Advanced Solid Tumors
Conditions
Keywords
solid tumors
Brief summary
The purpose of this study will be to evaluate the safety, tolerability, and inital efficacy of HBT-708 in subjects with advanced solid tumors.
Detailed description
This study is a study of HBT-708 monotherapy in advanced solid tumors. This study includes dose-escalation and dose-expansion cohort, with the accelerated titration combined 3+3 dose escalation method. The administration frequencies of HBT-708 is Q3W i.v. All cohorts will assess the efficacy and safety of the preset several dose levels of HBT-708 in advanced solid tumors.
Interventions
DRUGHBT-708
bispecific antibody
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, age 18 years or older. 2. Histologically and/or cytologically documented advanced or measurable solid tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Life expectancey \> = 3 months. 5. Willingness to provide written informed consent for the study.
Exclusion criteria
1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Subjects must have recovered (≤ Grade 1 or pretherapy baseline) from AEs due to previously administered therapies. (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0). 3. Inadequate organ or bone marrow function. 4. Pregnant or breast-feeding woman. 5. Known allergies, hypersensitivity, or intolerance to HBT-708 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with any treatment-emergent adverse event (TEAE) and dose-limiting toxicities | up to 24 months (every cycle visit, each cycle is 21 days) | Adverse event were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after informed consent. |
| Determine the maximum tolerated dose (MTD) and the maximum administration dose | up to 24 months (every cycle visit, each cycle is 21 days) | Adverse events were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after a participant provided informed consent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the plasma concentration of HBT-708 | Cycle1Day1, Cycle1Day2, Cycle1Day4, Cycle1Day8, Cycle1Day15; Cycle2 Day1; Cycle3 Day1, Cycle3Day2, Cycle3Day4, Cycle3Day8, Cycle3Day15; then Day 1 of every 2 cycles ( each cycle is 21 days) | PK parameters will be calculated from the blood plasma concentrations of HBT-708 using standard noncompartmental PK methods. |
Countries
China
Outcome results
None listed