Clinical Trial of TQB3002 in Patients With Advanced Cancers

NCT06662760
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
150
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Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Start date
2024-12-09
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Number of sites
11
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Summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers
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Short title
Clinical Trial of TQB3002 in Patients With Advanced Cancers
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Official title
A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-10-01
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First posted
2024-10-29
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Registry last updated
2025-11-25
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Primary completion date
2025-11-01
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Start date
2024-12-09
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Participants
150
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Participant count basis
Estimated
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Planned participants
150
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Protocol amendments
4
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Number of sites
11
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Registry sponsor category
Industry
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Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06662760
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ClinicalTrials.gov ID
NCT06662760
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose Limiting Toxicity (DLT)

    Timeframe: During the first 28 days

    DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28days) of treatment.

  2. Maximum tolerated dose (MTD)

    Timeframe: During the first 28 days

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

  1. Half-life (T1/2)

    Timeframe: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    Terminal half-life (T1/2)

  2. The area under the curve (AUC)

    Timeframe: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    The area under the curve (AUC) of serum concentration of TQB3002

  3. Apparent Plasma Clearance (CL)

    Timeframe: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    Apparent plasma clearance of TQB3002

  4. Apparent volume of distribution (Vz)

    Timeframe: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    The ratio of the amount of TQB3002 in the body to the blood concentration

  5. Minimum concentration (Cmin)

    Timeframe: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    Minimum observed concentration (Cmin) of TQB3002

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
  • Age: ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
  • Histologically or cytologically diagnosed with advanced cancers
  • Subjects with advanced malignancies who have failed standard therapy or lack effective treatment
  • Major organs are functioning well；
  • Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

  • Current concomitant presence of other malignancies within 5 years prior to the first dose；
  • Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy
  • Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose
  • Long-term unhealed wounds or fractures
  • Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose
  • Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy
  • A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder
  • Subjects with any severe and/or uncontrolled disease
Sources for eligibility
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  • Guangdong Provincial People's HospitalGuangzhou, ChinaRecruiting
  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen CenterShenzhen, ChinaNot yet recruiting
  • Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
  • Jiangsu Province HospitalNanjing, ChinaNot yet recruiting
  • The First Affiliated Hospital Of Nanchang UniversityNanchang, ChinaNot yet recruiting
  • Shanghai Pulmonary HospitalShanghai, ChinaNot yet recruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaNot yet recruiting
  • The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaNot yet recruiting
  • Sichuan Cancer HospitalChengdu, ChinaNot yet recruiting
  • Mianyang Central HospitalMianyang, ChinaNot yet recruiting
  • Yunnan Cancer HospitalKunming, ChinaNot yet recruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)