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Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors

Primary Purpose

Digestive System Tumors

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB3616 capsules+ TQB2450 injection
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digestive System Tumors focused on measuring PD-1/PD-L1 resistance, abnormal cell cycle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Voluntary participation and written informed consent;
  2. Age ≥ 18 years old;
  3. No gender limitation;
  4. Digestive system malignant tumor diagnosed by pathology;
  5. Digestive system tumor patients who have failed standard treatment;
  6. Patients with PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment failure;
  7. Abnormal cell cycle signaling pathways
  8. Patients with unresectable digestive system tumors confirmed by imaging;
  9. There is at least one measurable lesion (according to the RECIST1.1 standard) or an unmeasurable lesion that can be evaluated, and the imaging diagnosis is ≤21 days from the selection time;
  10. The expected survival period is ≥3 months;
  11. General physical status (ECOG) 0-2;
  12. Sufficient bone marrow hematopoietic function (within 7 days);
  13. Heart, lung, kidney, and liver functions are generally normal.
  14. Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; men should agree to use effective contraception during the study period and after the end of the study period 6 Effective contraceptive measures must be used within one month.

Exclusion Criteria:

  1. People who are currently receiving other effective treatments;
  2. Patients who are using immunosuppressive agents or systemic or absorptive local hormone therapy to achieve immunosuppression within 2 weeks before the first medication;
  3. Patients who have participated in other clinical trials within 4 weeks before enrollment;
  4. Allergic to study drugs; 5 . Those without measurable tumor lesions, such as body cavity effusion or diffuse infiltration of organs;

6. Those with measurable lesions that have received radiotherapy. 7. Patients with other primary malignant tumors other than digestive system tumors at the same time, except for early solid tumors that have been cured for more than 1 year; 8. Clinically significant cardiovascular diseases, such as heart failure (NYHAIII-IV), are not controlled A history of coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or myocardial infarction within the past 1 year; 9. Neurological or mental disorders that affect cognitive ability, including central nervous system metastasis; 10. Existed within 14 days before enrollment Active severe clinical infections (>grade 2 NCI-CTCAE version 5.0), including active tuberculosis; 11. Known or self-reported HIV infection or active hepatitis B or C; 12. Uncontrolled Systemic diseases, such as poorly controlled diabetes; 13. A history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest X-ray/CT; 14. Keratitis , Ulcerative keratitis or severe dry eye; 15. Known hypersensitivity or allergic reaction to any component of the study drug; 16. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding.

Sites / Locations

  • Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CDK4/6 inhibitor (TQB3616) + PD-L1 monoclonal antibody (TQB2450)

Arm Description

TQB3616 capsules (120/150/180mg p.o. qd, d1-d21) combined with TQB2450 injection (1200mg ivgtt, d1)

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 or iRECIST (CR under iRECIST criteria, PR can occur after imaging disease progression).

Secondary Outcome Measures

Disease control rate(DCR)
Disease control rate refers to the percentage of subjects with complete remission, partial remission, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression).
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.

Full Information

First Posted
November 11, 2021
Last Updated
November 24, 2021
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT05139082
Brief Title
Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors
Official Title
A Phase I/II Phase Evaluating the Effectiveness and Safety of CDK4/6 Inhibitor (TQB3616) Combined With PD-L1 Monoclonal Antibody (TQB2450) in the Treatment of PD-1/PD-L1 Monoclonal Antibody Resistance and Abnormal Cell Cycle Digestive System Tumors.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 24, 2021 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study intends to explore the effectiveness and safety of CDK4/6 inhibitor (TQB3616) combined with PD-L1 monoclonal antibody (TQB2450) in the treatment of PD-1/PD-L1 monoclonal antibody resistance and abnormal cell cycle digestive system tumors, through prospective Explore to provide more evidence-based medical evidence for precision immunotherapy for patients with digestive system tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Tumors
Keywords
PD-1/PD-L1 resistance, abnormal cell cycle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
PD-1/PD-L1 monoclonal antibody resistance, abnormal cell cycle, digestive system tumors
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDK4/6 inhibitor (TQB3616) + PD-L1 monoclonal antibody (TQB2450)
Arm Type
Other
Arm Description
TQB3616 capsules (120/150/180mg p.o. qd, d1-d21) combined with TQB2450 injection (1200mg ivgtt, d1)
Intervention Type
Drug
Intervention Name(s)
TQB3616 capsules+ TQB2450 injection
Intervention Description
TQB3616 is a highly active CDK4/6 inhibitor. Preclinical studies have shown that it has a strong inhibitory effect on the kinase activity of CDK4/6. TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 or iRECIST (CR under iRECIST criteria, PR can occur after imaging disease progression).
Time Frame
up to 48 weeks
Secondary Outcome Measure Information:
Title
Disease control rate(DCR)
Description
Disease control rate refers to the percentage of subjects with complete remission, partial remission, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression).
Time Frame
up to 48 weeks
Title
Overall survival (OS)
Description
Overall survival defined as the time from enrollment to death from any cause.
Time Frame
up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary participation and written informed consent; Age ≥ 18 years old; No gender limitation; Digestive system malignant tumor diagnosed by pathology; Digestive system tumor patients who have failed standard treatment; Patients with PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment failure; Abnormal cell cycle signaling pathways Patients with unresectable digestive system tumors confirmed by imaging; There is at least one measurable lesion (according to the RECIST1.1 standard) or an unmeasurable lesion that can be evaluated, and the imaging diagnosis is ≤21 days from the selection time; The expected survival period is ≥3 months; General physical status (ECOG) 0-2; Sufficient bone marrow hematopoietic function (within 7 days); Heart, lung, kidney, and liver functions are generally normal. Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; men should agree to use effective contraception during the study period and after the end of the study period 6 Effective contraceptive measures must be used within one month. Exclusion Criteria: People who are currently receiving other effective treatments; Patients who are using immunosuppressive agents or systemic or absorptive local hormone therapy to achieve immunosuppression within 2 weeks before the first medication; Patients who have participated in other clinical trials within 4 weeks before enrollment; Allergic to study drugs; 5 . Those without measurable tumor lesions, such as body cavity effusion or diffuse infiltration of organs; 6. Those with measurable lesions that have received radiotherapy. 7. Patients with other primary malignant tumors other than digestive system tumors at the same time, except for early solid tumors that have been cured for more than 1 year; 8. Clinically significant cardiovascular diseases, such as heart failure (NYHAIII-IV), are not controlled A history of coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or myocardial infarction within the past 1 year; 9. Neurological or mental disorders that affect cognitive ability, including central nervous system metastasis; 10. Existed within 14 days before enrollment Active severe clinical infections (>grade 2 NCI-CTCAE version 5.0), including active tuberculosis; 11. Known or self-reported HIV infection or active hepatitis B or C; 12. Uncontrolled Systemic diseases, such as poorly controlled diabetes; 13. A history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest X-ray/CT; 14. Keratitis , Ulcerative keratitis or severe dry eye; 15. Known hypersensitivity or allergic reaction to any component of the study drug; 16. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, master
Phone
13911219511
Email
doctorshenlin@sina.cn
First Name & Middle Initial & Last Name or Official Title & Degree
shen
Email
doctorshenlin@sina.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lin shen, master
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Lin, Professor
Phone
010-88196561
Email
doctorshenlin@sina.cn
First Name & Middle Initial & Last Name & Degree
Shen Lin, professor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors

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