Clinical Trial to Evaluate the Tolerance of TQB2210 Injection

NCT06929195 | Completed Phase 1

• 1 other identifier: TQB2210-I-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 7

Brief Summary

TQB2210 injection is a humanized monoclonal antibody against FGFR2b, which can bind to FGFR2b with high specificity and inhibit tumor growth by blocking the signaling pathway mediated by fibroblast growth factor receptor. The aim of this experiment is to evaluate the tolerability, pharmacokinetics, and preliminary efficacy of TQB2210 injection in patients with advanced malignant tumors, and to assess its effectiveness and phase II recommended dose (RP2D) in advanced malignant tumors with FGFR2b overexpression, such as advanced gastric/gastroesophageal junction cancer.

Conditions

Advanced Malignant Tumours

Outcome Measures

Primary Outcomes (4)

• Dose Limiting Toxicity (DLT)

  DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28 days) of treatment.

  During the first cycle. Each cycle is 28 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 cycle. Each cycle is 28 days

• Recommended Phase II Dose

  The recommended dosage for subsequent Phase II studies will be based on MTD (Maximum Tolerant Dose), pharmacokinetics, preliminary efficacy and safety comprehensively determined.

  During the first cycle. Each cycle is 28 days

• Objective Response Rate (ORR) (dose expansion phase)

  Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.

  Up to 2 years

Secondary Outcomes (12)

• Adverse event rate

  Up to 2 years

• Objective Response Rate (ORR) (dose escalation phase)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Progress Free Survival (PFS)

  Up to 2 years

Study Arms (1)

TQB2210 Injection

EXPERIMENTAL

Dose escalation experiment: Intravenous infusion once of TQB2210 for injection every two weeks, 28 days as one treatment cycle. (1.0 mg/kg, 3.0 mg/kg, 8.0 mg/kg, 16.0 mg/kg, 24.0 mg/kg) Dose expansion experiment: Chose one or two appropriate dose groups in the dose escalation experiment to amplify.

Drug: TQB2210 Injection

Interventions

TQB2210 Injection DRUG

TQB2210 injection is a humanized monoclonal antibody against FGFR2b, which can bind to FGFR2b with high specificity. It inhibits tumor growth by blocking the signaling pathway mediated by fibroblast growth factor receptor. Its binding is concentration dependent.

TQB2210 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:

• Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG-PS), score: 0-1; The expected survival time is more than 3 months.
• At least one tumour lesion that can be evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 in the dose-escalation phase and at least one measurable lesion in the dose-expansion phase.
• Good function of major organs.
• Patients with advanced malignant tumours confirmed by histology or cytology, disease progression or intolerance after adequate standard treatment, lack of standard treatment options.
• Can provide tumor tissue specimens collected fresh or sliced within 6 months (preserved in wax blocks collected within 3 years) for further detection for FGFR2b expression
• Fertile subjects should agree that contraception must be used during the study and for 6 months after the end of the study; Women of childbearing age had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating subjects.
• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

You may not qualify if:

• Has had or is currently suffering from other malignant tumors
• There are diseases that affect intravenous injection and venous blood collection
• Adverse reactions from previous treatments have not recovered to CTCAE v5.0 Grade 1
• Received major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose of TQB2210, or exist long-term unhealed wounds or fractures
• Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first dose of TQB2210
• An arterial/venous thrombotic event occurred within 6 months prior to to the first dose of TQB2210
• Patients with active viral hepatitis that is poorly controlled
• Active syphilis patients requiring treatment
• A history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonitis/radiation pneumonia requiring treatment or active pneumonia with obvious clinical symptoms, interstitial pneumonia requiring treatment
• Subjects with any severe and/or uncontrolled illnesses
• Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
• History of hepatic encephalopathy
• Suffering from significant cardiovascular disease
• Active or uncontrolled severe infections
• Patients with renal failure requiring hemodialysis or peritoneal dialysis;

Sponsors & Collaborators

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

Study Sites (7)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

The Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

Changsha, Hunan, 410005, China

Location

Shanghai Tenth Hospital, Tongji University

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, 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: April 8, 2025
• First Posted: April 16, 2025
• Study Start: May 16, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (7)