NCT04623892UnknownPhase 1
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
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country50 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose (MTD)
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed as advanced malignant solid tumors and have failed standard treatments or lack effective treatments;
- •18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks;
- •Has at least one measurable lesion;
- •The function of main organs is normal;
- •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;
- •Understood and signed an informed consent form.
Exclusion Criteria
- •Has Autoimmune disease;
- •Has received allogeneic bone marrow transplantation or solid organ transplantation;
- •Has brain disease or brain metastases;
- •Has cavity effusion;
- •Has cardiovascular diseases;
- •Has immunodeficiency diseases;
- •Has liver disease;
- •Has infection;
- •Has diabetes;
- •Has a history of psychotropic drug abuse or have a mental disorder;
- •Have a history of severe allergy to macromolecular drugs or allergy to known components of TQB2618 injection;
- •Has other malignant tumors within 2 years before the first medication;
- •Has received other anti-cancer drugs or anti-cancer treatments, or major surgical operations within 4 weeks before the first medication;
- •Has received any live vaccines or vaccines to prevent infectious diseases within 4 weeks before the first medication;
- •Has received local radiotherapy within 1 week before the first medication;
- •Toxicity (excluding hair loss) caused by previous anti-tumor therapy that has not recovered to CTC AE V5.0 level 1 or below;
- •Has major wound, severe ulcer or fracture that has not healed before 1 day before the first medication;
- •Has used systemic hormones, immune agonists, inhibitors, and regulators before 1 day before the first medication;
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Arms & Interventions
TQB2618
Experimental
TQB2618 administered intravenously (IV) on Day 1 of each 21-day.
Intervention: TQB2618 injection (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Duration of response (DOR)(Up to 48 weeks)
- t1/2(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(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)(Up to 48 weeks)
- Progression-free survival (PFS)(Up to 48 weeks)
- Disease control rate（DCR）(Up to 48 weeks)
- Tmax(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(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)(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.)
Investigators
Study Sites (1)
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