A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection

Last updated: October 29, 2019
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04144855
TQB3474-I-01
  • Ages 18-70
  • All Genders

Study Summary

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3474 in patients with advanced malignant tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1.18 and 70 years old.

  1. Histologically or cytologically confirmed advanced solid tumors.

  2. Has the surgery more than 4 weeks before the first dose.

  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

  4. Life expectancy ≥12 weeks.

  5. Adequate organ system function.

  6. Male or female subjects should agree to use an adequate method of contraception startingwith the first dose of study therapy through 6 months after the last dose of study.

  7. Understood and signed an informed consent form.

Exclusion

Exclusion Criteria:

  1. Has received chemotherapy or radiotherapy within 4 weeks before the first dose.

  2. Hypersensitivity to TQB3474 or its excipient.

  3. Has factors that impact on intravenous infusion of drugs and venous blood collection.

  4. Has severe gastrointestinal disease within 4 weeks before the first dose.

  5. Has severe eye disease.

  6. Breastfeeding or pregnant women.

  7. Has brain metastases.

  8. HCV antibody and HCV-RNA positive; Syphilis positive; HBsAg positive and HBV DNApositive (≥1000 copies /mL).

  9. Has infection that need systemic treatment during screening.

  10. Has participated in any other clinical trial within 4 weeks before the first dose.

  11. According to the judgement of the researchers, there are other factors that subjectsare not suitable for the study.

Study Design

Total Participants: 40
Study Start date:
November 27, 2018
Estimated Completion Date:
May 30, 2021

Connect with a study center

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400000
    China

    Site Not Available

  • Guizhou Cancer Hospital

    Guiyang, Guizhou 550008
    China

    Site Not Available

  • Yongsheng

    Chendu, Sichuan 610000
    China

    Active - Recruiting

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