Advanced Solid Tumors
Conditions
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.
Interventions
DRUGHRS-6768
HRS-6768
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 evaluable lesion . 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1:Dose-limiting toxicity (DLTs) | From first dose of study drug through at least 6 weeks | To evaluate the safety and tolerability of HRS-6768 and determine the RP2D. |
| Phase 1: recommended Phase 2 dose (RP2D) | 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. |
| Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768 | 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 |
| Phase 2: Progression-free survival (PFS) | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1/2: Cmax of HRS-6768 | 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 |
| Phase 1/2: Tmax of HRS-6768 | 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 |
| Phase 1/2: Duration of Response (DoR) | 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) | 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. |
| Phase 1: Progression-free survival (PFS) | 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. |
| Phase 1/2: Overall Survival (OS) | 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. |
| Phase 1/2: Disease Control Rate (DCR) | 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. |
| Phase 1/2: Area under the curve (AUC) of HRS-6768 | 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 |
| Phase 1/2: clearance (CL) of HRS-6768 | 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 |
| Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions | 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 |
Countries
China
Contacts
Primary ContactZengquan Gu
Outcome results
None listed