SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · Feb 9, 2022

Keywords

ClinConnect Summary

The clinical trial titled "SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors" is studying a new medication called SPH5030 to see how safe it is for patients with advanced HER2-positive solid tumors, which are a type of cancer that has not responded to standard treatments. The trial is currently recruiting participants who are between the ages of 65 and 74, and both men and women can join. To be eligible, participants should have a good performance status, meaning they are relatively healthy and can carry out daily activities, and they need to have a life expectancy of more than three months. Additionally, they must have at least one measurable tumor and have confirmed HER2-positive cancer.

If someone joins this study, they can expect to take SPH5030 tablets and be monitored closely for any side effects or issues. It’s important to note that there are certain health conditions that would exclude someone from participating, such as severe heart disease, uncontrolled infections, or issues with swallowing tablets. This trial aims to learn more about how well SPH5030 works and its safety profile, which could help improve treatment options for patients with this type of cancer in the future.

Gender

ALL

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.