NCT04116710

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

A Phase I, First-in-human, Dose-escalation Study to Evaluate the Safety and Immunologic Response After Administration of HS-130 in Combination With HS-110 (Viagenpumatucel-L) in Patients With Solid Tumors Refractory to Standard Care

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Heat Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, non-controlled, first-in-human Phase I study of HS-130 and HS-110 in patients with advanced solid tumors refractory to, or ineligible for, Standard of Care. Seven dose levels will be explored in escalating doses. For each dose level, patients will receive combination HS-130 and HS-110 via intradermal injections once every 14 days. The Dose Limiting Toxicity (DLT) window of observation will include the first 28 days of treatment. In the absence of progressive disease or unacceptable toxicity, patients will continue to receive combination treatment every two weeks until disease progression, death, patient's withdrawal of consent, Investigator decision to discontinue treatment, or intolerable toxicity, whichever occurs first.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	HS-110 (viagenpumatucel-L)	Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
BIOLOGICAL	HS-130	Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig

Timeline

• Start date: 2019-10-18
• Primary completion: 2021-08-12
• Completion: 2022-04-01
• First posted: 2019-10-07
• Last updated: 2023-08-23
• Results posted: 2023-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study