A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies

NCT07113925 | Recruiting Phase 1

• 1 other identifier: TQB2101-I-02
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief Summary

TQB2101 for Injection is an Antibody-Drug Conjugate (ADC) targeting Receptor Tyrosine Kinase Like Orphan Receptor 1 (ROR1).It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.

Conditions

Advanced Hematologic Malignancies

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity

  Dose-limiting toxicity (DLT) refers to any Grade 3-5 adverse event (as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0) considered related to the investigational drug and occurring from the first dose administration through the end of the first treatment cycle.

  Up to 24 months

• Maximum Tolerated Dose

  Defined as the highest dose in less than 33% of subjects with dose-limiting toxicity (DLT).

  Up to 24 months

• Phase II recommended dose

  The recommended dose for subsequent phase II studies will be determined based on Maximum Tolerated Dose, Pharmacokinetics, preliminary efficacy and safety.

  Up to 24 months

Secondary Outcomes (11)

• Overall Response Rate (ORR)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

• Progression-Free Survival (PFS)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

• Incidence and severity of adverse events (AEs)

  Up to 24 months

Study Arms (1)

TQB2101 for Injection

EXPERIMENTAL

Intravenous injection, administered starting on Day 1 of each cycle, with a treatment cycle every 3 weeks; the dose levels range from 0.4 mg/kg to 1.6 mg/kg.

Drug: TQB2101 for Injection

Interventions

TQB2101 for Injection DRUG

TQB2101 for Injection is an ROR1 ADC, an antibody-drug conjugate. It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.

TQB2101 for 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:

• Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.
• Age between 18 and 75 years (calculated based on the date of signing the informed consent form).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival \>12 weeks.
• Subjects with advanced hematologic malignancies confirmed by cytology/histopathology, who have failed standard treatment or lack effective treatment options.
• At least one measurable lesion according to the 2014 Lugano criteria: lymph node lesions with long axis \>15mm or extranodal lesions with long axis \>10mm on CT cross-sectional imaging.
• Adequate organ function meeting the following criteria:
• Hemoglobin (HGB) ≥80g/L
• Absolute neutrophil count (ANC) ≥1.0×10⁹/L
• Platelet count (PLT) ≥75×10⁹/L (≥50×10⁹/L if with bone marrow involvement)
• Total bilirubin (TBIL) ≤1.5×ULN
• Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5×ULN if with liver metastases)
• Serum creatinine (CR) ≤1.5×ULN OR creatinine clearance rate (CCR) ≥60ml/min (calculated using standard Cockcroft-Gault formula)
• Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR) ≤1.5×ULN (without anticoagulation therapy)
• Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with negative blood pregnancy test within 7 days prior to enrollment; male subjects must agree to use effective contraception during the study and for 6 months after study completion.

You may not qualify if:

• Tumor-related symptoms and treatments:
• Lymphoma involving or suspected to involve the central nervous system, or primary central nervous system lymphoma;
• Patients who have received chemotherapy, immunotherapy within 4 weeks before the first administration, radiotherapy or small molecule targeted drugs within 2 weeks, or are still within 5 half-lives of the drug (whichever occurs earlier), with a washout period calculated from the end of the last treatment;
• Patients who have received treatment with traditional Chinese medicine with clear anti-tumor indications in the National Medical Products Administration (NMPA) approved drug instructions (including Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea javanica Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.) within 2 weeks before the first administration;
• Patients who have previously received treatment with ROR1 inhibitor drugs;
• Patients who have participated in other anti-tumor drug clinical trials within 4 weeks before the first administration (calculated from the last use of the trial drug) and have used the trial drug, or are still within 5 half-lives of the study drug (whichever is shorter).
• Patients with adverse reactions from previous treatments that have not recovered to a Common Terminology Criteria for Adverse Events Version 5.0 (CTC AE v5.0) grade score of ≤1, except for alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which are judged by the investigator to have no safety risks.
• Patients who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period (except for surgeries specified in the protocol) within 4 weeks before the first administration, or have long-term unhealed wounds or fractures.
• Patients who have experienced arterial or venous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
• Patients with decompensated liver cirrhosis (Child-Pugh liver function rating of B or C), active chronic hepatitis B, or active hepatitis C: HbsAg positive and hepatitis B virus (HBV) DNA positive or with a detection value exceeding the lower limit of detection; HCV antibody positive and HCV RNA positive or with a detection value exceeding the lower limit of detection.
• Note: For eligible HbsAg positive patients with hepatitis B, regardless of whether HBV DNA is detectable, continuous antiviral treatment (recommended nucleotide analogues) and regular monitoring of HBV DNA are required; for patients with positive HBcAb but negative HbsAg, regular monitoring of HBV DNA is required, and preventive antiviral treatment is recommended; for patients with hepatitis C, regular monitoring of hepatitis C virus (HCV) RNA is required.
• Patients with active syphilis requiring treatment.
• Patients with active pulmonary tuberculosis, a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms. (10) Subjects with a history of substance abuse of psychotropic drugs and unable to quit or with mental disorders.
• Subjects with a history of decompensated liver cirrhosis and hepatic encephalopathy.
• Subjects with clinically significant cardiovascular diseases, including any of the following conditions:

Sponsors & Collaborators

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

Study Sites (3)

The Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Peng Liu, Doctor

CONTACT

18222106302; liupeng@zs-hospital.sh.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: July 31, 2025
• First Posted: August 11, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-04

Locations

CN (3)