Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancies
Overview
- Phase
- Phase 1
- Intervention
- TQB2858 injection
- Conditions
- Advanced Cancer
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 8
- Locations
- 5
- Primary Endpoint
- Overall response rate (ORR)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
TQB2858 injection
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.
Intervention: TQB2858 injection
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: up to 48 weeks
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).
Maximum tolerated dose (MTD)
Time Frame: Baseline up to 48 weeks
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.
Secondary Outcomes
- Progression-Free Survival (PFS)(up to 48 weeks)
- Duration of Response (DOR)(up to 48 weeks)
- Disease control rate（DCR）(up to 48 weeks)
- Overall survival (OS)(Baseline up to die)