CLINICAL TRIALS PROFILE FOR TT-00420

Clinical Trials for TT-00420

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03654547 ↗	Safety of TT-00420 Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer	Active, not recruiting	TransThera Biosciences Co., Ltd	Phase 1	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.
NCT03654547 ↗	Safety of TT-00420 Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer	Active, not recruiting	TransThera Sciences (Nanjing), Inc.	Phase 1	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.
NCT04705922 ↗	Relative Bioavailability Study and Food Effect Study of TT-00420 Capsule and Tablet Formulations in Healthy Volunteers	Completed	TransThera Biosciences Co., Ltd	Phase 1	This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet.
NCT04705922 ↗	Relative Bioavailability Study and Food Effect Study of TT-00420 Capsule and Tablet Formulations in Healthy Volunteers	Completed	TransThera Sciences (Nanjing), Inc.	Phase 1	This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet.
NCT04742959 ↗	Study of TT-00420 Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors	Recruiting	TransThera Biosciences Co., Ltd	Phase 1/Phase 2	This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors.

Clinical Trial Conditions for TT-00420

Condition Name

Condition Name for
Intervention	Trials
Cholangiocarcinoma	3
Triple Negative Breast Cancer	3
Bladder Cancer	2
Small-cell Lung Cancer	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Cholangiocarcinoma	3
Triple Negative Breast Neoplasms	3
Breast Neoplasms	3
Small Cell Lung Carcinoma	2

Clinical Trial Locations for TT-00420

Trials by Country

Trials by Country for
Location	Trials
United States	7
China	2

Trials by US State

Trials by US State for
Location	Trials
Texas	3
California	2
New Jersey	1
Maryland	1

Clinical Trial Progress for TT-00420

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	2
Active, not recruiting	1
Completed	1

Clinical Trial Sponsors for TT-00420

Sponsor Name

Sponsor Name for
Sponsor	Trials
TransThera Sciences (Nanjing), Inc.	5
TransThera Biosciences Co., Ltd	4

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	9