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Completed

NCT Number: NCT06266923

A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors.

To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sun Yat-sen University Cancer Center, Guangzhou, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced solid tumors;
  • The ECOGscore is 0 to 1.
  • Expected survival ≥3 months.
  • Good organ function before first use of the investigational drug.
  • Any toxicity associated with previous antitumor therapy must have returned to ≤ grade 1.
  • Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in person.

Exclusion criteria

  • Subjects who have received certain treatment in the prescribed period prior to their first medication;
  • Subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication;
  • Subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication;
  • Subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; Subjects with factors affecting drug administration and absorption;
  • Subjects with allergic constitution or a history of severe allergies;
  • Subjects with active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or a history of immunodeficiency;
  • Subjects with a history or evidence of high risk cardiovascular disease;
  • Subjects with severe lung disease;
  • Pregnant and lactating female subjects; Female subjects of childbearing age or male subjectswith fertile partners who were unwilling to take effective contraceptive measures throughout the entire trial period;
  • Subjects with a clear history of neurological or psychiatric disorders;
  • Other situations in which the investigator did not consider it appropriate to participate in the study.

Treatment and study plan

SPH6516 tablets

Drug

SPH6516 tablets : Orally, once daily, 25-200mg, 28 days a cycle

Primary outcomes

  1. MTD(Maximum tolerated dose)

    Time frame: Approximately 2 years

    Maximum tolerated dose

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Approximately 2 years

    Adverse event type, incidence, duration

  2. Peak Plasma Concentration (Cmax)

    Time frame: Approximately 2 years

    PK (Pharmacokinetics)

  3. Peak time(Tmax)

    Time frame: Approximately 2 years

    PK (Pharmacokinetics)

  4. Area under the plasma concentration versus time curve (AUC)

    Time frame: Approximately 2 years

    PK (Pharmacokinetics)

  5. half-life(T1/2)

    Time frame: Approximately 2 years

    PK (Pharmacokinetics)

  6. Objective response rate(ORR)

    Time frame: Approximately 2 years

    Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1

  7. Progression-free survival (PFS)

    Time frame: Approximately 2 years

    The interval between the date of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of SPH6516 Tablets in Subjects With Advanced Solid Tumors.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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