Phase 1: HS-130 + HS-110 (viagenpumatucel-L)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastatic or advanced, unresectable solid tumor who have progressed, or recurred following standard-of-care (SOC) therapies or are ineligible for safe and effective SOC therapies and for whom, in the opinion of the Investigator, experimental therapy with HS-130/HS-110 may be beneficial.
• Patients should have lesions that are safely accessible for biopsy and be willing to provide pre-treatment and on-treatment tissue biopsy. Fine-needle aspiration biopsy is not acceptable. Archival tumor tissue will be accepted in lieu of fresh biopsy at screening if sample was collected within 6-months from Cycle 1 Day 1, and the local pathologist confirms that an adequate amount of tissue/tumor cells exist to allow completion of all testing as outlined in the specimen collection manual.
• Age ≥ 18 years.
• Have an acceptable organ function:
• Albumin ≥ 2.5 g/dL.
• Total Bilirubin \< 3.0 × upper limit of normal (ULN) unless patient has Gilbert's syndrome.
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × ULN or ≤ 5 × ULN in the case of liver metastases.
• Calculated or measured creatinine clearance \> 35 mL/minute per the Cockcroft-Gault formula.
• Absolute neutrophil count ≥ 1,500/mm3.
• Hemoglobin ≥ 9 g/dL.
• Platelet count ≥ 100,000/mm3.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least three months.
• Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last treatment with HS-130 and/or HS-110.
• Patients must be willing and have the capacity to sign the informed consent form.

You may not qualify if:

• Have clinically significant cardiac disease, including:
• Onset of unstable angina within 6 months of signing the Informed Consent Form (ICF).
• Acute myocardial infarction within 6 months of the signing the ICF.
• Known congestive heart failure (Grade III or IV as classified by the New York Heart Association); and/ or a known decreased cardiac ejection fraction (LVEF) of \< 45%.
• Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management.
• Known or clinically suspected leptomeningeal disease. Stable, previously treated metastases in the brain or spinal cord, are allowed as long as these are considered stable (by CT or MRI), and not requiring systemic corticosteroids.
• History of ≥ grade 3 allergic reactions as well as known or suspected allergy or intolerance to any agent given in the course of this trial, live cell therapies, or live vaccines.
• History of suspected cytokine release syndrome (CRS).
• Known immunodeficiency disorders (testing not required).
• Ongoing or current autoimmune disease. Permanent but stable and manageable immune related adverse events (irAE) from prior therapies are permissible, if prednisone equivalent corticosteroid use does not exceed 10 mg/day.
• Any other condition requiring concurrent systemic immunosuppressive therapy (other than allowable exceptions which do not exceed 10mg/day of prednisone/corticosteroid use).
• Major surgery (requiring general anesthesia or inpatient hospitalization) within four weeks before first IMP administration.
• Any ongoing anticancer therapy including; small molecules, immunotherapy, chemotherapy, monoclonal antibodies or any other experimental drug. Prior therapy must be stopped within four weeks before first infusion in the study, or 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is shortest). Adjuvant anti-hormonal treatment(s) for previously treated breast cancer or prostate cancer are allowed. Bisphosphonates are allowed, Denosumab and other RANK ligand inhibitors are prohibited.
• Any other ongoing significant, uncontrolled medical condition as per Investigator discretion.
• Received a live vaccine within 30 days prior to first dose of study drug.

Sponsors & Collaborators

• Heat Biologics: lead

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Vice President, Clinical Development
• Organization: NightHawk Biosciences Inc.

barana@nighthawkbio.com

9197948950

Study Officials

• Rachel E. Sanborn, MD

  Providence Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: October 3, 2019
• First Posted: October 7, 2019
• Study Start: October 18, 2019
• Primary Completion: August 12, 2021
• Study Completion: April 1, 2022
• Last Updated: August 23, 2023
• Results First Posted: August 23, 2023

Record last verified: 2022-10

Locations

US (1)