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

Shenyang Sunshine Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: HBT-708

Study type: Interventional

Funder types: Industry

Identifiers

NCT06993870

HBT-708-101

Details and patient eligibility

About

The purpose of this study will be to evaluate the safety, tolerability, and inital efficacy of HBT-708 in subjects with advanced solid tumors.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 7 patient groups

Arm 1

Experimental group

Description:

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.

Treatment:

Drug: HBT-708

Arm 2

Experimental group

Description:

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.

Treatment:

Drug: HBT-708

Arm 3

Experimental group

Description:

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.

Treatment:

Drug: HBT-708

Arm 4

Experimental group

Description:

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.

Treatment:

Drug: HBT-708

Arm 5

Experimental group

Description:

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.

Treatment:

Drug: HBT-708

Arm 6

Experimental group

Description:

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.

Treatment:

Drug: HBT-708

Arm 7

Experimental group

Description:

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.

Treatment:

Drug: HBT-708