Digestive System TumorsPhase 1/2NCT05139082
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
A Phase 1/2 study testing TQB3616 capsules＋ TQB2450 injection in people with Digestive System Tumors, run by Peking University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Tumors
- What is being tested?
- TQB3616 capsules＋ TQB2450 injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2021to 1 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
shen contact
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, doctorshenlin@sina.cn
Shen Lin, professor
About this study
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.
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.
- Conditions
- Digestive System Tumors
- Being tested
- TQB3616 capsules＋ TQB2450 injection
- Keywords
- PD-1/PD-L1 resistance, abnormal cell cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3616 capsules＋ TQB2450 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CDK4/6 inhibitor (TQB3616) + PD-L1 monoclonal antibody (TQB2450) | Other | TQB3616 capsules (120/150/180mg p.o. qd, d1-d21) combined with TQB2450 injection (1200mg ivgtt, d1) Receives: Drug: TQB3616 capsules＋ TQB2450 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 48 weeks
Secondary outcomes (2)
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).
Measured: up to 48 weeks
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start24 Nov 2021 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System TumorsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PD-1/PD-L1 monoclonal antibody resistance, abnormal cell cycle, digestive system tumors
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- lin shen, master, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139082
- Sponsor's protocol ID
- TQB3616-TQB2450-I/II-01
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05139082
- Acronym / sponsor ID
- TQB3616-TQB2450-I/II-01
- Conditions
- Digestive System Tumors
- Keywords
- PD-1/PD-L1 resistance, abnormal cell cycle
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 24 Nov 2021 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PD-1/PD-L1 monoclonal antibody resistance, abnormal cell cycle, digestive system tumors
| Arm | Type | Receives |
|---|---|---|
| CDK4/6 inhibitor (TQB3616) + PD-L1 monoclonal antibody (TQB2450) | Other | Drug: TQB3616 capsules＋ TQB2450 injectionTQB3616 capsules (120/150/180mg p.o. qd, d1-d21) combined with TQB2450 injection (1200mg ivgtt, d1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3616 capsules＋ TQB2450 injectionTQB3616 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. | Drug | CDK4/6 inhibitor (TQB3616) + PD-L1 monoclonal antibody (TQB2450) |
Primary outcome
Overall response rate (ORR)
Time frame: up to 48 weeks
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).
2 secondary outcomes
Disease control rate（DCR）
Time frame: up to 48 weeks
Overall survival (OS)
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shen contact
lin shen, master study chair
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB3616 capsules＋ TQB2450 injection in people with Digestive System Tumors, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, master (13911219511, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.