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CompletedNCT03736850Updated Jan 12, 2021

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

A Phase 1 interventional study of CS3006 in Locally Advanced or Metastatic Solid Tumors, sponsored by CStone Pharmaceuticals. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-12.

Sponsored by CStone Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Locally Advanced or Metastatic Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 17 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

CStone Pharmaceuticals is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    CS3006

    Drug: CS3006

Interventions

  • DrugCS3006

    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).

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

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

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Study locations

1 site
  • People's Liberation Army 307 Hospital
    Beijing, Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03736850
Lead sponsor
CStone Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 9, 2018
Start date
Oct 19, 2018
Primary completion
May 15, 2020
Completion
May 15, 2020
Last update
Jan 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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