A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection

NCT ID: NCT04144855

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2021-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB3474 injection

Participants receive TQB3474 injection by intravenous (IV) infusion on Day 1, 8, 15, 22 of each 28 day cycle.

Group Type EXPERIMENTAL

TQB3474 injection

Intervention Type DRUG

This is a kind of heat shock protein (HSP90) inhibitor.

Interventions

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TQB3474 injection

This is a kind of heat shock protein (HSP90) inhibitor.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1.18 and 70 years old.

2\. Histologically or cytologically confirmed advanced solid tumors.

3\. Has the surgery more than 4 weeks before the first dose.

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

5\. Life expectancy ≥12 weeks.

6\. Adequate organ system function.

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

8\. Understood and signed an informed consent form.

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 DNA positive (≥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 subjects are not suitable for the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Site Status NOT_YET_RECRUITING

Yongsheng

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongsheng Wang, Doctor

Role: CONTACT

028-85422707

Facility Contacts

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Weiqi Nian, Doctor

Role: primary

023-65079277

Weiwei Ouyang, Doctor

Role: primary

0851-86523929

Yongsheng Wang, Doctor

Role: primary

028-85422707

Other Identifiers

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TQB3474-I-01

Identifier Type: -

Identifier Source: org_study_id

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