NCT04144855

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 24, 2019

Last Update Submit

October 29, 2019

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicity (DLT)

    Subjects appear the following toxic reaction relate to the drug after treatment within 28 days ：III °or above of non-hematological toxicity, IV° hematological toxicity , III ° neutropenia associated with fever, III ° thrombocytopenia with bleeding.

    Baseline up to 28 days

Secondary Outcomes (3)

  • Cmax

    0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29.

  • Tmax

    0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29.

  • AUC0-t

    0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29.

Study Arms (1)

TQB3474 injection

EXPERIMENTAL

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

Drug: TQB3474 injection

Interventions

TQB3474 injectionDRUG

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

TQB3474 injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and 70 years old.
  • \. Histologically or cytologically confirmed advanced solid tumors.
  • \. Has the surgery more than 4 weeks before the first dose.
  • \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • \. Life expectancy ≥12 weeks.
  • \. Adequate organ system function.
  • \. 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.
  • \. Understood and signed an informed consent form.

You may not qualify if:

  • Has received chemotherapy or radiotherapy within 4 weeks before the first dose.
  • Hypersensitivity to TQB3474 or its excipient.
  • Has factors that impact on intravenous infusion of drugs and venous blood collection.
  • Has severe gastrointestinal disease within 4 weeks before the first dose.
  • Has severe eye disease.
  • Breastfeeding or pregnant women.
  • Has brain metastases.
  • HCV antibody and HCV-RNA positive; Syphilis positive; HBsAg positive and HBV DNA positive (≥1000 copies /mL).
  • Has infection that need systemic treatment during screening.
  • Has participated in any other clinical trial within 4 weeks before the first dose.
  • According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

NOT YET RECRUITING

Guizhou Cancer Hospital

Guiyang, Guizhou, 550008, China

NOT YET RECRUITING

Yongsheng

Chengdu, Sichuan, 610000, China

RECRUITING

Central Study Contacts

Yongsheng Wang, Doctor

CONTACT

028-85422707licdzk@163.com

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

October 24, 2019

First Posted

October 30, 2019

Study Start

November 27, 2018

Primary Completion

November 27, 2020

Study Completion

May 30, 2021

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations

CN(3)