Phase I Study of HBT-708 for Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
The purpose of this study will be to evaluate the safety, tolerability, and inital efficacy of HBT-708 in subjects with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
HBT-708
Drugbispecific antibody
Treatment groups
60 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Experimental treatment 1 intervention
Group D: Arm 4Experimental treatment 1 intervention
Group E: Arm 5Experimental treatment 1 intervention
Group F: Arm 6Experimental treatment 1 intervention
Group G: Arm 7Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with any treatment-emergent adverse event (TEAE) and dose-limiting toxicities
Adverse event were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after informed consent.
Time frame
up to 24 months (every cycle visit, each cycle is 21 days)2
Determine the maximum tolerated dose (MTD) and the maximum administration dose
Adverse events were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after a participant provided informed consent.
Time frame
up to 24 months (every cycle visit, each cycle is 21 days)Secondary outcomes
1
the plasma concentration of HBT-708
PK parameters will be calculated from the blood plasma concentrations of HBT-708 using standard noncompartmental PK methods.
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov