Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: HRS-1167


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18； ECOG performance status 0-1; Life expectancy is not less than 12 weeks; 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； Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation； At least one target lesion (except maintenance therapy); Adequate organ and marrow function as defined by the protocol. Exclusion Criteria: Surgery or chemotherapy within 4 weeks of the first dose of study treatment； Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption； Active HBV/HCV/HIV infection; Untreated and/or uncontrolled brain metastases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRS-1167<br> | Drug: HRS-1167<br>* Participants will receive HRS-1167.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from the first drug administration to within 30 days for the last treatment dose | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetic parameter of HRS-1167: Cmax | The concentration of HRS-1167 in plasma will be determined (Cmax will be derived). | 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) | 
| Evaluation of pharmacokinetic parameter of HRS-1167: Tmax | The concentration of HRS-1167 in plasma will be determined (Tmax will be derived). | 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) | 
| Evaluation of pharmacokinetic parameter of HRS-1167: AUC | 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. | 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) | 
| Objective Response Rate (ORR) | Complete response + Partial response (CR+PR) based on RECIST 1.1. | up to 24 months | 
| Disease control rate (DCR) | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1. | up to 24 months | 
| Duration of response (DoR) | Time from documentation of tumor response to disease progression assessed among patients who had an objective response. | up to 24 months | 
| Progression Free Survival (PFS) | Time from C1D1 to first assessment of disease progression or death, whichever is earlier. | up to 24 months |