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

NCT05088070 | Completed Phase 1

• 1 other identifier: SPH3348-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Incidence of DLT in all subjects.

  24 days

• Maximum tolerated dose (MTD)

  Measurement of MTD in all subjects.

  24 days

Secondary Outcomes (9)

• Maximum serum concentration (Cmax) of SPH 3348.

  24 days

• Time of maximum serum concentration (Tmax) SPH 3348.

  24 days

• Area under the concentration-time curve (AUC) of SPH 3348.

  24 days

• Half-life (t1/2) of SPH 3348.

  24 days

• Objective Response Rate (ORR)

  24 days

Study Arms (1)

SPH 3348 tablets

EXPERIMENTAL

6 different dosage group of SPH 3348 will be assigned with 16mg, 40mg, 80mg, 160mg, 240mg and 320mg respectively.

Drug: SPH 3348

Interventions

SPH 3348 DRUG

2 tablets of 8mg SPH3348 will be orally administered once a day with empty stomach

SPH 3348 tablets

Eligibility Criteria

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

You may qualify if:

• Patients with advanced solid tumors with c-Met abnormalities who have failed standard of care or are not eligible for standard therapy currently
• ECOG score of 0 or 1.
• Patients must have measurable lesion that can be assessed by imaging per RECIST 1.1 criteria.
• Expected survival \> 12 weeks.
• Patients must have adequate organ function
• Patients must give informed consent to the study and sign the informed consent form prior to the trial.

You may not qualify if:

• Received anti-tumor therapies, including but not limited to chemotherapy, biotherapy, radiotherapy, targeted therapy, etc., within 4 weeks prior to the first dose of study drug; received nitrosoureas or mitomycin C within 6 weeks prior to the start of study drug.
• Received small molecule tyrosine kinase inhibitors within 2 weeks prior to the first dose.
• Received strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with narrow therapeutic windows within 2 weeks prior to the start of study drug.
• Patients with active hepatitis B (hepatitis B surface antigen (HBsAg) positive) or hepatitis C (HCV).
• Toxicities caused by prior treatments have not recovered to CTCAE Grade ≤ 1 or having ≥Grade 2 peripheral neuropathy, except for alopecia and other events judged as tolerable by the investigator.
• Known allergy to any component of the reference drug.
• Known drug or alcohol dependence.
• Received surgical treatment including surgical and interventional procedures within 4 weeks prior to the start of study drug.
• Patients with brain metastases.
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or evidence of any clinically active interstitial lung disease.
• Acute bacterial, viral, or fungal infection requiring systemic therapy or unexplained fever (temperature \> 38.5 °C) during screening, prior to the first dose.
• Neurological and psychiatric patients with obvious poor compliance.
• 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, pulmonary embolism.
• Arrhythmia uncontrolled by medication or sustained QTcB prolongation.
• Hypertension uncontrolled by medication

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

The First Affliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Study Officials

• Zishu Wang

  The First Affliated Hospital of Bengbu Medical College

  PRINCIPAL INVESTIGATOR

• Huan Zhou

  The First Affliated Hospital of Bengbu Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 21, 2021
• Study Start: July 2, 2020
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)