Study of 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.

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Key information

Conditions

Locally Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

People's Liberation Army 307 Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Subjects receiving cancer therapy at the time of enrollment.
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.
Previous treatment with a MEK inhibitor.
Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.
Current use of a prohibited medication.
Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
Primary malignancy of the central nervous system.
Evidence of severe or uncontrolled systemic diseases.
Subjects with clinically significant cardiovascular disease.
Human Immunodeficiency Virus (HIV) infection.
Subjects with active Hepatitis B or C infection.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
Unwillingness or inability to follow the procedures outlined in the protocol.

For more information regarding trial participation, please contact at [email protected]

Treatment and study plan

CS3006

Drug

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).

Primary outcomes

Number of participants with adverse events

Time frame: From the day of first dose to 30 days after last dose of CS3006

Sponsors and collaborators

Lead sponsor

CStone Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Nov 9, 2018
Registry last updated: Jan 12, 2021

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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Completed