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NSCLCPhase 1NCT04204473

A Study of TY-9591 in Advanced Non-small Cell Lung Cancer(NSCLC) Patients With EGFR Positive Mutation

A Phase 1 study testing TY-9591(10mg,40mg) qd. po in people with NSCLC, run by TYK Medicines, Inc at 1 site in China.

Completed

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

Official record
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Trial summary

The primary objective of this study is to evaluate the safety and tolerability of TY-9591, with dose-escalation stage and dose-expansion stage. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
TY-9591(10mg,40mg) qd. po
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteChina
Study dates
7 May 2020to 18 May 2023
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75years old, male or female.
  • Histological or cytological confirmation diagnosis of NSCLC
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
  • Documentation of disease progression while on previous continuous treatment with first-line EGFR TKI; patients must have confirmation of tumor EGFR activating mutations (exon 19 del, or exon 21 ) and T790M mutation status
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  • Adequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • a.Neutrophils (absolute value) ≥ 1.5×10^9/L; b.Hemoglobin ≥ 90 g/L; c.Platelet ≥ 80×10^9/L; d.Serum total bilirubin ≤ 1.5× ULN（for Patients with Gilbert Syndrome, total bilirubin ≤ 3×ULN and bilirubin ≤ 1.5×ULN should be permitted） f. Aspartate aminotransferase(AST)、alanine aminotransferase(ALT) ≤ 2.5×ULN; for patients with hepatic metastases, AST、ALT ≤ 5×ULN; g. International standardized ratio (INR) < 1.5, and activated partial prothrombin time (APTT) < 1.5×ULN;
  • Female subjects have a negative urine or serum pregnancy.
  • Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.

Who cannot join

  • Treatment with any of the following:
  • Treatment with an EGFR TKI within 14 days or about 5x half-life, whichever is the longer, of the first dose of study drug;
  • Any cytotoxic chemotherapy, investigational agents or anticancer drugs for the treatment from a previous treatment regimen within 4 weeks of the first dose of study treatment;
  • Major surgery within 4 weeks of the first dose of study treatment;
  • Radiotherapy with a limited field of radiation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 4 weeks of the first dose of study treatment;
  • Previously treated by other third-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI) for T790M (for example Osimertinib).
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  • Patients currently receiving (or at least within 1 week prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4.
  • Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
  • Spinal cord compression or brain metastases unless asymptomatic.
  • Dysphagia, or active digestive system diseases or previous significant bowel resection or medical conditions potentially affect TY-9591 absorption.
  • Cardiac function and disease are consistent with the following:
  • Corrected QT interval(QTc)> 470 milliseconds from 3 electrocardiograms (ECGs);
  • Any clinically important abnormalities in rhythm;
  • Any factors that increase the risk of QTc prolongation;
  • Left ventricular ejection fraction (LVEF) <50%;
  • Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.
  • 7 .Previous history of interstitial lung disease(ILD)、drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.
  • 8. Previous allogeneic bone marrow transplant. 9. Hypersensitivity to TY-9591 or similar compounds or excipients. 10.Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, 201203

Other trials in China

About this study

Official title: Phase I, Open-label, Single-arm Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of TY-9591 Tablets in Advanced NSCLC Patients With Epidermal Growth Factor Receptor( EGFR) Positive Mutation

The primary objective of this study is to evaluate the safety and tolerability of TY-9591, with dose-escalation stage and dose-expansion stage.

Read the detailed description
  • To define the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D)
  • To investigate the pharmacokinetic profile of TY-9591 and its metabolites after single then multiple doses of TY-9591 administered orally once daily
  • To evaluate the anti-cancer activity of TY-9591 in NSCLC patients with EGFR mutation(ORR、PFS、DoR、DCR、and CBR)
Conditions
NSCLC
Being tested
TY-9591(10mg,40mg) qd. po

What participants receive

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

  • TY-9591(10mg,40mg) qd. poDrug

    Also called TY-9591

    Increased dose cohorts from low dose to MTD(20mg Cohort1, 40mg Cohort2, 80mg Cohort3,120mg Cohort4, 160mg Cohort5, 200mg Cohort6)

Study groups in NCT04204473
Study groupRoleWhat they receive
TY-9591ExperimentalFind maximum tolerated dose of TY-9591 given orally. Escalating doses of TY-9591 starting at 20mg daily.
Receives: Drug: TY-9591(10mg,40mg) qd. po

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    Incidence of Dose Limiting Toxicity (DLT)

    Measured: First 29 days of dosing

  2. Maximum Tolerated Dose (MTD)

    To determine the Maximum Tolerated Dose (MTD) of TY-9591 in subjects with NSCLC

    Measured: 1year

  3. Recommended Phase 2 dose (RP2D)

    Recommended Phase 2 dose (RP2D) of TY-9591 in subjects with NSCLC

    Measured: through study completion, an average of 2.5 years

  4. Overall Response Rate (ORR)

    ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: At least 24 weeks

Secondary outcomes (8)

  1. Cmax

    Cmax of TY-9591 following single dose

    Measured: pharmacokinetics(PK) blood samples are collected at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12, 24, 48, 72,96,120,144,168 and 192 hours post-dose.

  2. Tmax

    Tmax of TY-9591 following single dose

    Measured: pharmacokinetics(PK) blood samples are collected at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12, 24, 48, 72,96,120,144,168 and 192 hours post-dose.

  3. Area Under Curve(AUC)

    AUC of TY-9591 following single dose

    Measured: pharmacokinetics(PK) blood samples are collected at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12, 24, 48, 72,96,120,144,168 and 192 hours post-dose

  4. Cmax

    Cmax of TY-9591 following multiple dose

    Measured: The datas should be evaluated multiple times on Cycle 1 day1,8,15, 21 pre-dose; Cycle 2 day1 (at pre-dose, 0.5,1, 2, 3, 4, 6, 8, 10,12, 24 hours post-dose). Each cycle is 21 days

  5. Cmin

    Cmin of TY-9591 following multiple dose

    Measured: The datas should be evaluated multiple times on Cycle 1 day1,8,15, 21 pre-dose; Cycle 2 day1 (at pre-dose, 0.5,1, 2, 3, 4, 6, 8, 10,12, 24 hours post-dose). Each cycle is 21 days

  6. AUC

    AUC of TY-9591 following multiple dose

    Measured: The datas should be evaluated multiple times on Cycle 1 day1,8,15, 21 pre-dose; Cycle 2 day1 (at pre-dose, 0.5,1, 2, 3, 4, 6, 8, 10,12, 24 hours post-dose). Each cycle is 21 days

  7. Progression-free survival (PFS)

    PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by by Investigator assessment in accordance to RECIST 1.1

    Measured: 10.1 months

  8. Duration of Response (DOR)

    DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1

    Measured: 9.7 months

Timeline

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

  1. First posted19 Dec 2019
  2. Study start7 May 2020
  3. Primary completion3 Mar 2023
  4. Study completion18 May 2023

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04204473
Sponsor's protocol ID
TYKM1601101
Status last verified
Dec 2022
First submitted
12 Dec 2019
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Han B, Liu J, Wu L, Zhao Y, Zhang W, Chen B, He J, Shi J, Liu Y, Zhang Z, Chen X, Wu Y. Safety, Pharmacokinetics, and Efficacy of Asandeutertinib in Advanced EGFR-mutated NSCLC: A Phase 1 Dose-Escalation and Dose-Expansion Study. J Thorac Oncol. 2025 Jun;20(6):763-774. doi: 10.1016/j.jtho.2025.02.003. Epub 2025 Feb 8.

    PubMed 39929334

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TY-9591(10mg,40mg) qd. po in people with NSCLC, run by TYK Medicines, Inc at 1 site 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 10 inclusion and 18 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

Dose Limiting Toxicity (DLT) (time frame: First 29 days of dosing). The study lists 4 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 NCT04204473, which also lists 1 linked publication.

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 18 Nov 2023.

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