Advanced Solid TumorsPhase 1NCT04623892
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors
A Phase 1 study testing TQB2618 injection in people with Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TQB2618 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Jul 2021
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Diagnosed as advanced malignant solid tumors and have failed standard treatments or lack effective treatments; 2. 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks; 3. Has at least one measurable lesion; 4. The function of main organs is normal; 5. Female patients of childbearing age must be negative in serum or urine HCG within 7 days before enrollment in the study, and must be non-lactating; patients should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 6. Understood and signed an informed consent form.
Who cannot join
- 1. Has Autoimmune disease; 2. Has received allogeneic bone marrow transplantation or solid organ transplantation; 3. Has brain disease or brain metastases; 4. Has cavity effusion; 5. Has cardiovascular diseases; 6. Has immunodeficiency diseases; 7. Has liver disease; 8. Has infection; 9. Has diabetes; 10. Has a history of psychotropic drug abuse or have a mental disorder; 11. Have a history of severe allergy to macromolecular drugs or allergy to known components of TQB2618 injection; 12. Has other malignant tumors within 2 years before the first medication; 13. Has received other anti-cancer drugs or anti-cancer treatments, or major surgical operations within 4 weeks before the first medication; 14. Has received any live vaccines or vaccines to prevent infectious diseases within 4 weeks before the first medication; 15. Has received local radiotherapy within 1 week before the first medication; 16. Toxicity (excluding hair loss) caused by previous anti-tumor therapy that has not recovered to CTC AE V5.0 level 1 or below; 17. Has major wound, severe ulcer or fracture that has not healed before 1 day before the first medication; 18. Has used systemic hormones, immune agonists, inhibitors, and regulators before 1 day before the first medication; 19. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, 310022
About this study
Official title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors
TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of TQB2618 injection in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- TQB2618 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2618 injectionDrug
TQB2618 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2618 is diluted to 100 m with normal saline [0.9% (w/v) sodium chloride solution], and the infusion time is 60 ± 10 min.
| Study group | Role | What they receive |
|---|---|---|
| TQB2618 | Experimental | TQB2618 administered intravenously (IV) on Day 1 of each 21-day. Receives: Drug: TQB2618 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Measured: Baseline up to 28 days
Secondary outcomes (9)
Tmax
To characterize the pharmacokinetics of TQB2618 by assessment of time to reach maximum plasma concentration.
Measured: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
Cmax
Cmax is the maximum plasma concentration of TQB2618 or metabolite(s).
Measured: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
t1/2
t1/2 is time it takes for the blood concentration of TQB2618 injection or metabolite(s) to drop by half.
Measured: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
AUC0-t
To characterize the pharmacokinetics of TQB2618 by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
Receptor occupation (RO)
Receptor occupation of TIM-3 after single and multiple doses
Measured: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: Up to 48 weeks
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: Up to 48 weeks
Disease control rate（DCR）
Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measured: Up to 48 weeks
Duration of response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
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 posted10 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623892
- Sponsor's protocol ID
- TQB2618-I-01
- Status last verified
- Feb 2020
- First submitted
- 8 Nov 2020
- Last updated
- 10 Nov 2020
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04623892
- Acronym / sponsor ID
- TQB2618-I-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 10 Nov 2020 (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.
TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of TQB2618 injection in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2618 | Experimental | Drug: TQB2618 injectionTQB2618 administered intravenously (IV) on Day 1 of each 21-day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Diagnosed as advanced malignant solid tumors and have failed standard treatments or lack effective treatments; 2. 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks; 3. Has at least one measurable lesion; 4. The function of main organs is normal; 5. Female patients of childbearing age must be negative in serum or urine HCG within 7 days before enrollment in the study, and must be non-lactating; patients should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 6. Understood and signed an informed consent form.
Key exclusion criteria (1 listed)
- 1. Has Autoimmune disease; 2. Has received allogeneic bone marrow transplantation or solid organ transplantation; 3. Has brain disease or brain metastases; 4. Has cavity effusion; 5. Has cardiovascular diseases; 6. Has immunodeficiency diseases; 7. Has liver disease; 8. Has infection; 9. Has diabetes; 10. Has a history of psychotropic drug abuse or have a mental disorder; 11. Have a history of severe allergy to macromolecular drugs or allergy to known components of TQB2618 injection; 12. Has other malignant tumors within 2 years before the first medication; 13. Has received other anti-cancer drugs or anti-cancer treatments, or major surgical operations within 4 weeks before the first medication; 14. Has received any live vaccines or vaccines to prevent infectious diseases within 4 weeks before the first medication; 15. Has received local radiotherapy within 1 week before the first medication; 16. Toxicity (excluding hair loss) caused by previous anti-tumor therapy that has not recovered to CTC AE V5.0 level 1 or below; 17. Has major wound, severe ulcer or fracture that has not healed before 1 day before the first medication; 18. Has used systemic hormones, immune agonists, inhibitors, and regulators before 1 day before the first medication; 19. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
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 |
|---|---|---|
| TQB2618 injectionTQB2618 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2618 is diluted to 100 m with normal saline [0.9% (w/v) sodium chloride solution], and the infusion time is 60 ± 10 min. | Drug | TQB2618 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 28 days
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
9 secondary outcomes
Tmax
Time frame: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
Cmax
Time frame: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
t1/2
Time frame: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
AUC0-t
Time frame: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
Receptor occupation (RO)
Time frame: Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.
Overall response rate (ORR)
Time frame: Up to 48 weeks
Progression-free survival (PFS)
Time frame: Up to 48 weeks
Disease control rate（DCR）
Time frame: Up to 48 weeks
Duration of response (DOR)
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 10 Nov 2020.
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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.
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 TQB2618 injection in people with Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group 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 1 inclusion and 1 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 10 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Fan, Doctor (0571-88122510, fanyun@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Baseline up to 28 days). 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 10 Nov 2020.