Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

Advanced Cancer Clinical Trial

Official title:

A Phase I Study of TQB2102 Injection in Patients With Advanced Cancers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05735496
• Other study ID #: TQB2102-I-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 2023
• Est. completion date: October 2024

Study information

• Verified date: June 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Ruihua Xu, Doctor
• Phone: +86-20-87343468
• Email: ruihxu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB102 injection in subjects with advanced malignancies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 71
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;

• 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;

• Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;

• Malignant tumor that failed from standard treatment or had no standard treatment;

• According to the RECIST 1.1 standard, patient with at least one evaluable lesion;

• The main organs function well;

• 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:

• Concurrent secondary malignancy or other malignancy with no evidence of disease for more than 3 years;

• History of uncontrolled intercurrent illness;

• Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;

• Patients with known symptomatic brain metastases;

• Receiving any other investigational agent within 4 weeks before first dose;

• Patients with severe hypersensitivity after the use of monoclonal antibodies

• History of interstitial lung disease or pneumonia;

• Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• TQB2102 injection
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)	DLT was defined as toxicities that meet pre-defined severity criteria (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle (21 days) of treatment.	During the first treatment cycle (21 days).
Primary	Maximum tolerated dose (MTD)	MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.	During the first treatment cycle (21 days).
Primary	The occurrence rate of all adverse events (AEs)	The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)	From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
Primary	The severity of all adverse events (AEs)	The severity of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)	From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
Secondary	Immunogenicity	Incidence of anti-drug antibody (ADA)	Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days). 90 days after the end of the last infusion.
Secondary	Area under the curve (AUC)	The area under the curve (AUC) of serum or plasma concentration of ADC drug, total antibody, and small molecule toxin.	Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days
Secondary	Peak concentration (Cmax)	Maximum observed concentration (Cmax) of ADC drug, total antibody, and small molecule toxin.	Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days
Secondary	Terminal half-life (T1/2)	Terminal plasma half-life is the time required to divide the plasma concentration by two.	Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 day
Secondary	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	Baseline up to 2 years.
Secondary	Disease control rate (DCR)	Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).	Baseline up to 2 years.
Secondary	Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	Baseline to the date of documented disease progression, up to 2 years.
Secondary	Progression-free survival (PFS)	Defined as the time from first documented response to documented disease progression.	Baseline to the date of documented disease progression, up to 2 years.
Secondary	Overall survival(OS)	Overall survival refers to the time from the first treatment to death from any cause.	Baseline to the date of death from any cause, up to 2 years.