A Clinical Trial of TQB6426 for Injection in Patients With Advanced Solid Tumors

NCT07730190 | Recruiting Phase 1

• 1 other identifier: TQB6426-I-01
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 8

Brief Summary

TQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (5)

• Dose-Limiting Toxicity (DLT)

  Study participants experienced protocol-specified adverse events related to the investigational drug within one cycle (21 days) of receiving the investigational drug.

  Baseline to 21 days

• Maximum Tolerated Dose

  The highest dose at which less than 33% of study participants experience dose-limiting toxicity (DLT)

  Baseline to the end of the first treatment cycle (each cycle is 21 days）

• Recommended Phase II Dose

  The dose level of TQB6426 recommended for the further clinical trail studies based on assessment of the safety, efficacy and PK data from this study.

  Baseline to study completion (up to 24 months).

• Incidence and severity of adverse events (AEs)

  Incidence and severity of adverse events (AEs)

  up to 24 months

• Maximum Administered Dose

  MAD is defined to be reached if, following the pre-specified dose escalation, a dose-exposure plateau is achieved as judged by PK data, or further dose escalation carries substantial safety risks or subjects cannot tolerate continued dose increase based on available safety data, or model analysis indicates that the optimal safe and effective target dose has been explored.

  Baseline to the end of the first treatment cycle (each cycle is 21 days）

Secondary Outcomes (15)

• Maximum Concentration (Cmax)

  up to 24 months

• Area under the plasma drug concentration-time curve from time zero to the time of the last accurately quantifiable concentration (AUC0-t)

  up to 24 months

• Area under the plasma concentration-time curve extrapolated from time zero to infinite time（AUC0-∞）

  up to 24 months

• Time to peak concentration (Tmax)

  up to 24 months

• Terminal Elimination Rate Constant（λz）

  up to 24 months

Study Arms (1)

TQB6426 Dose Escalation and Expansion

EXPERIMENTAL

This arm includes two phases: Dose Escalation Phase (Phase Ia): Treatment regimen is TQB6426 for Injection via intravenous infusion (IV) on Day 1, every 3 weeks (Q3W). An accelerated titration design combined with a "Rolling 6" dose-escalation approach was adopted. Dose Expansion Phase (Phase Ib): The study dose will be finalized according to the results from Phase Ia, administered intravenously on Day 1 every 3 weeks (Q3W).

Drug: TQB6426 for Injection

Interventions

TQB6426 for Injection DRUG

TQB6426 is a glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Preclinical studies have demonstrated its potent anti-tumor activity coupled with a favorable therapeutic safety window, which provides sufficient pharmacological and toxicological evidence to support the initiation of human clinical trials.

TQB6426 Dose Escalation and Expansion

Eligibility Criteria

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

You may qualify if:

• Study participants voluntarily enroll in this study, sign the informed consent form, and demonstrate good treatment compliance.
• Age ranging from 18 to 75 years (calculated based on the date of informed consent signature).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Estimated survival time exceeding 12 weeks.
• Child-Pugh liver function score ≤ 7 points (Class B).
• Per RECIST v1.1 criteria, at least one evaluable tumor lesion must be identified as a target lesion. Lesions previously treated with local therapy (transarterial embolization, transarterial chemoembolization, transarterial radioembolization, surgery, radiofrequency ablation, microwave ablation, other thermal ablation, percutaneous ethanol injection, radiotherapy, etc.) may also serve as target lesions provided there is documented progression in such lesions.
• Participants must provide qualified tumor tissue specimens, or consent to submit archived tumor tissue samples, or undergo percutaneous core biopsy or surgical biopsy on previously unirradiated tumor lesions to supply specimens for central laboratory biomarker testing.
• Dose-escalation phase: Advanced solid tumors confirmed via histopathological or cytological examination with failure of prior standard systemic anti-tumor therapies.
• Dose-expansion phase: Glypican-3 (GPC3) positivity confirmed by immunohistochemistry (IHC); prior IHC test reports are acceptable.
• Hematology laboratory criteria (no blood transfusion/blood products or hematopoietic stimulating factor administration within 14 days prior to screening): Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
• Serum biochemistry laboratory criteria: 1) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); for patients with intrahepatic metastases, ALT and AST ≤ 5 × ULN; 2) Total Bilirubin (TBIL) ≤ 3 × ULN (≤ 3 × ULN allowed for patients with Gilbert's syndrome); 3) Serum albumin ≥ 28 g/L; 4) Serum Creatinine (Cr) ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL/min calculated via the Cockcroft-Gault formula.
• Urinalysis criteria: Urine protein \< 2+ on routine urinalysis; if urine protein ≥ 2+, 24-hour urinary protein quantification must be confirmed ≤ 1.0 g.
• Coagulation function criteria: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR) ≤ 1.5 × ULN (for patients without prior anticoagulant therapy).
• Thyroid function criteria: Thyroid-Stimulating Hormone (TSH) ≤ ULN; participants with abnormal TSH but normal free T3 and free T4 levels are eligible for enrollment.
• Women of childbearing potential must agree to use effective contraception throughout the study and for 6 months after study completion, and have a negative serum pregnancy test within 7 days prior to enrollment. Male participants must agree to use effective contraception throughout the study and for 6 months following study completion.

You may not qualify if:

• Diagnosis of another malignant tumor within 5 years prior to the first study dose, or concurrent secondary malignancy at screening. Eligible exceptions are as follows: other malignancies cured by single surgical resection with a continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, papillary thyroid carcinoma, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive carcinoma), Tis (carcinoma in situ), T1 (tumor invading lamina propria)\].
• Medical conditions interfering with intravenous injection or venous blood collection (including but not limited to active phlebitis, severe lymphedema, extensive cutaneous infection, etc.).
• Unresolved adverse toxicities higher than NCI CTCAE Grade 1 stemming from prior therapies, excluding alopecia, skin pigmentation, and toxicities deemed by the Investigator to carry no safety risks.
• Major surgical procedures, significant traumatic injuries within 4 weeks before the first dose, or persistent unhealed wounds/fractures.
• Any hemorrhagic event ≥ NCI CTCAE Grade 3 occurring within 4 weeks prior to the first administration of study drug.
• History of arterial or venous thromboembolic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism. (Note: Thrombosis related to implantable venous access ports, catheter-induced thrombosis, or superficial venous thrombosis shall not be categorized as "severe" thromboembolism.)
• Participants with active viral hepatitis and poor disease control are excluded. Participants meeting the following criteria may be screened: HBsAg-positive participants must have a quantitative HBV DNA level \<2000 IU/mL (or 10000 copies/mL), and participants shall receive anti-HBV therapy throughout the entire study period. Participants with HCV infection requiring treatment may receive approved antiviral therapy during the study.
• Imaging confirmation of inferior vena cava tumor thrombus, complete occlusion of the main portal vein (tumor thrombus or blood thrombus), concurrent tumor thrombus invasion of the main portal vein plus primary branches, or portal vein tumor thrombus extending into the superior mesenteric vein, splenic vein or more proximal vessels.
• Peptic ulcer disease or inflammatory bowel disease.
• Active syphilis infection requiring clinical treatment.
• Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis/radiation pneumonitis requiring treatment, symptomatic active pneumonia; prior interstitial lung disease (ILD) that required intervention or current ILD.
• History of untreatable psychoactive substance abuse or diagnosed psychiatric disorders.
• Candidates scheduled for allogeneic bone marrow transplantation or solid organ transplantation, or those who have received such transplantations previously.
• Documented history of hepatic encephalopathy.
• Subjects with any severe and/or uncontrolled underlying diseases, including:

Sponsors & Collaborators

• Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (8)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

NOT YET RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Qiang Xia, Doctor

CONTACT

13661889035; Xiaqiang@medmail.com.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 22, 2026
• First Posted: July 28, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

CN (8)