Combining TQB2223 and Penpulimab for advanced cancer treatment

Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2223 Injection Combined With Penpulimab Injection in Subjects With Advanced Cancers

This study is testing a new combination of two cancer treatments, TQB2223 and Penpulimab, to see if they can help people with advanced cancer feel better and improve their immune response.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Penpulimab
• Locations: 11 sites (Fuzhou, Fujian and 10 other locations)
• Trial ID: NCT05894421 on ClinicalTrials.gov

What this trial studies

This phase 1 study evaluates the safety, tolerability, pharmacokinetics, and effectiveness of TQB2223, a humanized antibody targeting LAG-3, in combination with Penpulimab for patients with advanced cancers. The study aims to enhance T-cell proliferation and cytokine production by blocking the LAG-3/MHC-II interaction. Participants will be closely monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced malignancies that have not responded to standard therapies.

Not a fit: Patients with concurrent secondary malignancies or those with uncontrolled intercurrent illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers who have exhausted standard treatment options.

How similar studies have performed: Other studies targeting LAG-3 have shown promise, indicating potential for success with this novel combination approach.

Eligibility criteria

Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥3 months;
* Histologically or cytologically confirmed malignancies;
* Subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment;
* Patient has at least one evaluable lesion assessed by RECIST 1.1;
* The main organs function is well;
* Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures during study period until at least 6 months after the last dose of study drug.

Exclusion Criteria:

* Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;
* History of uncontrolled intercurrent illness;
* Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
* Prior treatment targeting LAG-3;
* Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

Where this trial is running

Fuzhou, Fujian and 10 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Cancer Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China (Recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
• The second hospital of Dalian medical university — Dalian, Liaoning, China (Not_yet_recruiting)
• Tongji Hospital of Tongji University — Shanghai, Shanghai, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Li Zhang, Doctor

Conditions Advanced Cancer