Clinical trial NCT06925581: A Trial of HRS-6768 in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. 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.
3. There must be at least one measurable lesion as the target lesion (according to the RECIST V1.1 criteria).
4. ECOG 0-1
5. The functions of major organs are in good condition.

Exclusion Criteria:

1. The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
2. 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.
3. 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.
4. 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).

Primary outcomes:
measure: Phase 1:Dose-limiting toxicity (DLTs)
timeFrame: From first dose of study drug through at least 6 weeks
measure: Phase 1: recommended Phase 2 dose (RP2D)
timeFrame: From first dose of study drug to end of phase 1 treatment (up to approximately 1 years)
measure: Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768
timeFrame: From first dose of study drug to end of treatment (up to approximately 2 years)
measure: Phase 2: Objective Response Rate (ORR)
timeFrame: From first dose of study drug to end of treatment (up to approximately 2 years)
Secondary outcomes:
measure: Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1/2: Cmax of HRS-6768
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1/2: Tmax of HRS-6768
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1/2: Area under the curve (AUC) of HRS-6768
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1/2: clearance (CL) of HRS-6768
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1: Objective Response Rate (ORR)
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 1 years)
measure: Phase 1/2: Duration of Response (DoR)
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1/2: Disease Control Rate (DCR)
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1/2: Progression-free survival (PFS)
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
measure: Phase 1/2: Overall Survival (OS)
timeFrame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: