Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors

NCT05154630 | Terminated Phase 1

• 1 other identifier: TQB2858-I-05
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief Summary

This study is divided into two phases: dose escalation and cohort expansion. The dose escalation stage aims to evaluate the tolerability, pharmacokinetic characteristics and safety of TQB2858 injection in subjects with advanced malignant tumors. The cohort expansion phase aims to evaluate the initial efficacy and safety of TQB2858 injection in patients with soft tissue sarcoma, and to explore treatment-related biomarkers.

Conditions

Advanced Cancer; Advanced Soft-tissue Sarcoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.

  Baseline up to 48 weeks

• Overall response rate (ORR)

  ORR refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or iRECIST (CR and PR under iRECIST criteria can occur after imaging disease progression).

  up to 48 weeks

Secondary Outcomes (4)

• Disease control rate（DCR）

  up to 48 weeks

• Overall survival (OS)

  Baseline up to die

• Progression-Free Survival (PFS)

  up to 48 weeks

• Duration of Response (DOR)

  up to 48 weeks

Study Arms (1)

TQB2858 injection

EXPERIMENTAL

Participants will receive 3 mg/60 mg/600 mg/1200 mg/1800 mg single dose of TQB2858 injection on Day 1, iv (injection of vein), once every three weeks.

Drug: TQB2858 injection

Interventions

TQB2858 injection DRUG

TQB2858 is a Programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody.

TQB2858 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I (dose-escalation phase).
• a) Patients with advanced malignant solid/hematologic tumors who have a histologically and/or cytologically confirmed diagnosis and who have failed standard therapy or lack effective therapies.
• Phase II (cohort expansion phase).
• Unresectable, recurrent or metastatic adenoid soft tissue sarcoma diagnosed by histology.
• Previously received anti-vascular targeted drug therapy
• Have at least one measurable lesion Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• Age: 18 to 70 years old;
• The Eastern Cooperative Oncology Group (ECOG) score: 0 to 1;
• The expected survival period is ≥3 months;
• Normal function of major organs
• Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; men should agree to use effective contraception during the study period and after the end of the study period 6 Effective contraceptive measures must be used within one month.
• Patients voluntarily enroll in this study, sign an informed consent form and comply well.

You may not qualify if:

• Combined diseases and medical history:
• Have presented with or currently have concurrent other malignancies within 2 years.
• Unresolved toxic reactions due to any prior treatment above Common Terminology Criteria for Adverse Events(CTCAE) grade 1, excluding alopecia, peripheral sensory nerve disorders.
• Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment.
• Long-term untreated wounds or fractures.
• An arterial/venous thrombotic event within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism.
• Persons with a history of psychotropic substance abuse who are unable to abstain or have a mental disorder.
• Subjects with any severe and/or uncontrollable disease, including:
• Tumor-related symptoms and treatment:
• Have received surgery, chemotherapy, radiotherapy or other anti-cancer therapy within 4 weeks prior to the start of study treatment.
• Treatment with proprietary Chinese medicines with clear antitumor indications in the National Medical Products Administration (NMPA)-approved drug formulary within 2 weeks prior to the start of study treatment.
• Prior receipt of immune dual anti-treatment drugs against the same target of TQB2858 injection.
• Uncontrolled pleural effusions, pericardial effusions, or ascites that still require repeated drainage (in the judgment of the investigator);
• Brain metastases with less than 4 weeks of stable symptom control after discontinuation of dehydrating agents and steroids.
• Research and treatment related:

Sponsors & Collaborators

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

Study Sites (5)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100000, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, 610000, China

Location

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: December 9, 2021
• First Posted: December 13, 2021
• Study Start: January 14, 2022
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: January 18, 2024

Record last verified: 2023-12

Locations

CN (5)