To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
A Phase Ib/II Study of TT-00420 Tablet, as Monotherapy or in Combination Regimens, to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumor
1 other identifier
interventional
84
1 country
9
Brief Summary
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 (solid tumor, BTC and TNBC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2022
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedStudy Start
First participant enrolled
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedJune 12, 2025
June 1, 2025
2.4 years
January 26, 2022
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
As assessed per NCI Common Toxicity Criteria for Adverse Events, version 5.0
Up to 30 days from the last dose
Dose limiting toxicity (DLT)
Dose escalation cohorts are monitored and assessed using the NCI Common Toxicity Criteria for Adverse Events, version 5.0.
Up to 21 days from the first dose
Secondary Outcomes (11)
Objective Response Rate (ORR)
Through study completion, an average of 9 months
Disease Control Rate (DCR)
Through study completion, an average of 9 months
Duration of Objective Response (DOR)
Through study completion, an average of 9 months
Progression Free Survival (PFS)
From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
From first study drug administration until the date of death from any cause, assessed up to 24 months
- +6 more secondary outcomes
Other Outcomes (2)
Potential relationship between efficacy and biomarkers
Through study completion, an average of 9 months
changes of main circulating metabolites of TT-00420 in plasma
Through study completion, an average of 9 months
Study Arms (3)
Arm A: TT-00420 Tablet Monotherapy
EXPERIMENTALTT-00420 tablets will be administered once daily in 21-day cycles. Dose escalation will be guided by a 3+3 design in Phase Ib to determine the recommended phase 2 dose (RP2D).
Arm B: TT-00420 tablet in combination with Atezolizumab Injection (Tecentriq ®)
EXPERIMENTALTT-00420 tablets will be administered once daily in 21-day cycles. Atezolizumab(1200 mg/20 mL) will be administered intravenously on Day 1 of each 21-day cycle. Dose escalation will be guided by a 3+3 design in Phase Ib to determine the recommended phase 2 dose (RP2D).
Arm C: TT-00420 tablet in combination with nab-paclitaxel (Abraxane®)
EXPERIMENTALTT-00420 tablets will be administered once daily in 21-day cycles. Nab-paclitaxel 125 mg/m\^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle. Dose escalation will be guided by a 3+3 design in Phase Ib to determine the recommended phase 2 dose (RP2D).
Interventions
TT-00420 tablet will be administered orally once daily per protocol defined schedule.
Atezolizumab would be administered via infusion on Day 1 of 21-day cycle
Nab-Paclitaxel would be administered via infusion on Day 1 and 8 of 21-day cycle
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Arm A：Histopathological or cytologically documented locally advanced or metastatic and solid tumors（including but not limited to advanced cholangiocarcinoma, small cell lung cancer, HER2-negative breast cancer including TNBC, bladder cancer, prostate cancer, thyroid cancer, gastric cancer, gallbladder cancer and other advanced solid tumors.
- Arm B：Histopathological or cytologically documented locally advanced or metastatic and Unresectable advanced biliary tract malignant tumors (except ampullary carcinoma).
- Arm C：
- Histopathological invasive advanced TNBC with triple-negative receptor status that meets the institution standards was proved ER or PR by IHC (positive tumor nucleus\<10% )
- HER2-negative (ASCO-CAP guideline \[Wolff A C, 2018\] )
- Received all currently available standard treatments (unless the treatment is contraindicated, intolerable, or unavailable for any reason)
- At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- \. Adequate organ and bone marrow function(without receiving any hematopoietic growth factor, blood or platelet therapy within 1 week before the first dose.
- Complete blood count (CBC):
- Absolute Neutrophil Count (ANC)≥ 1.5 × 109/L
- Hemoglobin（Hgb）≥ 9 g/dl
- Platelets（Plt）≥ 75 × 109/L
- Liver function:
- +7 more criteria
You may not qualify if:
- Patients who meet one or more of the following criteria will not be included in this study:
- Women who are pregnant or lactating
- Women of child-bearing potential (WOCBP) who do not use adequate birth control
- Patients with any hematologic malignancy, including leukemia (any form), lymphoma, and multiple myeloma
- Patients with a history of
- primary central nervous system tumors or
- carcinomatous meningitis (also known as leptomeningeal disease). Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment.
- Impaired cardiac function or significant diseases, including but not limited to any of the following:
- left ventricular ejection fraction (LVEF) \< 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO)
- Congenital long QT syndrome
- QTcF ≥ 450 msec on screening ECG
- Unstable angina pectoris ≤ 3 months prior to starting study drug
- Acute myocardial infarction ≤ 3 months prior to starting study drug
- Patients who are currently receiving treatment with medication that has known risk to prolong the QT interval or induce Torsades de Pointes, and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug.
- Patients with impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of TT-00420
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
Shandong Cancer Hospital
Jinan, Shandong, China
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Fudan Univisity Shanghai Cancer Center
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2022
First Posted
February 23, 2022
Study Start
April 13, 2022
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share