Clinical trial NCT05380882: Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers
Official title: A Phase I Study of TQB2930 Injection in Patients With Advanced Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Cancers
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TQB2930 is an anti-HER2 (Human Epidermal Growth Factor Receptor 2) bispecific antibody that can simultaneously bind two epitopes of HER2, leading to a dual HER2 signal blockage. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB2930 injection in subjects with advanced malignancies.


Eligibility criteria: Inclusion Criteria:

* 1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* 2 Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
* 3 Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;
* 4 Malignant tumor that failed from standard treatment or had no standard treatment;
* 5 According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
* 6 The main organs function well;
* 7 Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion Criteria:

* 1 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years;
* 2 History of uncontrolled intercurrent illness;
* 3 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
* 4 Patients with known symptomatic brain metastases;
* 5 Receiving any other investigational agent within 4 weeks before first dose;
* 6 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: At the end of Cycle 1 (each cycle is 21 or 28 days)
measure: Maximum tolerated dose (MTD)
timeFrame: At the end of Cycle 1 (each cycle is 21 or 28 days).
measure: Adverse events (AE) rate
timeFrame: 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:
measure: immunogenicity
timeFrame: Cycle 1 Day 1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1: pre-dose and end of the infusion.(each cycle is 21 or 28 days)
measure: Pharmacokinetics: The area under the curve (AUC)
timeFrame: Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.(21 or 28 days each)
measure: Pharmacokinetics:Peak concentration (Cmax)
timeFrame: Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each
measure: Pharmacokinetics: T1/2
timeFrame: Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each
measure: Objective Response Rate (ORR)
timeFrame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
measure: Disease control rate (DCR)
timeFrame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
measure: Duration of Response (DOR)
timeFrame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
measure: Progression-free survival (PFS)
timeFrame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
measure: Overall survival(OS)
timeFrame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: