NCT05198505

Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2868 Injection in Subjects With Advanced Malignant Tumors

Status unknown Phase 1 Last updated 29 April 2022

What this trial tests

Phase 1 trial testing TQB2868 Injection in Advanced Malignant Tumor in 280 participants. Status unknown.

Timeline

27 April 2022

Primary endpoint
1 June 2023

1 June 2024

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	280
Start date	27 April 2022
Primary completion	1 June 2023
Estimated completion	1 June 2024
Sites	3 locations across China

Drugs / interventions tested

• TQB2868 Injection — full drug profile →

Conditions studied

• Advanced Malignant Tumor — all drugs for Advanced Malignant Tumor →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Malignant Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Dose-limiting toxicity (DLT)
  Time frame: up to 10 months
  DLT definition: the subject has the following adverse events related to the test drug within one treatment cycle (21 days) after the first administration. 1. Grade ≥ 3 neutropenia with fever; Grade 4 neutropenia that cannot be recovered within 3 days after symptomatic treatment; Grade 3 anemia that cannot be recovered within 14 days; ≥ Grade 3 thrombocytopenia with bleeding; Other hematologic
• Recommended Phase II Dose (RP2D)
  Time frame: up to 10 months
  To evaluate RP2D of TQB2868 injection in adult patients with advanced malignant tumors
• Maximum Tolerated Dose (MTD)
  Time frame: up to 10 months
  Defined as the highest dose when dose-limiting toxicity (DLT) occurred in less than 33% of subjects.
• All adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)
  Time frame: up to 17 months
  ncidence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

Sponsor's own description

The TQB2868 protein in this study targeted programmed cell death protein 1 (PD-1) and transforming growth factor-β (TGF-β). The bifunctional fusion protein targets and neutralizes TGF-β in the tumor microenvironment. On the basis of inhibiting PD-1 / programmed death ligand 1 (PD-L1) pathway, T cells can restore activity, enhance immune response, and more effectively improve the effect of inhibiting tumor occurrence and development.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting transforming growth factor beta signaling in metastatic osteosarcoma.
   Ge R, Huang GM. · · 2023 · cited 25× · PMID 38021074 · DOI 10.1016/j.jbo.2023.100513
2. Unraveling the Role of the Tumor Extracellular Matrix to Inform Nanoparticle Design for Nanomedicine.
   Cassani M, Fernandes S, Pagliari S, Cavalieri F, et al · · 2025 · cited 24× · PMID 39629891 · DOI 10.1002/advs.202409898
3. Cancer-associated fibroblasts in cancer drug resistance and cancer progression: a review.
   Masuda H. · · 2025 · cited 11× · PMID 40707476 · DOI 10.1038/s41420-025-02566-x
4. Bidirectional crosstalk between the epithelial-mesenchymal transition and immunotherapy: A bibliometric study.
   Du W, Tang Z, Du A, Yang Q, et al · · 2024 · cited 4× · PMID 38502119 · DOI 10.1080/21645515.2024.2328403
5. Strategies to target PD-1/PD-L1 in the tumor microenvironment.
   Kui Y, Tong F, Zhang R, Dong X, et al · · 2026 · PMID 41784760 · DOI 10.1007/s13402-026-01181-x