Advanced Solid Tumors
Conditions
Brief summary
This study is designed to determine if treatment with HRS-1167 alone is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Interventions
DRUGHRS-1167
Participants will receive HRS-1167.
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18； 2. ECOG performance status 0-1; 3. Life expectancy is not less than 12 weeks; 4. Dose escalation and PK expansion part: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists； 5. Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation； 6. At least one target lesion (except maintenance therapy); 7. Adequate organ and marrow function as defined by the protocol.
Exclusion criteria
1. Surgery or chemotherapy within 4 weeks of the first dose of study treatment； 2. Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption； 3. Active HBV/HCV/HIV infection; 4. Untreated and/or uncontrolled brain metastases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) of HRS-1167 | up to 24 days | — |
| Maximum tolerated dose (MTD) of HRS-1167 | up to 24 months | — |
| Recommended Phase II Dose (RP2D) of HRS-1167 | up to 24 months | — |
| AEs+SAEs | up to 24 months | from the first drug administration to within 30 days for the last treatment dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | up to 24 months | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1. |
| Evaluation of pharmacokinetic parameter of HRS-1167: Cmax | At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) | The concentration of HRS-1167 in plasma will be determined (Cmax will be derived). |
| Progression Free Survival (PFS) | up to 24 months | Time from C1D1 to first assessment of disease progression or death, whichever is earlier. |
| Duration of response (DoR) | up to 24 months | Time from documentation of tumor response to disease progression assessed among patients who had an objective response. |
| Evaluation of pharmacokinetic parameter of HRS-1167: Tmax | At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) | The concentration of HRS-1167 in plasma will be determined (Tmax will be derived). |
| Evaluation of pharmacokinetic parameter of HRS-1167: AUC | At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) | The concentration of HRS-1167 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
| Objective Response Rate (ORR) | up to 24 months | Complete response + Partial response (CR+PR) based on RECIST 1.1. |
Countries
China
Contacts
Primary ContactQuanren Wang, M.D
Outcome results
None listed