Phase I Study of HBT-708 for Patients With Advanced Solid Tumors

NCT ID: NCT06993870

Last Updated: 2025-07-11

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2027-06-28

Brief Summary

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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

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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.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

HBT-708

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

HBT-708

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

HBT-708

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

HBT-708

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

HBT-708

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

HBT-708

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

HBT-708

Intervention Type DRUG

bispecific antibody

Interventions

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HBT-708

bispecific antibody

Intervention Type DRUG

Other Intervention Names

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SSGJ-708

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Qi Li

Role: primary

13818207333

Other Identifiers

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HBT-708-101

Identifier Type: -

Identifier Source: org_study_id

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