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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473624
• Other study ID #: HRS-1167-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 23, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Quanren Wang, M.D
• Phone: +86 18036618570
• Email: quanren.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• HRS-1167
Participants will receive HRS-1167.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangzhou
China	Zhejiang Cancer Hospital	Hangzhou	Zhengjiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Qilu Hospital of Shandong University	Jinan	Shangdong
China	Shandong Cancer Hospital	Jinan	Shangdong
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hosipital	Nanning	Guangxi
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT) of HRS-1167		up to 24 days
Primary	Maximum tolerated dose (MTD) of HRS-1167		up to 24 months
Primary	Recommended Phase II Dose (RP2D) of HRS-1167		up to 24 months
Primary	AEs+SAEs	from the first drug administration to within 30 days for the last treatment dose	up to 24 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Objective Response Rate (ORR)	Complete response + Partial response (CR+PR) based on RECIST 1.1.	up to 24 months
Secondary	Disease control rate (DCR)	Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1.	up to 24 months
Secondary	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
Secondary	Progression Free Survival (PFS)	Time from C1D1 to first assessment of disease progression or death, whichever is earlier.	up to 24 months