TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers

NCT05894421 | Recruiting Phase 1

• 1 other identifier: TQB2223-I-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 11

Brief Summary

TQB2223 is a recombinant, fully humanized antibody that binds lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and effectiveness of TQB2223 injection in combination with Penpulimab in subjects with advanced cancers.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicity (DLT)

  DLT is defined as toxicities that meet pre-defined severity criteria of Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and assessed as having a suspected relationship to TQB2223 injection, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (21 days) of treatment.

  During the first treatment cycle (21 days).

• Maximum tolerated dose (MTD)

  MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

  During the first treatment cycle (21 days).

• Objective Response Rate (ORR)

  Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria and Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST) for solid tumors, Lugano 2014 criteria and Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) for lymphoma.

  From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.

Secondary Outcomes (12)

• Percentage of anti-drug antibody (ADA) positive patients

  Pre-dose on Cycle 1, 2, 4, 8 . 30 days and 90 days after the last dose. Each cycle is 21 days.

• The area under the curve (AUC)

  5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.

• Peak concentration (Cmax)

  5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.

• Terminal half-life (T1/2)

  5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.

• Receptor occupation (RO)

  5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days.

Study Arms (1)

TQB2223 injection+ Penpulimab Injection

EXPERIMENTAL

intravenous injection of TQB2223 injection and Penpulimab injection for one times every three weeks, 21 days as a treatment cycle.

Drug: TQB2223 injection+ Penpulimab Injection

Interventions

TQB2223 injection+ Penpulimab Injection DRUG

TQB2223 is an anti lymphocyte activation gene-3 (LAG-3) antibody. Penpulimab Injection is an anti-PD-1 antibody.

TQB2223 injection+ Penpulimab 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, 410006, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

The second hospital of Dalian medical university

Dalian, Liaoning, 116027, China

NOT YET RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

RECRUITING

Central Study Contacts

Li Zhang, Doctor

CONTACT

86-020-87343458; zhangli@sysucc.org.cn

Qingqing Cai, Doctor

CONTACT

+86 13798101121; caiqq@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: May 31, 2023
• First Posted: June 8, 2023
• Study Start: June 6, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)