To Evaluate the Tolerability and Pharmacokinetics of TQB2101 for Injection in Patients With Advanced Malignant Tumors

NCT06948539 | Not Yet Recruiting Phase 1

• 1 other identifier: TQB2101-I-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the tolerability and pharmacokinetics of TQB2101 for injection in subjects with advanced malignant tumors.

Conditions

Breast Cancer; Lung Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Phase II recommended doses (RP2D)

  The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).

  Baseline up to 24 months

• Dose-limiting toxicity (DLT)

  Adverse events that meet the protocol definition of dose-limiting toxic event timing were evaluated according to the Common Terminology Criteria for Adverse Events 5.0.

  Up to 1 month

• Maximum tolerated dose (MTD)

  The previous dose of the dose group in which dose-limiting toxicity occurs is the maximum tolerated dose.

  Up to 1 month

Secondary Outcomes (5)

• Incidence and severity of adverse event (AE) and serious adverse event (SAE), and abnormal laboratory test indicators

  Up to 24 months

• Peak time

  Up to 4 months

• Peak concentration Cmax

  Up to 4 months

• Plasma elimination half-life t1/2

  Up to 4 months

• Objective response rate

  Up to 24 months

Study Arms (1)

TQB2101 injection

EXPERIMENTAL

The drug was administered every 3 weeks for 21 consecutive days in a treatment cycle.

Drug: TQB2101 for injection

Interventions

TQB2101 for injection DRUG

TQB2101 for injection is a receptor tyrosine kinase-like orphan receptor-1 antibody drug conjugate.

TQB2101 injection

Eligibility Criteria

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

You may qualify if:

• The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
• years old ≤ age ≤75 years old (calculated on the date of signing the informed consent);
• Eastern Cooperative Oncology Group (ECOG) score 0\~1;
• Expected survival greater than 12 weeks;
• Patients with advanced solid tumors confirmed by cytology/histopathology, failure of standard treatment or lack of effective treatment ; Participants with Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) -positive advanced solid tumors were enrolled in the extended study phase.
• Evidence of at least one measurable lesion according to RECIST 1.1 criteria, except that the dose-escalation phase is not required to be measurable, as long as it meets the assessment of disease status.
• The main organs function well and meet the following criteria:
• Hemoglobin (HGB) ≥80g/L;
• Absolute neutrophil count (ANC) of solid tumor subjects ≥1.5×109 /L;
• Platelet count (PLT) ≥100×109/L, if accompanied by bone marrow invasion, platelet ≥75×109/L;
• Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN);
• Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN. ALT and AST≤5×ULN if accompanied by liver metastasis;
• Serum creatinine (CR) ≤1.5×ULN or creatinine clearance (CCR) ≥60 mL /min (standard Cockcroft-Gault formula was applied;
• Prothrombin time (PT), activated partial thromboplastin time (APTT), International standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);
• Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.

You may not qualify if:

• Had or was currently suffering from other malignant tumors within 3 years prior to the first medication.
• There are multiple factors that affect intravenous injection, venous blood collection diseases, or have an impact on oral drugs.
• The adverse reactions of previous treatment failed to recover to Common Terminology Criteria for Adverse Events Version 5 (CTCAEv5.0) score ≤1.
• Patients who had major surgical treatment, significant traumatic injury, or potential major surgery during the expected study treatment period within 4 weeks prior to initial medication, or who had long-term unhealed wounds or fractures.
• Subjects who have had any bleeding event ≥CTCAEv5.0 level 3 within 4 weeks prior to initial dosing, or who have bleeding or clotting disease and are taking warfarin, aspirin, or other antiplatelet agglutinating agents (except maintenance doses) : Subjects with aspirin ≤100mg/ day, clopidogrel ≤75mg/ day, or with any signs of bleeding or medical history determined by the investigator to be unsuitable for enrollment.
• Patients who experienced a hyperarterial/venous thrombosis event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before the first administration of the drug.
• Chronic hepatitis B active or active hepatitis C subjects. Subjects who are positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies during screening should undergo Hepatitis B Virus (HBV) DNA titer testing or HCV RNA testing.
• Patients with active syphilis who need treatment.
• There is a history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or active pneumonia with clinical symptoms.
• Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
• Decompensated stage of cirrhosis and history of hepatic encephalopathy.
• Subjects with clinically significant cardiovascular disease, including any of the following:
• Participants who had acute myocardial infarction and severe/unstable angina pectoris within 6 months before the start of study treatment; Or have heart failure of the New York Heart Association's heart function classification level 2 or higher;
• QT interval prolongation at rest as corrected by Fridericia Formula (QTcF), QTc interval ≥450ms(male), QTc interval ≥470 ms(female);
• Have a past or ongoing history of severe uncontrolled ventricular arrhythmias requiring medical treatment;

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Prevention Center

Guanzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Rui Hua Xu, Doctor

CONTACT

+86 17600401750; xurh@sysucc.org.cn

Feng Wang, Doctor

CONTACT

+86 18191965905; wangfeng@sysucc.org.cn

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 17, 2025
• First Posted: April 29, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2024-12

Locations

CN (1)