Clinical trial NCT05245058: SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: HER2-positive Advanced Solid Tumors
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 24 days
measure: Maximum tolerated dose（MTD）
timeFrame: Up to 24 days
measure: Number of patients with adverse events
timeFrame: Up to 2 years
Secondary outcomes:
measure: Maximum serum concentration (Cmax) of SPH 5030
timeFrame: Up to 2 years
measure: Time of maximum serum concentration (Tmax) SPH 5030
timeFrame: Up to 2 years
measure: Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030
timeFrame: Up to 2 years
measure: Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030
timeFrame: Up to 2 years
measure: Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030
timeFrame: Up to 2 years
measure: Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030
timeFrame: Up to 2 years
measure: Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030
timeFrame: Up to 2 years
measure: Terminal rate constant(λz) of SPH5030
timeFrame: Up to 2 years
measure: Half-life (t1/2) of SPH5030
timeFrame: Up to 2 years
measure: Total clearance(CL) of SPH5030
timeFrame: Up to 2 years
measure: Volume of distribution(Vz) of SPH5030
timeFrame: Up to 2 years
measure: Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030
timeFrame: Up to 2 years
measure: Objective Response Rate (Investigator)
timeFrame: Up to 2 years
measure: Duration of remission (DOR)
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: 6-month Progression-free Survival (6mPFS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui provincial hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi Cancer Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
city: Neijiang
country: China
facility: The second people's hospital of neijiang
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Binghe Xu
role: PRINCIPAL_INVESTIGATOR
References: