A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04116710|
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Biological: HS-110 (viagenpumatucel-L) Biological: HS-130||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 18, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Phase 1: HS-130 + HS-110 (viagenpumatucel-L)
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)
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
- Frequency of TEAEs, SAEs, and DLTs [ Time Frame: Up to 18 months ]Treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs) will be assessed by CTCAE v5.0
- To determine maximum tolerated dose and optimal immunological dose [ Time Frame: Up to 18 months ]The recommended phase 2 dose will be defined as an optimal immunological dose consisting of MTD as well as changes in immune markers in response to treatment.
- Best Overall Response [ Time Frame: Up to 16 months ]Best Overall Response (BOR) as determined using RECIST v1.1.
- Overall Survival [ Time Frame: Up to 18 months ]Overall Survival (OS) will be calculated as the duration from the date of first dose until the date of death from any cause, or is censored at date last known alive.
- Progression-Free Survival [ Time Frame: Up to 18 months ]Progression-Free Survival (PFS) is defined as the duration from the date of first dose to the date of the first documented tumor progression (per RECIST v1.1) or death due to any cause.
- Immunological effect [ Time Frame: Up to 18 months ]Immunological effect will be assessed by evaluating proportions of natural killer (NK) and T cell subsets for levels of activation, memory and exhaustion using flow cytometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116710
|Contact: Tiffany Nunnemail@example.com|
|Contact: Karen Arringtonfirstname.lastname@example.org|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Katie Tripp 503-215-0449 Katie.Tripp@providence.org|
|Principal Investigator: Rachel Sanborn, MD|
|Principal Investigator:||Rachel E. Sanborn, MD||Providence Cancer Institute|