SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

HER2-positive Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245058
• Other study ID #: SPH5030-101
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 21, 2022
• Est. completion date: June 21, 2024

Study information

• Verified date: June 2024
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: Xingchen Wang
• Phone: +8615811589825
• Email: wangxc[@]sphchina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: June 21, 2024
• Est. primary completion date: June 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ECOG performance status of 0 to 1.

2. Life expectancy of more than 3 months.

3. At least one measurable lesion exists.(RECIST 1.1)

4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.

5. Required laboratory values including following parameters:

ANC: = 1.5 x 109/L Plt count: = 90x 109/L Hb: = 90 g/L TBIL: = 1.5 x ULN, ALT and AST:

= 2.5 x ULN and creatine clearance rate: ULN or= 50 mL/min

6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE= class 1.

7. Blood pregnancy test was negative within 3 days prior to first dose.

Exclusion Criteria:

1. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.

2. Known active infection within 2 weeks prior to baseline.

3. Subjects with third space fluid that can not be controled by drainage or other methods.

4. Subjects with uncontrolled or severe cardiovascular disease.

5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.

6. Subjects with severe lung disease.

7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.

8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.

9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids.

10. Uncured other tumors within 5 years.

11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.

12. Evidence of chronic active hepatitis B or C

13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.

14. Receive any live or attenuated live vaccine within 28 days prior to baseline.

15. Evidence of severe allergies.

16. Evidence of alcohol or drug abuse.

17. Evidence of neurological or psychiatric disorders.

Related Conditions & MeSH terms

• HER2-positive Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• SPH5030 tablets
SPH5030 tablets orally once or twice daily.

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	Henan
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical University	Bengbu
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui provincial hospital	Hefei	Anhui
China	Linyi Cancer Hospital	Linyi	Shandong
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Guangxi Cancer Hospital	Nanning	Guangxi
China	The second people's hospital of neijiang	Neijiang
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Cancer Hospital Airport Hospital	Tianjin
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)	Measurement of DLT of SPH5030 in all subjects	Up to 24 days
Primary	Maximum tolerated dose(MTD)	Measurement of MTD of SPH5030 in all subjects	Up to 24 days
Primary	Number of patients with adverse events	Adverse event type, incidence, duration, correlation with study drug	Up to 2 years
Secondary	Maximum serum concentration (Cmax) of SPH 5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Time of maximum serum concentration (Tmax) SPH 5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Terminal rate constant(?z) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Half-life (t1/2) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Total clearance(CL) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Volume of distribution(Vz) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030	To characterize the PK (Pharmacokinetics) of SPH 5030	Up to 2 years
Secondary	Objective Response Rate (Investigator)	Determination of the Objective Response Rate of all patients by investigators	Up to 2 years
Secondary	Duration of remission (DOR)	Time from first documentation of objective response (CR or PR) to first documentation of PD/death due to any cause in absence of documented PD, based on central radiology review as per RECIST v1.1.	Up to 2 years
Secondary	Disease control rate (DCR)	The proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD.	Up to 2 years
Secondary	Progression-free survival (PFS)	The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.	Up to 2 years
Secondary	6-month Progression-free Survival (6mPFS)	Number of Patients Achieving 6-month Progression-free Survival	Up to 2 years