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Advanced Solid TumorPhase 1NCT05354843

SHP2 Inhibitor ET0038 Monotherapy in Patients With Advanced Solid Tumors

A Phase 1 study testing ET0038 in people with Advanced Solid Tumor, run by Etern BioPharma (Shanghai) Co., Ltd at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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, multi-center, dose-finding study to assess the safety, pharmacokinetics, and preliminary efficacy of ET0038 in patients with advanced solid tumors. It is anticipated that approximately 37 subjects will be enrolled in the dose-escalation phase of the study. 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?
ET0038
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesChina
Study dates
27 Oct 2021to 1 Oct 2025
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

  • Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
  • Aged at least 18 years at the time of ICF signature.
  • Histological or cytological confirmation of a solid tumor and have progressed despite standard therapy(ies), or are intolerant to standard therapy (ies), or have a tumor for which no standard therapy(ies) exists. Locally recurrent disease must not be amenable to surgical resection or radiotherapy with curative intent (patients who are considered suitable for surgical or ablative techniques following down-staging with study treatment are not eligible).
  • Estimated life expectancy of minimum of 12 weeks.
  • Patient with solid tumors must have at least 1 lesion, not previously irradiated, that can be accurately measured at pre-dose as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with Computerised Tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
  • Males and Females of child-bearing potential must agree to use effective contraception from the time ICF signature until 12 weeks after the last dose. Females of childbearing potential include those who are premenopausal and those who are 2 years postmenopausal. Pregnancy tests for female of child-bearing potential must have a negative serum pregnancy test at Screening.

Who cannot join

  • Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression.
  • As judged by the investigator, any evidence of significant ophthalmological abnormalities including but not limited to history or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO, retinal macular degeneration, uncontrolled glaucoma, cataract or marked decrease in visual acuity, symptomatic severe dry eye, conjunctivitis, or corneal ulcer.
  • Prior bone marrow or organ transplantation
  • Prior treatment with ET0038 or a SHP2 inhibitor.
  • Prior therapy with any investigational drugs or systemic anticancer treatment within 28 days (or a period of 5 'half-lives' of this investigational drugs or systemic anticancer treatment, whichever is the most appropriate and as judged by the investigator) at the time of ICF signature.
  • Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days at the time of ICF signature, or planning radical radiation therapy while participating in the study.
Show all 18Show fewer
  • Prior major surgery (excluding placement of vascular access) within 28 days at the time of ICF signature, or planning for major surgery while participating in the study.
  • With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE5.0) Grade 1 at the time of ICF signature.
  • Any uncontrolled active infection requiring parenteral administration of antibiotics, antivirals, or antifungals at the time of ICF signature and/or within one week of Cycle 1 Day 1 (C1D1).
  • Patient with a history of active pulmonary tuberculosis infection within 1 year prior to screening (as judged by investigator, active pulmonary tuberculosis infection more than 1 year and no evidence of active pulmonary tuberculosis at present will be considering eligible)
  • Patient with history or presence of interstitial lung disease or interstitial pneumonitis.
  • An active, or previously, autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease,autoimmune thyroid disease, vasculitis, and psoriasis etc.) or high risk to such diseases.
  • Active infection including hepatitis B (Hepatitis B surface antigen [HBsAg] positive), and/or hepatitis C (HCV-RNA positive).
  • Active human immunodeficiency virus (HIV) infection (Patient with HIV positive and have well-controlled disease is exception).
  • Patient inability or unwillingness to comply with requirement for oral drug administration or presence of a gastro-intestinal condition, e.g., Refractory nausea and vomiting, inability to swallow the formulated product or previous significant bowel resection.
  • Have a history or present active bleeding disease within 6 months at the time of ICF signature.
  • History of COVID-19 infections, or COVID-19 nucleic acid test positive at the time of ICF signature and/or prior to the first dose of study treatment.
  • Pregnant or Breast-feeding women

Trial locations and contacts

2 sites in 1 country.

Etern BioPharma (Shanghai) Co., Ltd contact

86 021 50186958

jianhua.yi@eternbio.com

China2 sites, 2 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Xia Wang, 186 7026 4387, xia.wang@linkstart.com.cn

    Recruiting

  • West China School of Medicine/West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Lizhu Zou, 18708119607, 2920056032@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of SHP2 Inhibitor ET0038 Monotherapy in Patients With Advanced Solid Tumors

This is a Phase I, open-label, multi-center, dose-finding study to assess the safety, pharmacokinetics, and preliminary efficacy of ET0038 in patients with advanced solid tumors. It is anticipated that approximately 37 subjects will be enrolled in the dose-escalation phase of the study. ET0038 will be administered orally once daily (QD) in 21-day treatment cycles.

Read the detailed description

This is an open-label, multicenter, Phase 1 study of oral ET0038 monotherapy in participants with advanced solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with advanced solid tumors and 2) a Dose-Expansion Component for participants with advanced solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the RAS-MAPK pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Being tested
ET0038

What participants receive

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

  • ET0038Drug

    ET0038 for oral administration

Study groups in NCT05354843
Study groupRoleWhat they receive
Dose Escalation and Dose ExpansionExperimentalET0038 will be administered orally once daily in 21 days treatment cycles.
Receives: Drug: ET0038

What is being measured

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

  1. RP2D of Phase 2 Dose of ET0038

    Find RP2D

    Measured: Approximately 2 years

  2. MTD of ET0038

    Fin MTD

    Measured: Approximately 2 years

  3. Number of participants with adverse events (AEs)

    All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments

    Measured: Approximately 2 years

Secondary outcomes (9)

  1. Area under the curve

    Area under the plasma concentration time curve of ET0038

    Measured: Approximately 2 years

  2. Cmax

    Highest observed plasma concentration of ET0038

    Measured: Approximately 2 years

  3. Tmax

    Time of highest observed plasma concentration of ET0038

    Measured: Approximately 2 years

  4. T1/2

    Half life of ET0038

    Measured: Approximately 2 years

  5. Objective response rate

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

    Measured: Approximately 2 years

  6. Duration of response

    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

    Measured: Approximately 2 years

  7. Disease Control Rate

    DCR is defined as the percentage of patients who achieved remission (PR+CR) and stabilization (SD) after treatment in evaluable cases.

    Measured: Approximately 2 years

  8. progression-free survival

    PFS is defined as the time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause).

    Measured: Approximately 2 years

  9. overall survival

    OS is defined as the time between the beginning of randomization and the death of the patient from any cause

    Measured: Approximately 2 years

Timeline

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

  1. First posted29 Apr 2022
  2. Study start27 Oct 2021
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion1 Oct 2025 (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
Sequential
Model description
Anticipated ET0038 Dose Escalation Schedule Cohort ET0038 dose at each treatment administration point 1\. SDL = 10 mg QD 2 .SDL × 2 = 20 mg QD 3. SDL × 4 = 40 mg QD 4 .SDL × 6 = 60 mg QD 5 .SDL × 8 = 80 mg QD Maximum Dose Level Abbreviations: QD=once a day; SDL=Starting Dose Level
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05354843
Sponsor's protocol ID
ET0038-101
Status last verified
Apr 2022
First submitted
17 Mar 2022
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ET0038 in people with Advanced Solid Tumor, run by Etern BioPharma (Shanghai) Co., Ltd at 2 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 7 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: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 Etern BioPharma (Shanghai) Co., Ltd (86 021 50186958, jianhua.yi@eternbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D of Phase 2 Dose of ET0038 (time frame: Approximately 2 years). The study lists 3 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 NCT05354843.

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 29 Apr 2022.

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