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.
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.
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- 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.
China2 sites, 2 recruiting
- 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
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.
- Conditions
- Advanced Solid Tumor
- 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 group | Role | What they receive |
|---|---|---|
| Dose Escalation and Dose Expansion | Experimental | ET0038 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.
RP2D of Phase 2 Dose of ET0038
Find RP2D
Measured: Approximately 2 years
MTD of ET0038
Fin MTD
Measured: Approximately 2 years
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)
Area under the curve
Area under the plasma concentration time curve of ET0038
Measured: Approximately 2 years
Cmax
Highest observed plasma concentration of ET0038
Measured: Approximately 2 years
Tmax
Time of highest observed plasma concentration of ET0038
Measured: Approximately 2 years
T1/2
Half life of ET0038
Measured: Approximately 2 years
Objective response rate
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: Approximately 2 years
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
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
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
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.
- First posted29 Apr 2022
- Study start27 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Etern BioPharma (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etern BioPharma (Shanghai) Co., Ltd, Principal investigator, Etern BioPharma (Shanghai) Co., Ltd
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05354843
- Acronym / sponsor ID
- ET0038-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Etern BioPharma (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Dose Expansion | Experimental | Drug: ET0038ET0038 will be administered orally once daily in 21 days treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ET0038ET0038 for oral administration | Drug | Dose Escalation and Dose Expansion |
Primary outcome
RP2D of Phase 2 Dose of ET0038
Time frame: Approximately 2 years
Find RP2D
MTD of ET0038
Time frame: Approximately 2 years
Fin MTD
Number of participants with adverse events (AEs)
Time frame: Approximately 2 years
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
9 secondary outcomes
Area under the curve
Time frame: Approximately 2 years
Cmax
Time frame: Approximately 2 years
Tmax
Time frame: Approximately 2 years
T1/2
Time frame: Approximately 2 years
Objective response rate
Time frame: Approximately 2 years
Duration of response
Time frame: Approximately 2 years
Disease Control Rate
Time frame: Approximately 2 years
progression-free survival
Time frame: Approximately 2 years
overall survival
Time frame: Approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etern BioPharma (Shanghai) Co., Ltd principal investigator
Etern BioPharma (Shanghai) Co., Ltd
2 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 7 Nov 2026.