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Advanced Solid TumorPhase 1/2NCT05253053

To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors

A Phase 1/2 study testing TT-00420, Combination Product: Atezolizumab and Combination Product: Nab-Paclitaxel in people with Advanced Solid Tumor and Cholangiocarcinoma, run by TransThera Sciences (Nanjing), Inc. at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TT-00420, Combination Product: Atezolizumab and Combination Product: Nab-Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
9 sitesChina
Study dates
13 Apr 2022to 31 Aug 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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] )
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  • 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
  • 6. 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:
  • AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 × ULN if liver metastases are present .
  • Total bilirubin ≤ 1.5 × ULN or direct bilirubin<ULN (if total bilirubin>1.5 ULN).
  • Patients with hepatocellular carcinoma (HCC) and BTC: Child Pugh A or B (Score ≤ 7).
  • Renal fuction:
  • serum creatinine ≤ 1.5 × ULN or Calculated 24-hour clearance ≥ 50 mL/min (Cockcroft Gault formula).
  • Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 6 months after ceasing study treatment
  • Able to sign informed consent and comply with the protocol

Who cannot join

  • 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
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  • 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
  • Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who have undergone major surgery or wide field radiotherapy ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who are currently receiving treatment with strong CYP3A inhibitors or inducers ≤ 2 weeks prior to starting study drug.
  • Patients who have used of proton pump inhibitors (PPIs) within 4 days or histamine H2 blockers within 2 days prior to starting study drug
  • Human Immunodeficiency Virus (HIV) positive
  • Patients with active HBV infection (HBV DNA copy number ≥ ULN) and/or HCV infection (HCV RNA copy number ≥ ULN)
  • Patients with active tuberculosis
  • Has received a live-virus vaccination within 30 days of planned first dose Note：Seasonal flu and COVID-19 vaccines are permitted before enrollment at least 7 days.
  • Patients with a history of medical conditions, treatment, or abnormal laboratory tests that could affect the results of the study, interfere with study participation and compliance per investigator's judgment
  • 【Note】：The following three types of patients may be enrolled after being determined by the sponsor:
  • ①Patients who have received emergency, low-dose, systemic immunosuppressive therapy (for example, one-time dexamethasone administration for vomiting);
  • ② Patients who need steroid prophylaxis and have a history of intravenous contrast agent allergic reactions should use MRI for baseline and follow-up tumor assessment;
  • ③The use of inhaled corticosteroids to treat chronic obstructive pulmonary disease, the use of mineralocorticoids (such as fludrocortisone) to treat patients with orthostatic hypotension and the use of low-dose supplementary corticosteroids to treat adrenal insufficiency are permitted.
  • Arm B: TT-00420 tablet in combination with Atezolizumab Injection (Tecentriq ®): Subjects who meet one or more of the following criteria are also not allowed to participate in this study.
  • A history of severe allergies, immune stress, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Known to have hypersensitivity or allergies to any ingredient of Chinese hamster ovary cells or atelizumab injection.
  • History of autoimmune diseases, including but not limited to myasthenia gravis, autoimmune myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, and antiphospholipid syndrome related Vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
  • 【Note】The following two types of patients may be enrolled after being determined by the sponsor: ① Patients who have a history of autoimmune hypothyroidism but have stable doses of thyroid replacement hormone therapy; ② Patients who use stable doses of insulin therapy to control type I diabetes may can be enrolled.
  • Patients who have a history of allogeneic stem cell or solid organ transplantation.
  • Patients who have a history of non-specific pulmonary fibrosis, tissue pneumonia (such as: bronchiolitis obliterans, unknown tissue pneumonia), drug-induced pneumonia, or active pneumonia showed by chest CT scan.
  • 【Note】radiation pneumonitis (fibrosis) exist in the radiation area can be enrolled.
  • Patients who have received systemic immunostimulatory drugs therapy (including but not limited to interferon or IL-2) ≤ the shorter one of 4 weeks or 5 half-lives of immunostimulatory drugs.
  • Patients who have received systemic corticosteroids or other systemic immunosuppressive drugs (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, and Tumor Necrosis Factor (TNF)) within 2 weeks prior to starting study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Beijing Cancer Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Fudan Univisity Shanghai Cancer Center

    Shanghai

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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

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).

Read the detailed description

Study consists of three arms, Arm A is a Phase Ib/II study of TT-00420 tablet monotherapy, Arm B is a Phase Ib/II study of TT-00420 tablet in combination with atezolizumab (Tecentriq®), and Arm C is a Phase Ib/II study of TT-00420 tablet in combination with nab-paclitaxel (Abraxane®).

Arm A: TT-00420 Tablet Monotherapy Phase Ib will enroll patients with preferred indications including 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 to receive TT-00420 monotherapy. Phase Ib will be a dose escalation study of TT-00420 in combination, guided by 3+3 design, to determine a Recommended Phase 2 Dose (RP2D). Based on preliminary efficacy results, Phase II will enroll additional patients in select indications to evaluate the efficacy of TT-00420 monotherapy.

Arm B: TT-00420 tablet in combination with atezolizumab (Tecentriq®) Arm B will enroll patients with advanced biliary tract cancer. Phase Ib will be a dose escalation study of TT-00420 in combination with nab-paclitaxel, guided by 3+3 design, to determine a Recommended Phase 2 Dose (RP2D). Phase II will enroll additional patients with advanced biliary tract cancer to further evaluate the efficacy of the combination regimen.

Arm C: TT-00420 tablet in combination with nab-paclitaxel (Abraxane®) Arm C will enroll patients with advanced triple-negative breast cancer (TNBC). Phase Ib will be a dose escalation study of TT-00420 in combination with nab-paclitaxel, guided by 3+3 design, to determine a Recommended Phase 2 Dose (RP2D). Phase II will enroll additional patients with advanced TNBC to further evaluate the efficacy of the combination regimen.

Being tested
TT-00420, Combination Product: Atezolizumab, Combination Product: Nab-Paclitaxel
Medical subject headings
Cholangiocarcinoma, Biliary Tract Neoplasms, Triple Negative Breast Neoplasms, Small Cell Lung Carcinoma, Urinary Bladder Neoplasms, Prostatic Neoplasms, Thyroid Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TT-00420Drug

    TT-00420 tablet will be administered orally once daily per protocol defined schedule.

  • Combination Product: AtezolizumabDrug

    Atezolizumab would be administered via infusion on Day 1 of 21-day cycle

  • Combination Product: Nab-PaclitaxelDrug

    Nab-Paclitaxel would be administered via infusion on Day 1 and 8 of 21-day cycle

Study groups in NCT05253053
Study groupRoleWhat they receive
Arm A: TT-00420 Tablet MonotherapyExperimentalTT-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).
Receives: Drug: TT-00420
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).
Receives: Drug: TT-00420; Drug: Combination Product: Atezolizumab
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).
Receives: Drug: TT-00420; Drug: Combination Product: Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 30 days from the last dose

  2. Dose limiting toxicity (DLT)

    Dose escalation cohorts are monitored and assessed using the NCI Common Toxicity Criteria for Adverse Events, version 5.0.

    Measured: Up to 21 days from the first dose

Secondary outcomes (11)

  1. Objective Response Rate (ORR)

    The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.

    Measured: Through study completion, an average of 9 months

  2. Disease Control Rate (DCR)

    Defined as CR + PR + stable disease (SD) based on RECIST version 1.1.

    Measured: Through study completion, an average of 9 months

  3. Duration of Objective Response (DOR)

    Duration of response for CR or PR based on RECIST version 1.1.

    Measured: Through study completion, an average of 9 months

  4. Progression Free Survival (PFS)

    Measured: 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

  5. Overall Survival (OS)

    Measured: From first study drug administration until the date of death from any cause, assessed up to 24 months

  6. Area under the curve (AUC0-∞)

    Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420

    Measured: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 21 days)

  7. Area under the curve (AUC0-t)

    Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420

    Measured: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 21 days)

  8. Maximum observed concentration (Cmax)

    Blood samples will be collected at designated time points for pharmacokinetic

    Measured: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 21 days)

  9. Half-life (T1/2)

    Measured: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 21 days)

  10. Time to Maximum Concentration (Tmax)

    Measured: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 21 days)

  11. Volume of Distribution

    Measured: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start13 Apr 2022
  3. Primary completion31 Aug 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Study will consist of three arms: Arm A (TT-00420 Tablet Monotherapy), Arm B (TT-00420 tablet in combination with atezolizumab(Tecentriq®)) and Arm C (TT-00420 tablet in combination with nab-paclitaxel (Abraxane®)).
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253053
Sponsor's protocol ID
TT00420CN04
Status last verified
Jun 2025
First submitted
26 Jan 2022
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TT-00420, Combination Product: Atezolizumab and Combination Product: Nab-Paclitaxel in people with Advanced Solid Tumor and Cholangiocarcinoma, run by TransThera Sciences (Nanjing), Inc. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (time frame: Up to 30 days from the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05253053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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