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NCT Number: NCT06993870

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HBT-708

Drug

bispecific antibody

Other names: SSGJ-708

Primary outcomes

  1. Number of participants with any treatment-emergent adverse event (TEAE) and dose-limiting toxicities

    Time frame: 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.

  2. Determine the maximum tolerated dose (MTD) and the maximum administration dose

    Time frame: 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 outcomes

  1. the plasma concentration of HBT-708

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety, Tolerability, and Initial Efficacy of HBT-708 Monotherapy for Patients With Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 29, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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