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Advanced Solid TumorPhase 1NCT05058352

A Study of HS269 in Patients With Advanced Solid Tumors

A Phase 1 study testing HS269 in people with Advanced Solid Tumor, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase I, open-label, first in human study of HS269 tablet, a small molecule highly-selective RET Inhibitor. The dose-escalation study will assess the safety, tolerability, and pharmacokinetics of HS269 and determine the dose and schedule to be used in Phase II. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HS269
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
Oct 2021to Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years, no gender limit.
  • Patients with advanced solid tumors confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment, or standard treatment is not applicable at this stage.
  • At least one evaluable tumor lesion according to RECIST version 1.1.
  • ECOG≤ 1.
  • The estimated survival time was more than 3 months.
  • The function of all organs was good, the specific indexes were as follows:
  • Blood system (no transfusion or hematopoietic stimulating factor treatment within 14 days) i. #NEUT ≥1.5×109/L ii. PLT ≥90×109/L iii. HGB ≥85g/L Liver function i. TBIL ≤1.5×ULN ii. ALT ≤3×ULN; Patients with liver metastasis or liver cancer: ≤ 5 × ULN iii. AST ≤3×ULN; Patients with liver metastasis or liver cancer: ≤ 5 × ULN Renal function i. Ccr >50 ml/min（According to Cockcroft-Gault formula） Blood coagulation function i. APTT ≤1.5×ULN ii. INR ≤1.5×ULN
  • The subjects should be informed and agreed to the study before the start of the trial, and sign the written informed consent voluntarily.

Who cannot join

  • Received anti-tumor treatments within 14 days or less than 5 half-lives (whichever is longer) before the first use of the study drug
  • Received blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor and other treatments within 7 days before receiving blood system examination during the screening period.
  • Received other unmarketed clinical study drugs or treatments within 4 weeks before the first use of the study drug.
  • Major organ surgery (excluding biopsy) or significant trauma occurred within 4 weeks before the first use of the study drug;
  • Systemic administration of glucocorticoids (prednisone > 10 mg / day or equivalent dose of the same drug) or other immunosuppressants within 14 days before the first use of the study drug; except for local, eye, intra articular, nasal and inhaled corticosteroids; short-term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy)；
  • CYP1A2/P-gp potent inhibitors or potent inducers were used within 7 days before the first use of the study drug；
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  • Resistance to selective RET inhibitors;
  • The adverse reactions of previous anti-tumor therapy have not yet recovered to CTCAE 5.0 grade evaluation ≤ 1 (except for the toxicity without safety risk judged by researchers such as alopecia)；
  • Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that the central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for the study.
  • Have active infection and need systemic anti infection therapy；
  • Have a history of immunodeficiency, including HIV antibody test positive；
  • Active hepatitis B, allowing preventive antiviral treatment other than interferon; hepatitis C virus infection；
  • Present or past interstitial lung disease (except radiation-induced pulmonary fibrosis without hormone therapy)；
  • Poorly controlled diabetic patients.
  • Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • Serious abnormal cardiac rhythm or conduction, such as ventricular arrhythmia, Ⅱ - Ⅲ degree atrioventricular block, etc;
  • In the resting state, average QTcF≥480ms in 12 lead -ECG；
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular events of grade 3 or above occurred within 6 months before the first administration;
  • NYHA ≥II or LVEF<50％；
  • Hypertension beyond clinical control；
  • Could not take medication orally，or have severe gastrointestinal obstruction (such as gastrointestinal obstruction, gastrointestinal absorption)；
  • The third space effusion, which could not be controlled clinically, was not suitable for the study；
  • Mental disorder or poor compliance；
  • Eligible patients with fertility (male and female) do not agree to use reliable contraceptive methods (abstinence, condom, intrauterine device or ligation) with their partner during the trial and for at least 3 months after the last medication.
  • Female patients have a positive blood pregnancy test within 7 days before enrollment, or breastfeeding women;
  • The subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons according to the investigator 's judgment.

Trial locations and contacts

1 site in 1 country.

Caicun Zhou contact

021-65115006

caicunzhoudr@163.com

Wei Li contact

021-65115006

leewluck@gmail.com

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai

    Caicun Zhou

Other trials in China

About this study

Official title: A Phase I, Open-label，Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS269, in Patients With Advanced Solid Tumor

This is a Phase I, open-label, first in human study of HS269 tablet, a small molecule highly-selective RET Inhibitor. The dose-escalation study will assess the safety, tolerability, and pharmacokinetics of HS269 and determine the dose and schedule to be used in Phase II. Seventeen to thirty-six patients with advanced solid tumor may be enrolled in this study.

Being tested
HS269

What participants receive

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

  • HS269Drug

    Oral tablets, once daily. Dose escalation from 50 mg QD, through 100 mg, 200mg, 300 mg, 400 mg, to 500mg.

Study groups in NCT05058352
Study groupRoleWhat they receive
HS269ExperimentalMultiple doses of HS269 tablets
Receives: Drug: HS269

What is being measured

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

  1. Dose limiting toxicities (DLT)

    Incidence rate of dose limiting toxicities (DLT)

    Measured: From date of initial dose until up to 33 days for treatment

  2. Adverse Event(s) and Serious Adverse Event(s)

    The occurrence and rate of AE and SAE

    Measured: Through study completion or early study discontinuation（up to 12 months）

Secondary outcomes (8)

  1. Peak Plasma Concentration (Cmax)

    Cmax of HS269

    Measured: From date of initial dose until up to 33 days for treatment

  2. Area Under the Plasma Concentration versus Time Curve (AUC)

    AUC of HS269

    Measured: From date of initial dose until up to 33 days for treatment

  3. Calcitonin in Peripheral Blood

    For Medullary Thyroid Cancer patients

    Measured: Through study completion or early study discontinuation（up to 12 months）

  4. Thyroglobulin in Peripheral Blood

    For non-MTC thyroid cancer patients

    Measured: Through study completion or early study discontinuation（up to 12 months）

  5. ORR

    Objective response rate (ORR)

    Measured: Approximately 12 months

  6. DCR

    Disease control rate (DCR)

    Measured: Approximately 12 months

  7. PFS

    Progression free survival (PFS)

    Measured: Approximately 12 months

  8. Peripheral blood ctDNA

    Only for patients with positive RET gene mutation

    Measured: Through study completion or early study discontinuation（up to 12 months）

Timeline

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

  1. First posted27 Sep 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionApr 2023 (estimated)

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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05058352
Sponsor's protocol ID
HS269-Ⅰ-01
Status last verified
Sep 2021
First submitted
2 Sep 2021
Last updated
27 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS269 in people with Advanced Solid Tumor, run by Zhejiang Hisun Pharmaceutical Co. Ltd. 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 8 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 27 Sep 2021. 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?

Results are not available in the source record.

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

Contact Caicun Zhou (021-65115006, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLT) (time frame: From date of initial dose until up to 33 days for treatment). 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 NCT05058352.

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 27 Sep 2021.

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