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

NCT06993870 | Recruiting Phase 1

• 1 other identifier: HBT-708-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

solid tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 24 months (every cycle visit, each cycle is 21 days)

• 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.

  up to 24 months (every cycle visit, each cycle is 21 days)

Secondary Outcomes (1)

• 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)

Study Arms (7)

Arm 1

EXPERIMENTAL

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.

Drug: HBT-708

Arm 2

EXPERIMENTAL

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.

Drug: HBT-708

Arm 3

EXPERIMENTAL

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.

Drug: HBT-708

Arm 4

EXPERIMENTAL

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.

Drug: HBT-708

Arm 5

EXPERIMENTAL

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.

Drug: HBT-708

Arm 6

EXPERIMENTAL

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.

Drug: HBT-708

Arm 7

EXPERIMENTAL

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.

Drug: HBT-708

Interventions

HBT-708 DRUG

bispecific antibody

Also known as: SSGJ-708

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6; Arm 7

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willingness to provide written informed consent for the study.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: June 16, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 28, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)