SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

Early Phase 1

Recruiting

• Conditions: HER2-positive Advanced Solid Tumors
• Interventions: Drug: SPH5030 tablets

• Registration Number: NCT05245058
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-21
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-17
• Status Verified: 2024-06
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-21
• Study Completion: 2025-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPH5030 tablets	SPH5030 tablets	Subjects will take SPH5030 tablets orally on an empty stomach once or twice a day. Each subject will receive only one corresponding dose, and there were five dose groups: 50mg/ d, 100mg/ d, 200mg/ d, 300mg/ d and 400mg/ d.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Up to 24 days	Measurement of DLT of SPH5030 in all subjects
Maximum tolerated dose（MTD）	Up to 24 days	Measurement of MTD of SPH5030 in all subjects
Number of patients with adverse events	Up to 2 years	Adverse event type, incidence, duration, correlation with study drug

Secondary Outcome Measures

Name	Time	Method
Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Objective Response Rate (Investigator)	Up to 2 years	Determination of the Objective Response Rate of all patients by investigators
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Total clearance(CL) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Maximum serum concentration (Cmax) of SPH 5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Time of maximum serum concentration (Tmax) SPH 5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Half-life (t1/2) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Terminal rate constant(λz) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Disease control rate (DCR)	Up to 2 years	The proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD.
6-month Progression-free Survival (6mPFS)	Up to 2 years	Number of Patients Achieving 6-month Progression-free Survival
Volume of distribution(Vz) of SPH5030	Up to 2 years	To characterize the PK (Pharmacokinetics) of SPH 5030
Duration of remission (DOR)	Up to 2 years	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.
Progression-free survival (PFS)	Up to 2 years	The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.

Trial Locations

Locations (17)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Anyang Cancer Hospital; 🇨🇳 Anyang, Henan, China

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Xiangyang Central Hospital; 🇨🇳 Xiangyang, Hubei, China

Linyi Cancer Hospital; 🇨🇳 Linyi, Shandong, China

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, China

The second people's hospital of neijiang; 🇨🇳 Neijiang, China

Tianjin Cancer Hospital Airport Hospital; 🇨🇳 Tianjin, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Anhui provincial hospital; 🇨🇳 Hefei, Anhui, China

Guangxi Cancer Hospital; 🇨🇳 Nanning, Guangxi, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China