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Recruiting NCT06925581

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

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-6768.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug HRS-6768
    HRS-6768

Primary outcome measures

  • Phase 1:Dose-limiting toxicity (DLTs) [Time frame: From first dose of study drug through at least 6 weeks]
  • 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)]
  • 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 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 outcome measures (10)
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Beijing Gaobo Hospital — Beijing
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06925581 · HRS-6768-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗