The Safety, Tolerability, and Initial Efficacy of HX009 in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT04097769|
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: HX009||Phase 1|
The study will follow a 3+3 dose-escalation scheme enrolling cohorts of at least 3 subjects sequentially at escalating doses. During study treatment, subjects will receive HX009 treatment via intravenous infusion once every 2 weeks. Dose escalation will continue until identification of an MTD or the maximum dose is reached. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment (Day 1) until 28 days later (Day 29).
The study is divided into a screening period (28 days before first dose), treatment period (up to 24 months), and survival follow-up period. Safety will be evaluated throughout the study up until 90 (±7) days after the last dose of study treatment. Blood samples will be collected at regular intervals for pharmacokinetics (PK) and immunogenicity evaluation. Tumor evaluation (assessed by the Investigator in accordance with Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1] and immune RECIST [iRECIST]) to assess efficacy will start from the first dose and occur every 8 weeks in the first 12 months and every 12 weeks in the second 12 months and during the survival follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||HX009|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, First-in-Human Study Evaluating the Safety, Tolerability, and Initial Efficacy of HX009 in Patients With Advanced Malignancies|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||June 12, 2021|
|Estimated Study Completion Date :||September 12, 2021|
Study treatment: HX009 administered every 2 weeks (14 [±1] days) via intravenous infusion.
During study treatment, subjects will receive HX009 treatment via IV infusion once every 2 weeks at doses of 0.1, 0.3, 1, 2, 3, 5, and 7.5 mg/kg.
Other Name: anti-PD-1/CD47 infusion protein
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: All AEs up to 90 days after the last dose of study drug ]An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
- Number of Participants With Dose-Limiting Toxicities (DLT) of HX009 [ Time Frame: At the end of Cycle2(each cycle is 14 days) ]Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs.
- Time for Cmax (Tmax) of HX009 [ Time Frame: Approximately 2 years ]Time to reach HX009 maximum observed serum concentration.
- Terminal Half-life （t½）of HX009 [ Time Frame: Approximately 2 years ]HX009 terminal half-life.
- Area Under the Serum Concentration-time Curve (AUC) [ Time Frame: Approximately 2 years ]HX009 area under the serum concentration-time curve .
- Number of Participants With Positive Anti-Drug Antibody (ADA) of HX009 [ Time Frame: Cycles 1, 2, 3, 4, 5, 6, 7, 9, 13, and 17, and then every 8 cycles, Day 1: within 60 minutes before the start of the infusion(each cycle is 14 days) ]ADA blood samples were assayed for anti-HX009 antibodies.
- Objective response rate(ORR) Per Investigator Assessment Using RECIST 1.1 [ Time Frame: Approximately 2 years ]The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.
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): NCT04097769
|Contact: Jingxuan Xi||+61 0431704011||Josie@hanxbio.com|
|Australia, New South Wales|
|St George Private Hospital||Recruiting|
|Kogarah, New South Wales, Australia, 2217|
|Contact: Paul de Souza|
|Principal Investigator:||Paul de Souza||St George Private Hospital|