Study of CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors

A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors

This is a multicenter, open label, sequential-cohort, dose escalation & expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006 and to establish the Maximum Tolerated Dose (MTD）, if any, Recommended Phase II Doses (RP2Ds) and regimen of CS3006. The study is composed of two parts: Part 1 for dose escalation and Part 2 for dose expansion.

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: CS3006

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • People's Liberation Army 307 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent for the trial.
2. Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Able to swallow and retain oral medication.
6. Subject must have adequate organ function.
7. Use of effective contraception.

Exclusion Criteria:

1. Subjects receiving cancer therapy at the time of enrollment.
2. Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days of the first dose of investigational product administration or who has not recovered from adverse events due to a previously administered agent.
3. Previous treatment with a MEK inhibitor.
4. Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.
5. Current use of a prohibited medication.
6. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
7. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
8. Primary malignancy of the central nervous system.
9. Evidence of severe or uncontrolled systemic diseases.
10. Subjects with clinically significant cardiovascular disease.
11. Human Immunodeficiency Virus (HIV) infection.
12. Subjects with active Hepatitis B or C infection.
13. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
14. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
15. Unwillingness or inability to follow the procedures outlined in the protocol.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CS3006	Drug: CS3006; In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, participants will receive CS3006 at specified dose level(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	From the day of first dose to 30 days after last dose of CS3006

Collaborators and Investigators

• Sponsor: CStone Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2018
• Primary Completion (ACTUAL): May 15, 2020
• Study Completion (ACTUAL): May 15, 2020

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (ACTUAL): November 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 9, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CS3006-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No