NCT03099330 is a Phase 1 clinical trial of TQ-B3139 in Advanced Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..

Who is sponsoring NCT03099330?

NCT03099330 is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..

What drugs are being tested in NCT03099330?

Interventions in NCT03099330: TQ-B3139.

What condition does NCT03099330 study?

NCT03099330 studies Advanced Cancer.

Is NCT03099330 still recruiting?

NCT03099330 is currently status unknown. Last updated 15 September 2017.

Last reviewed 2017-09-15 · How we verify

NCT03099330

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study of Tolerance and Pharmacokinetics of TQ-B3139 in Patients With Advanced Cancer

Status unknown Phase 1 Last updated 15 September 2017

What this trial tests

Phase 1 trial testing TQ-B3139 in Advanced Cancer in 20 participants. Status unknown.

Timeline

19 July 2017

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	19 July 2017
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across China

Drugs / interventions tested

TQ-B3139 — full drug profile →

Conditions studied

Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The maximum tolerated dose (MTD) of TQ-B3139
Time frame: 48 weeks
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3139
Time frame: For 4 weeks for DLTs
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever
Pharmacokinetics of TQ-B3139 (in whole blood):Peak Plasma Concentration(Cmax)
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.
Pharmacokinetics of TQ-B3139 (in whole blood):Peak time（Tmax）
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.
Pharmacokinetics of TQ-B3139 (in whole blood):Half life（t1/2）
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.
Pharmacokinetics of TQ-B3139 (in whole blood):Area under the plasma concentration versus time curve (AUC)
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.

Sponsor's own description

A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements.
Ma Y, Zhao H, Xue J, Liu L, et al · · 2022 · cited 9× · PMID 35940055 · DOI 10.1016/j.ejca.2022.06.037
Metastatic brain tumors: from development to cutting-edge treatment.
Tanzhu G, Chen L, Ning J, Xue W, et al · · 2025 · cited 8× · PMID 39712454 · DOI 10.1002/mco2.70020
Current treatment and novel insights regarding ROS1-targeted therapy in malignant tumors.
Li S, Zhang H, Chen T, Zhang X, et al · · 2024 · cited 4× · PMID 38629293 · DOI 10.1002/cam4.7201

Verify or expand the search:

Other trials of TQ-B3139

Trials testing the same drug.

NCT04398940 — A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer · Phase 2 · unknown
NCT04009317 — Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positi · Phase 3 · unknown
NCT04056572 — Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previous · Phase 2 · unknown

Other recruiting trials for Advanced Cancer

Currently open trials in the same condition.

NCT07393529 — A Pilot Randomized Controlled Trial of a Social Network Intervention · NA · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07246954 — A Chaplain-clinician Led Spiritual Care (PEACE) Intervention on Spiritual/Religious Beliefs Related to Medical Care in P · NA · recruiting
NCT06346197 — Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas · Phase 3 · recruiting
NCT07147023 — Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication · NA · active not recruiting

Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials

Trials by the same sponsor.

NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03099330 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last refreshed: 15 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03099330.

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