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NCT Number: NCT06925581

A Trial of HRS-6768 in Patients With Advanced Solid Tumors

The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Gaobo Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to provide a written informed consent
  • subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods.
  • There must be at least one evaluable lesion .
  • ECOG 0-1
  • The functions of major organs are in good condition.

Exclusion criteria

  • The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
  • The patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (EBRT) involving more than 25% of the bone marrow, or has previously had EBRT directly applied to the kidneys, or has received any EBRT within 2 weeks before the first dose.
  • The patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose.
  • The patient has had a severe infection (CTCAE > Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. The patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).

Treatment and study plan

HRS-6768

Drug

HRS-6768

Primary outcomes

  1. Phase 1:Dose-limiting toxicity (DLTs)

    Time frame: From first dose of study drug through at least 6 weeks

    To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.

  2. Phase 1: recommended Phase 2 dose (RP2D)

    Time frame: From first dose of study drug to end of phase 1 treatment (up to approximately 1 years)

    To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.

  3. Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768

    Time frame: From first dose of study drug to end of treatment (up to approximately 2 years)

    Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768

  4. Phase 2: Progression-free survival (PFS)

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

Secondary outcomes

  1. Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    To measure the radiation dosimetry of HRS-6768

  2. Phase 1/2: Cmax of HRS-6768

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    To evaluate the PK of HRS-6768

  3. Phase 1/2: Tmax of HRS-6768

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    To evaluate the PK of HRS-6768

  4. Phase 1/2: Area under the curve (AUC) of HRS-6768

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    To evaluate the PK of HRS-6768

  5. Phase 1/2: clearance (CL) of HRS-6768

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    To evaluate the PK of HRS-6768

  6. Phase 1/2: Objective Response Rate (ORR)

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 1 years)

    Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator.

  7. Phase 1/2: Duration of Response (DoR)

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

  8. Phase 1/2: Disease Control Rate (DCR)

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR.

  9. Phase 1: Progression-free survival (PFS)

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    Progression-free survival (PFS) is defined as the time from the date of first dose to the date of first evidence of radiographic progression or death due to any cause, whichever occurred first.

  10. Phase 1/2: Overall Survival (OS)

    Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

    Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Zengquan Gu

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase I/II Clinical Trial to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-6768 in the Treatment of Patients With Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 13, 2025
Registry last updated
Dec 3, 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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