Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

NCT05735496 | Active Not Recruiting Phase 1

• 1 other identifier: TQB2102-I-01
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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.

• Dose escalation: recommended phase 2 dose (RP2D)

  The RP2D of DT-9081 is determined using pharmacokinetics, pharmacodynamics and safety data of the dose escalation part of the study.

  Up to 2 years

Secondary Outcomes (9)

• Immunogenicity

  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.

• Area under the curve (AUC)

  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

• Peak concentration (Cmax)

  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

• Terminal half-life (T1/2)

  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

• Objective Response Rate (ORR)

  Baseline up to 2 years.

Study Arms (1)

TQB2102 injection

EXPERIMENTAL

intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg)

Drug: TQB2102 injection

Interventions

TQB2102 injection DRUG

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

TQB2102 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 tumo;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (12)

Fujian Cancer Hospital.

Fuzhou, Fujian, 350000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Harbin Medical University Cancer Hospital, Harbin, China

Harbin, Heilongjiang, 150000, China

Location

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 11000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Fudan University shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Shanghai, Shanghai Municipality, 200092, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: March 9, 2023
• Primary Completion: July 21, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)