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

NCT06266923 | Completed Early Phase 1

• 1 other identifier: SPH6516-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• MTD（Maximum tolerated dose）

  Maximum tolerated dose

  Approximately 2 years

Secondary Outcomes (7)

• Incidence of Treatment-Emergent Adverse Events

  Approximately 2 years

• Peak Plasma Concentration (Cmax）

  Approximately 2 years

• Peak time（Tmax）

  Approximately 2 years

• Area under the plasma concentration versus time curve (AUC)

  Approximately 2 years

• half-life（T1/2）

  Approximately 2 years

Study Arms (1)

SPH6516 tablets

EXPERIMENTAL

Drug: SPH6516 tablets

Interventions

SPH6516 tablets DRUG

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

SPH6516 tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, China

Location

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: January 29, 2024
• First Posted: February 20, 2024
• Study Start: January 20, 2022
• Primary Completion: April 20, 2023
• Study Completion: November 1, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

CN (2)