Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors

Last updated: August 28, 2024
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Overall Status: Completed

Phase

1

Condition

Neuroblastoma

Neoplasms

Treatment

SPH 3348

Clinical Study ID

NCT05088070
SPH3348-101
  • Ages > 18
  • All Genders

Study Summary

This is a phase 1 clinical trial of SPH3348 tablets, a c-Met inhibitor, in patients with advanced solid tumors with c-Met abnormalities. A modified 3 + 3 design was adopted in patients with advanced solid tumors with c-Met abnormalities, with a total of 6 dose groups, in which accelerated dose escalation was adopted for the lowest dose group, and 3

  • 3 dose escalation was adopted from the second dose group. The primary objective was to evaluate the safety and tolerability of SPH3348 tablets in patients with advanced solid tumors with c-Met abnormalities.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with advanced solid tumors with c-Met abnormalities who have failedstandard of care or are not eligible for standard therapy currently

  2. ECOG score of 0 or 1.

  3. Patients must have measurable lesion that can be assessed by imaging per RECIST 1.1criteria.

  4. Expected survival > 12 weeks.

  5. Patients must have adequate organ function

  6. Patients must give informed consent to the study and sign the informed consent formprior to the trial.

Exclusion

Exclusion Criteria:

  1. Received anti-tumor therapies, including but not limited to chemotherapy,biotherapy, radiotherapy, targeted therapy, etc., within 4 weeks prior to the firstdose of study drug; received nitrosoureas or mitomycin C within 6 weeks prior to thestart of study drug.

  2. Received small molecule tyrosine kinase inhibitors within 2 weeks prior to the firstdose.

  3. Received strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with narrowtherapeutic windows within 2 weeks prior to the start of study drug.

  4. Patients with active hepatitis B (hepatitis B surface antigen (HBsAg) positive) orhepatitis C (HCV).

  5. Toxicities caused by prior treatments have not recovered to CTCAE Grade ≤ 1 orhaving ≥Grade 2 peripheral neuropathy, except for alopecia and other events judgedas tolerable by the investigator.

  6. Known allergy to any component of the reference drug.

  7. Known drug or alcohol dependence.

  8. Received surgical treatment including surgical and interventional procedures within 4 weeks prior to the start of study drug.

  9. Patients with brain metastases.

  10. Past medical history of interstitial lung disease, drug-induced interstitial lungdisease, radiation pneumonitis which required steroid treatment, or evidence of anyclinically active interstitial lung disease.

  11. Acute bacterial, viral, or fungal infection requiring systemic therapy orunexplained fever (temperature > 38.5 °C) during screening, prior to the first dose.

  12. Neurological and psychiatric patients with obvious poor compliance.

  13. Any of the following within 6 months prior to signing of informed consent form:uncontrolled congestive cardiac failure, severe or unstable angina pectoris,myocardial infarction, stroke, coronary/peripheral artery bypass surgery, pulmonaryembolism.

  14. Arrhythmia uncontrolled by medication or sustained QTcB prolongation.

  15. Hypertension uncontrolled by medication

  16. Participated in other drug clinical studies within 28 days prior to the first doseof study drug.

  17. Women who are pregnant or in lactation period or women/men with childbearing plans.

  18. Patients who cannot take oral medication, or have previous surgical history orserious gastrointestinal diseases such as dysphagia, active gastric ulcer, which mayimpair the absorption of the study drug in the investigator's opinion.

  19. Other prior or current concomitant malignancies.

  20. Patients who are ineligible to participate in this trial for any reason judged bythe investigator.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: SPH 3348
Phase: 1
Study Start date:
July 02, 2020
Estimated Completion Date:
July 30, 2023

Connect with a study center

  • The First Affliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Site Not Available

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