Evaluating SPH5030 tablets for advanced HER2-positive solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and tolerability of SPH5030 tablets in patients with advanced HER2-positive solid tumors. Participants must have measurable lesions and a confirmed diagnosis of HER2-positive metastatic solid tumors that have either failed prior treatments or lack standard treatment options. The study will monitor various health parameters to ensure participant safety and evaluate the drug's effects. It is an early-phase trial, indicating that it is among the first steps in testing this new treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Anhui provincial hospital
  Hefei, Anhui, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, 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

Study contacts

• Principal investigator: Binghe Xu — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Xingchen Wang
• Email: wangxc@sphchina.com
• Phone: +8615811589825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.