MelanomaPhase 1NCT05451407
Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
A Phase 1 study testing TQB2618 injection and Toripalimab injection in people with Melanoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- TQB2618 injection and Toripalimab 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
- 9 Aug 2022to Dec 2023
- 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 Age: 18-75 years old;ECOG PS score: 0~1;The expected survival is over 3 months
- 2 Patients with advanced melanoma diagnosed histologically and/or cytologically
- 3 At least one measurable lesion was confirmed according to RECIST 1.1 criteria
- 4 Major organs are functioning normally
- 5 Female subjects of reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study;Negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;Male subjects should agree to use contraception during the study and for six months after the end of the study period
Who cannot join
- 1 Present or present with other malignant tumors within 3 years prior to first use
- 2 Unalleviated toxicity above CTCAE grade 1 due to any prior treatment
- 3 Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration
- 4 A wound or fracture that has not healed for a long time
- 5 Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders
- 6 Subject with any severe and/or uncontrolled disease
- 7 Prior chemotherapy within 3 weeks prior to initial drug use, and prior radiotherapy or other antineoplastic drugs within 2 weeks prior to initial drug use
- 8 Those who have participated in and used other antitumor clinical trials within 4 weeks prior to the first drug use
Trial locations and contacts
1 site in 1 country.
SiMing Li, Doctor contact
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, 13911233048, guoj307@126.com
About this study
Official title: Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.
- Conditions
- Melanoma
- Being tested
- TQB2618 injection, Toripalimab injection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2618 injectionDrug
Humanized IgG4 mab targeting TIM-3
Toripalimab injectionDrug
Monoclonal antibody against Programmed death factor receptor 1
| Study group | Role | What they receive |
|---|---|---|
| TQB2618 injection combined with Toripalimab injection | Experimental | TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle. Receives: Drug: TQB2618 injection; Drug: Toripalimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose
Measured: Initial administration up to 21 days
phase II recommended dose
Optimal tolerated dose determined after the end of phase 1
Measured: At the end of phase I, 1 subject received the first dose up to 21 days
objective response rate
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)
Measured: Baseline up to 96weeks
Secondary outcomes (3)
Progression-Free Survival
The time between the onset of first medication and disease progression (PD) or death before PD
Measured: disease progression before death,no more than 100 months
Disease Control Rate
The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated
Measured: Baseline up to 96 weeks
Overall Survival
From the time of the patient's first treatment to the time of death from any cause
Measured: No more than 100 months from the beginning of the first dose to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start9 Aug 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- NCT05451407
- Sponsor's protocol ID
- TQB2618-Ib-01
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2022
- Last updated
- 7 Jul 2023
- 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 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT05451407
- Acronym / sponsor ID
- TQB2618-Ib-01
- Conditions
- Melanoma
- 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
- 9 Aug 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Jul 2022 (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 an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2618 injection combined with Toripalimab injection | Experimental | Drug: TQB2618 injection, Drug: Toripalimab injectionTQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1 Age: 18-75 years old;ECOG PS score: 0~1;The expected survival is over 3 months
- 2 Patients with advanced melanoma diagnosed histologically and/or cytologically
- 3 At least one measurable lesion was confirmed according to RECIST 1.1 criteria
- 4 Major organs are functioning normally
- 5 Female subjects of reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study;Negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;Male subjects should agree to use contraception during the study and for six months after the end of the study period
Key exclusion criteria (8 listed)
- 1 Present or present with other malignant tumors within 3 years prior to first use
- 2 Unalleviated toxicity above CTCAE grade 1 due to any prior treatment
- 3 Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration
- 4 A wound or fracture that has not healed for a long time
- 5 Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders
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 injectionHumanized IgG4 mab targeting TIM-3 | Drug | TQB2618 injection combined with Toripalimab injection |
| Toripalimab injectionMonoclonal antibody against Programmed death factor receptor 1 | Drug | TQB2618 injection combined with Toripalimab injection |
Primary outcome
Dose-limiting toxicity
Time frame: Initial administration up to 21 days
Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose
phase II recommended dose
Time frame: At the end of phase I, 1 subject received the first dose up to 21 days
Optimal tolerated dose determined after the end of phase 1
objective response rate
Time frame: Baseline up to 96weeks
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)
3 secondary outcomes
Progression-Free Survival
Time frame: disease progression before death,no more than 100 months
Disease Control Rate
Time frame: Baseline up to 96 weeks
Overall Survival
Time frame: No more than 100 months from the beginning of the first dose to death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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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.
SiMing Li, Doctor contact
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 and Toripalimab injection in people with Melanoma, 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 5 inclusion and 8 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 7 Jul 2023. 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 Jun Guo, Doctor (13911233048, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Initial administration up to 21 days). The study lists 3 primary outcomes in all. 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 7 Jul 2023.