Phase I Study of HBT-708 for Patients With Advanced Solid Tumors
NCT ID: NCT06993870
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-06-16
2027-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 1 of HBT-708 Q3W i.v.
HBT-708
bispecific antibody
Arm 2
Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 2 of HBT-708 Q3W i.v.
HBT-708
bispecific antibody
Arm 3
Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 3 of HBT-708 Q3W i.v.
HBT-708
bispecific antibody
Arm 4
Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 4 of HBT-708 Q3W i.v.
HBT-708
bispecific antibody
Arm 5
Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 5 of HBT-708 Q3W i.v.
HBT-708
bispecific antibody
Arm 6
Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 6 of HBT-708 Q3W i.v.
HBT-708
bispecific antibody
Arm 7
Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 7 of HBT-708 Q3W i.v.
HBT-708
bispecific antibody
Interventions
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HBT-708
bispecific antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shenyang Sunshine Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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HBT-708-101
Identifier Type: -
Identifier Source: org_study_id
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