Recruiting NCT05473624
Study of HRS-1167 as Monotherapy in Patients With 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-1167.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 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 →
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Official title
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
Overview
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
- Drug HRS-1167
Participants will receive HRS-1167.
Primary outcome measures
- Dose-limiting toxicity (DLT) of HRS-1167 [Time frame: up to 24 days]
- Maximum tolerated dose (MTD) of HRS-1167 [Time frame: up to 24 months]
- Recommended Phase II Dose (RP2D) of HRS-1167 [Time frame: up to 24 months]
- AEs+SAEs [Time frame: up to 24 months]
Secondary outcome measures (7)
- Evaluation of pharmacokinetic parameter of HRS-1167: Cmax [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: up to 24 months]
- Disease control rate (DCR) [Time frame: up to 24 months]
- Duration of response (DoR) [Time frame: up to 24 months]
- Progression Free Survival (PFS) [Time frame: up to 24 months]
Eligibility criteria
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.
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 · 20 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Chongqing Cancer Hospital — Chongqing
- Guangxi Medical University Affiliated Tumor Hosipital — Nanning
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou
- Harbin Medical University Cancer Hospital — Harbin
- Henan Cancer Hospital — Zhengzhou
- Hunan Cancer Hospital — Changsha
- Hunan Cancer Hospital — Changsha
- … and 12 more centers
Identifiers
NCT: NCT05473624 · HRS-1167-I-101