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Non-small Cell Lung CancerPhase 1NCT03603262

Safety, Tolerability and Pharmacokinetics of SH-1028 in Patients With Advanced NSCLC

A Phase 1 study testing SH-1028 in people with Non-small Cell Lung Cancer, run by Nanjing Sanhome 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 The sponsor has not verified this record for over two years, so it may be out of date.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 1, open-label study of SH-1028 with dose escalation and dose expansion cohorts in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
SH-1028
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteChina
Study dates
25 Apr 2018to Dec 2019
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

  • Age from 18 to 75, both sexes.
  • Histologically or cytologically documented NSCLC.
  • Not amenable to radical therapy or stage IV.
  • Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib. In addition, other lines of therapy may have been given(chemotherapy only accept first line).
  • Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria while on continuous treatment with an EGFR TKI(PR/CR、or SD continued ≥6 months).
  • Patients must have confirmation of tumor T790M+ mutation status.
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  • Patients also must have confirmation of tumor T790M+ mutation status.
  • World Health Organization (WHO) performance status equal to 0-1 with no deterioration over the previous 2 weeks.
  • A minimum life expectancy of 12 weeks.
  • At least 1 lesion that has not previously been irradiated, that can be accurately measured at Baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), which is suitable for accurately repeated measurements.
  • Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding during the study and until 6 months after completion of study, and must have a negative pregnancy test prior to start of dosing.
  • Male patients should be willing to use barrier contraception during the study and until 6 months after completion of study (i.e., condoms).
  • Do not anticipate other clinical trail in 3 months.
  • The patient must provide a written informed consent for genetic research.

Who cannot join

  • Not Confirmed by pathology.
  • An EGFR TKI within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer, of the first dose of study treatment.
  • Any cytotoxic chemotherapy used for a previous treatment regimen or clinical study within 21 days of the first dose of study treatment; Any target medicines used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment; withdrawal other clinical drugs or anti-cancer drugs less than 5 times the half-life.
  • Ever used the third EGFR-TKI, such as AZD9291,CO-1686 or avitinib.
  • Major surgery within 4 weeks of the first dose of study treatment.
  • Radiotherapy with a limited field of radiation for palliation 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 which must be completed within 4 weeks of the first dose of study treatment.
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  • The patient is currently using (or cannot discontinue at least 1 week before the first dose of study treatment) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.
  • Use large doses of glucocorticoids or other immunosuppressive agents within 4 weeks.
  • 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, stable, and not requiring steroids for at least 4 weeks prior to start of study treatment.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial.
  • Active infection (e.g., hepatitis B, hepatitis C or human immunodeficiency virus [HIV]). (HBsAg is positive but HBV-DNA <1×103 IU/ mL ,and HCVAb is positive but HCV-RNA<103 IU/mL can be accepted.）.
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic ECG machine and Fridericia's formula for QT interval correction.
  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250msec).
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Absolute neutrophil count < 1.5 x 109/L.
  • Platelet count < 100 x 109/L.
  • Hemoglobin < 90 g/L (< 9 g/dL).
  • Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.
  • Aspartate aminotransferase > 2.5 times the ULN if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.
  • Total bilirubin > 1.5 times the ULN if no liver metastases or > 3 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.
  • Creatinine > 1.5 times the ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by the Cockcroft - Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times the ULN.
  • Have any other malignant tumor within five years (except clinically cured cervical carcinoma in situ, basal cells or squamous epithelial skin cancer).
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to swallow the study medication, or previous significant bowel resection that would preclude adequate absorption of SH-1028.
  • History of hypersensitivity to any active or inactive ingredient of SH-1028 or to a drug with a similar chemical structure or class to SH-1028.
  • Women who are breast feeding.
  • Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.

Trial locations and contacts

1 site in 1 country.

SHU YONGQIAN, MD contact

+8613951017570

shuyongqian@csco.org.cn

China1 site, 1 recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000

    Shu yangqian, MD

    Shu yongqian, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of SH-1028 Tablets in Patients With Advanced Non-small Cell Lung Cancer

This is a Phase 1, open-label study of SH-1028 with dose escalation and dose expansion cohorts in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent.

Read the detailed description

The study is designed to evaluate safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally (PO) administered SH-1028 tablets. The overall study design is shown in the flow chart below, which consists of 2 phases: dose escalation and dose expansion cohort.

Being tested
SH-1028
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • SH-1028Drug

    Starting dose 60mg,oral administered once daily.If tolerated subsequent cohorts will test increasing doses (100mg,200mg,300mg,400mg) of SH-1028.

Study groups in NCT03603262
Study groupRoleWhat they receive
SH-1028ExperimentalOral Once-Daily Administration of SH-1028
Receives: Drug: SH-1028

What is being measured

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

  1. Maximum tolerated dose (MTD)

    Measured: Within the first 28 days of treatment

  2. Incidence of Dose Limiting Toxicity (DLT)

    Measured: Within the first 28 days of treatment

  3. Area under the plasma concentration versus time curve (AUC) of SH-1028

    Measured: 4 weeks

  4. Elimination half-life(T1/2) of SH-1028

    Measured: 4 weeks

  5. Maximum (or peak) concentration of SH-1028

    Measured: 4 weeks

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    Measured: 12 months

  2. Progression-free survival (PFS)

    Measured: 12 months

  3. Disease control rates（DCR）

    Measured: 12 months

  4. Overall survival（OS）

    Measured: 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 Jul 2018
  2. Study start25 Apr 2018
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (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
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603262
Sponsor's protocol ID
SHC013-I-01
Status last verified
Jul 2018
First submitted
4 Jul 2018
Last updated
28 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • He J, Ma P, Zhao D, Shi X, Guo R, Gao W, Shu Y. Safety, efficacy, and pharmacokinetics of SH-1028 in EGFR T790M-positive advanced non-small cell lung cancer patients: A dose-escalation phase 1 study. Cancer. 2023 May 15;129(10):1513-1522. doi: 10.1002/cncr.34697. Epub 2023 Feb 22.

    PubMed 36813747

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SH-1028 in people with Non-small Cell Lung Cancer, run by Nanjing Sanhome 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 14 inclusion and 30 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 28 Jan 2019. 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 SHU YONGQIAN, MD (+8613951017570, shuyongqian@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: Within the first 28 days of treatment). The study lists 5 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 NCT03603262, 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 28 Jan 2019.

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