Advanced CancersPhase 1NCT06649656
A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors
A Phase 1 study testing TQB2252 injection in people with Advanced Cancers, run by Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- TQB2252 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
- 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form);
- Electrocorticogram (ECOG) score ranges from 0 to 1 points;
- Expected survival is greater than 12 weeks；
- Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria；
- Late stage malignant tumor subjects who have failed standard treatment or lack effective treatment；
- Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; Men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period.
Who cannot join
- Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication;
- There are multiple factors that affect diseases related to intravenous injection and venous blood collection;
- The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1;
- Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication;
- Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration;
- An arterial/venous thrombotic event occurred within 6 months prior to the first administration;
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- Active viral hepatitis with poor control;
- Active syphilis infected individuals in need of treatment;
- History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy;
- Previously experienced grade 3 or higher adverse reactions related to immunotherapy;
- Suffering from significant cardiovascular disease;
- Active or uncontrolled severe infections;
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
- Individuals with epilepsy who require treatment;
- Previously received treatment with similar anti-lag3 drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong provincial people's hospital
Guangzhou, Guangdong, 519041
Xing Zhang, Doctor, 13610223691, zhangxing@sysucc.org.cn
About this study
This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.
- Conditions
- Advanced Cancers
- Being tested
- TQB2252 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2252 injectionDrug
TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle.
| Study group | Role | What they receive |
|---|---|---|
| TQB2252 injection | Experimental | This product is administered via intravenous infusion, with recommended doses of 600mg TQB2223 monoclonal antibody and 200mg penpulimab injection, administered once every 3 weeks. Receives: Drug: TQB2252 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE) rate
The evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0).
Measured: From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.
Secondary outcomes (7)
Time to reach maximum observed plasma concentration (Tmax)
Time to reach maximum (peak) plasma concentration following drug administration
Measured: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration of TQB2252.
Measured: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)
Elimination half-life (t1/2)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)
Objective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
Measured: up to 2 years
Progression-free survival (PFS)
Defined as the time from the first dose of TQB2252 to the first occurrence of disease progression or death from any cause.
Measured: up to 2 years
Disease control rate (DCR)
Defined as the proportion of subjects with CR, PR, or Stable Disease (SD).
Measured: up to 2 years
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649656
- Sponsor's protocol ID
- TQB2252-I-01
- Status last verified
- Jun 2024
- First submitted
- 17 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06649656
- Acronym / sponsor ID
- TQB2252-I-01
- Conditions
- Advanced Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Oct 2024 (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 is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2252 injection | Experimental | Drug: TQB2252 injectionThis product is administered via intravenous infusion, with recommended doses of 600mg TQB2223 monoclonal antibody and 200mg penpulimab injection, administered once every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
- 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form);
- Electrocorticogram (ECOG) score ranges from 0 to 1 points;
- Expected survival is greater than 12 weeks；
- Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria；
Key exclusion criteria (18 listed)
- Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication;
- There are multiple factors that affect diseases related to intravenous injection and venous blood collection;
- The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1;
- Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication;
- Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration;
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 |
|---|---|---|
| TQB2252 injectionTQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle. | Drug | TQB2252 injection |
Primary outcome
Adverse events (AE) rate
Time frame: From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.
The evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0).
7 secondary outcomes
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)
Maximum Plasma Concentration (Cmax)
Time frame: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)
Elimination half-life (t1/2)
Time frame: Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days)
Objective Response Rate (ORR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2252 injection in people with Advanced Cancers, run by Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd. 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 7 inclusion and 18 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: opening soon, as of the sponsor's last update on 21 Oct 2024. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xing Zhang, Doctor (13610223691, zhangxing@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) rate (time frame: From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.). 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 21 Oct 2024.