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NCT03654547 · ClinicalTrials.gov registry record · Phase 1

Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

A Phase 1 study of Advanced Solid Tumors and Triple Negative Breast Cancer, sponsored by TransThera Sciences (Nanjing).

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
2
Study locations

NCT03654547 is a Phase 1 study of Advanced Solid Tumors and Triple Negative Breast Cancer that has completed, run by TransThera Sciences (Nanjing). The registered enrollment target is 48 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03654547, a Phase 1 study of Advanced Solid Tumors and Triple Negative Breast Cancer, has completed, sponsored by TransThera Sciences (Nanjing).

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target
2
Study locations

Study Summary

This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study consists of a dose escalation part followed by a MTD expansion part.

Conditions Studied

Advanced Solid Tumors Triple Negative Breast Cancer

Interventions

  • DRUG TT-00420

Study Locations (2)

Texas

  • MD Anderson Cancer Center - Houston

Beijing Municipality

  • Cancer Hopital Chinese Academy of Medical Sciences - Beijing

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2019-01-08
Est. Completion 2024-02-28
Phase Phase 1

Sponsor

TransThera Sciences (Nanjing)

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03654547

The ClinicalTrials.gov registry entry for NCT03654547 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (76% lower). The listed sponsor is TransThera Sciences (Nanjing), which has 7 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which TT-00420 is the first listed.

NCT03654547 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Texas, Beijing Municipality.

Frequently Asked Questions

What is clinical trial NCT03654547 about?

NCT03654547 is a clinical study titled "Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer". This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study co...

What is the current status of trial NCT03654547?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-01-08. Estimated completion is 2024-02-28.

What conditions does trial NCT03654547 study?

This clinical trial studies the following conditions: Advanced Solid Tumors, Triple Negative Breast Cancer.

What interventions are being tested in trial NCT03654547?

The interventions under investigation include: TT-00420 (DRUG).

Who is sponsoring clinical trial NCT03654547?

This trial is sponsored by TransThera Sciences (Nanjing), which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03654547 being conducted?

This trial has 2 study locations across Texas, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.