SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

NCT05245058 | Recruiting Early Phase 1

• 1 other identifier: SPH5030-101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

HER2-positive Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT)

  Measurement of DLT of SPH5030 in all subjects

  Up to 24 days

• Maximum tolerated dose（MTD）

  Measurement of MTD of SPH5030 in all subjects

  Up to 24 days

• Number of patients with adverse events

  Adverse event type, incidence, duration, correlation with study drug

  Up to 2 years

Secondary Outcomes (17)

• Maximum serum concentration (Cmax) of SPH 5030

  Up to 2 years

• Time of maximum serum concentration (Tmax) SPH 5030

  Up to 2 years

• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030

  Up to 2 years

• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030

  Up to 2 years

• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030

  Up to 2 years

Study Arms (1)

SPH5030 tablets

EXPERIMENTAL

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.

Drug: SPH5030 tablets

Interventions

SPH5030 tablets DRUG

SPH5030 tablets orally once or twice daily.

SPH5030 tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status of 0 to 1.
• Life expectancy of more than 3 months.
• At least one measurable lesion exists.(RECIST 1.1)
• Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
• 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
• Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.
• Blood pregnancy test was negative within 3 days prior to first dose.

You may not qualify if:

• Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
• Known active infection within 2 weeks prior to baseline.
• Subjects with third space fluid that can not be controled.
• Subjects with uncontrolled or severe cardiovascular disease.
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
• Subjects with severe lung disease.
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
• Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
• Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
• Uncured other tumors within 5 years.
• Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
• Evidence of chronic active hepatitis B or C
• Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
• Receive any live or attenuated live vaccine within 28 days prior to baseline.
• Evidence of severe allergies.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (17)

Anhui provincial hospital

Hefei, Anhui, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Guangxi Cancer Hospital

Nanning, Guangxi, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Anyang Cancer Hospital

Anyang, Henan, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

RECRUITING

The second people's hospital of neijiang

Neijiang, China

RECRUITING

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

RECRUITING

Study Officials

• Binghe Xu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Wang

CONTACT

+8615811589825; wangxc@sphchina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: January 21, 2022
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)