A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

Phase I Clinical Study on the Safety and Tolerability of a CDK4 / 6 Inhibitor and a MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04615312

Enrollment

Registered

2020-11-04

Start date

2020-11-14

Completion date

2022-08-30

Last updated

2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Tumors

Brief summary

This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors

Interventions

DRUGa CDK4 / 6 inhibitor and a MEK inhibitor

Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Aged 18-75 years; 2. ECOG score ≤ 1; 3. Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis; 4. According to Recist1.1, there was at least one measurable lesion; 5. The expected survival time was more than 12 weeks;

Exclusion criteria

1. Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial; 2. Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors; 3. The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods; 4. Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug; 5. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy	Up to approximately 24 months

Secondary

Measure	Time frame	Description
ORR	Up to approximately 24 months	the Objective Remission Rate

Countries

China

Contacts

Primary ContactNing Li, PhD

lining97@126.com13526501903

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026