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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HBT-708

• Registration Number: NCT06993870
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Brief Summary

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Start: 2025-06-16
• Primary Completion: 2026-03-01
• Study Completion: 2027-06-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	HBT-708	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.
Arm 2	HBT-708	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.
Arm 3	HBT-708	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.
Arm 4	HBT-708	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.
Arm 5	HBT-708	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.
Arm 6	HBT-708	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.
Arm 7	HBT-708	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with any treatment-emergent adverse event (TEAE) and dose-limiting toxicities	up to 24 months (every cycle visit, each cycle is 21 days)	Adverse event were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after informed consent.
Determine the maximum tolerated dose (MTD) and the maximum administration dose	up to 24 months (every cycle visit, each cycle is 21 days)	Adverse events were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after a participant provided informed consent.

Secondary Outcome Measures

Name	Time	Method
the plasma concentration of HBT-708	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)	PK parameters will be calculated from the blood plasma concentrations of HBT-708 using standard noncompartmental PK methods.