A Phase I, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activities of CS3002, a CDK4/6 Inhibitor, in Subjects With Advanced Solid Tumors

CStone Pharmaceuticals2 sites in 1 country10 target enrollmentDecember 30, 2019

ConditionsAdvanced Solid Tumor

InterventionsCS3002

DrugsCS3002

Overview

Phase: Phase 1
Intervention: CS3002
Conditions: Advanced Solid Tumor
Sponsor: CStone Pharmaceuticals
Enrollment: 10
Locations: 2
Primary Endpoint: Number of participants with adverse events as assessed by CTCAE v5.0
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS3002 in subjects with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

December 30, 2019

End Date

February 19, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

CStone Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.
•Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
•Male or female and ≥ 18 years of age on the day of signing informed consent.
•Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor (except SCLC and HPV positive tumors), who has experienced disease progression following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
•Subjects with at least one measurable lesion as defined per RECIST v1.1 (only bone metastasis or CNS as measurable focus is not allowed).
•ECOG performance status ≤
•Able to swallow and retain oral medication.
•Subject must have adequate organ function as indicated by the following laboratory values, under the circumstance of not receiving blood transfusion, EPO, Granulocyte Colony-Stimulating Factor (G-CSF) or other medical support within 14 days before study drug administration
•Non-pregnant and non-nursing. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of CS3002 (WOCBP is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 months). WOCBP must agree to remain abstinent (refrain from heterosexual intercourse) or use an acceptable contraceptive method (refer to Appendix 6) from the day of signing informed consent, during the treatment period and for at least 90 days after the last dose of study drug.
•Men must agree to remain abstinent (refrain from heterosexual intercourse) or use an acceptable contraceptive method (refer to Appendix 6) from the day of signing informed consent, during the treatment period and for at least 90 days after the last dose of study drug. Men must refrain from donating sperm during this same period.

Exclusion Criteria

•Prior treatment with any CDK4/6 inhibitor.
•Participation in other studies involving investigational drug(s) within 28 days prior to the first dose of CS3002 and/or during study participation.
•Acceptance of major surgery, chemotherapy, radiotherapy, target therapy, immunotherapy or other anti-cancer therapy within 21 days prior to the first dose of CS
•Prior treatment with drugs that are known to prolong the QT interval within 7 days before the first dose of CS
•Concomitant use of products known to prolong the QT interval or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued ≥ 5 half-lives prior to first dose of CS3002 and withheld throughout the trial until 2 weeks after the last dose of CS
•Any toxic effects of prior anti-cancer therapy or surgical procedures unresolved to baseline severity or NCI-CTCAE Version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion)
•Diagnosis of any other malignancy within 3 years prior to the first dose of CS3002, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
•Diagnosis of small cell lung cancer and HPV positive tumors.
•Known brain metastasis or other central nervous system (CNS) metastasis that is either symptomatic or untreated. CNS metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by imaging for at least 4 weeks before screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to CS3002, or any of its excipients (refer to Section 6.2.1).

Arms & Interventions

CS3002 CDK4/6 inhibitor

Intervention: CS3002

Outcomes

Primary Outcomes

Number of participants with adverse events as assessed by CTCAE v5.0

Time Frame: Subjects will be monitored for safety and tolerability throughout the study until 30 ±3 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first.

incidence rate and characteristics of dose-limiting toxicity (DLT); incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes of laboratory values, vital signs and electrocardiogram (ECG) findings. And based on the safety, tolerability, pharmacokinetics, preliminary efficacy, and other available data to determine MTD, RP2D and regimen for CS3002.