Phase I Study of HBT-708 for Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HBT-708.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study to Evaluate the Safety, Tolerability, and Initial Efficacy of HBT-708 Monotherapy for Patients With Advanced Solid Tumors
Overview
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
- Drug HBT-708
bispecific antibody
Primary outcome measures
- Number of participants with any treatment-emergent adverse event (TEAE) and dose-limiting toxicities [Time frame: up to 24 months (every cycle visit, each cycle is 21 days)]
- Determine the maximum tolerated dose (MTD) and the maximum administration dose [Time frame: up to 24 months (every cycle visit, each cycle is 21 days)]
Secondary outcome measures (1)
- the plasma concentration of HBT-708 [Time frame: 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)]
Eligibility criteria
Inclusion criteria
- Male or female subjects, age 18 years or older.
- Histologically and/or cytologically documented advanced or measurable solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancey > = 3 months.
- Willingness to provide written informed consent for the study.
Exclusion criteria
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- 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).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai General Hospital — Shanghai
Identifiers
NCT: NCT06993870 · HBT-708-101