Advanced Solid TumorPhase 1NCT04801095
A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors
A Phase 1 study testing WM-S1-030 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Wellmarker Bio at 6 sites in 2 countries.
Trial summary
This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor, Colorectal Cancer
- What is being tested?
- WM-S1-030
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 14 Jul 2021to 8 Aug 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
- Aged ≥18 years.
- Able and willing to sign the informed consent form (ICF).
- Have at least 1 evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor which has progressed after treatment with standard therapies and for which no effective standard therapy is available or patient has refused, has a contraindication, or is intolerant to standard therapies.
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Must have archived frozen tissue available (collected within 3 months before screening) or consent to a pre-treatment biopsy.
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- Must be willing to consent to up to 2 on-treatment biopsies.
- Have a life expectancy of at least 12 weeks.
- Have adequate hematological functions and blood coagulation.
- Have adequate hepatic function at screening.
- Have adequate renal function at screening.
- QT interval corrected for heart rate using Fridericia's method ≤470 msec.
- Agree to abide by contraception requirements.
- Body mass index between 18 and 35 kg/m2 (exclusive)
Who cannot join
- Have received any prior approved or investigational treatment with RON and/or tyrosine-protein kinase Met (hepatocyte growth factor receptor) such as rilotumumab or crizotinib.
- Have received any cytotoxic chemotherapy, investigational agent (or medical device), anticancer drug, hormone therapy, or radiation therapy for treatment within 4 weeks or therapeutic radiopharmaceuticals taken within 8 weeks prior to the first administration of IP. Point (or limited) radiation to a site of bone pain, with the exception of patients receiving radiation to more than 30% of the bone marrow, will be allowed.
- Have known hypersensitivity to WM-S1-030 and/or excipient.
- Have ≥ Grade 2 unresolved toxicity related to prior anticancer therapy excluding alopecia.
- Have received drugs or herbal supplements within 2 weeks prior to the first administration of IP which are known to be inhibitors or inducers of cytochrome P450 (CYP)3A4 including, but not limited to, cannabinoids, ketoconazole, itraconazole, posaconazole, voriconazole, rifampicin, phenytoin, St. John's Wort, carbamazepine, or hyperforin.
- Have any primary central nervous system (CNS) tumors or known CNS metastases unless clinically stable (defined as without evidence of progression by imaging at least 4 weeks prior to the first administration of IP; any neurologic symptoms have returned to baseline), no evidence of new or enlarging brain metastases, and not using steroids or seizure medications (unless on stable doses) for at least 7 days prior to the first administration of IP.
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- Have previously undergone drainage of ascites and/or pleural effusion within 4 weeks prior to screening, or have clinically significant effusions at screening.
- Have any of the following ocular criteria:
- Symptomatic retinal vein occlusion or central serous retinopathy defined as fluid accumulation between the retinal pigment epithelium and the outer segment of the eye
- Symptomatic neovascular age related macular degeneration (neovascular/wet age related macular degeneration) or non proliferative diabetic retinopathy with macular edema
- Uncontrolled glaucoma, defined as intraocular pressure >21 mmHg despite treatment or history of previous glaucoma filtration surgery
- Presence of active intraocular inflammation, uveitis, keratitis, keratoconjunctivitis, keratopathy, corneal abrasion inflammation, or ulceration
- Any other clinically significant risk factor for ocular disorders described above
- Have had major surgery within 4 weeks prior to the first administration of IP. Patients should have recovered from the effects of major surgery or significant traumatic injury within 14 days prior to administration of the IP. Major surgery is defined as requiring more extensive procedure than that including local anesthesia (general anesthesia, respiratory assistance, or regional anesthesia) or open biopsy.
- Have serious non-healing wounds, ulcers, or bone fractures, except for traumatic fractures not requiring surgical intervention.
- Have an active infection treated with systemic anti-infectives within 2 weeks prior to the first administration of IP. Prophylactic anti-infectives that are not inhibitors or inducers of CYP3A4 are permitted.
- Have concurrent unstable or uncontrolled systemic diseases such as the following:
- Uncontrolled hypertension despite treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
- Clinically significant arrhythmia, unstable angina, congestive heart failure (class III or IV of New York Heart Association), or acute myocardial infarction within 6 months prior to screening
- Concurrent active systemic infections requiring systemic antibiotics or antifungals (exception for management of cetuximab-related rash)
- Active infections of hepatitis B, hepatitis C, or history of human immunodeficiency virus
- Any other chronic disease, which, at the discretion of the investigator, could jeopardize the safety of patients or patients' compliance with the protocol.
- Clinically significant venous thromboembolism requiring systemic anticoagulant (exception for prophylactic use)
- Have a history of gastrointestinal or trachea-esophageal fistulas.
- Gastrointestinal perforation, non-gastrointestinal fistulas, inflammatory bowel disease, or other bowel diseases accompanying chronic diarrhea within 6 months prior to screening.
- Current (or planned) pregnancy or breastfeeding from screening to at least 6 months following the last IP administration.
- Any condition, at the discretion of the investigator, which puts the patient at risk to participate in the study.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia3 sites, 3 recruiting
- Recruiting
Monash Medical Center
Clayton, Victoria, 3168
Amy Body
- Recruiting
Austin Hospital
Heidelberg, Victoria, 3084
Sagun Parakh
- Recruiting
Linear Clinical Research Limited
Nedlands, Western Australia, 6009
Samantha Bowyer
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Keun Wook Lee
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Seung Hoon Beom
- Recruiting
Samsung Medical Center
Seoul, 06351
Seung Tae Kim
About this study
Official title: A Phase I, Open-label, Multicenter, Dose-escalation and Dose-expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of WM-S1-030 in Patients With Advanced Solid Tumors
This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.
Read the detailed description
This is a Phase I, open-label, multicenter, dose-escalation, and dose-expansion study of WM-S1-030 in patients with advanced or metastatic solid tumors. The study will be conducted in 2 parts; a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). Part 1 will investigate oral administration of WM-S1-030 as monotherapy. Once the MTD or recommended dose is identified in Part 1, additional patients will be enrolled into Part 2 to further investigate efficacy, safety, PK, pharmacodynamics, dosing interval or schedule, and food effect on the single-dose PK of WM-S1-030.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Colorectal Cancer, Lung Cancer, Pancreatic Cancer, Cholangiocarcinoma
- Being tested
- WM-S1-030
- Medical subject headings
- Neoplasm Metastasis, Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Cholangiocarcinoma, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WM-S1-030Drug
WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| WM-S1-030 | Experimental | Dose escalation (part 1) and Dose expansion (part 2) Receives: Drug: WM-S1-030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-limiting toxicities (DLT)
Measured: During Cycle 1 in Part 1 (each cycle is 28 days)
Incidence of adverse events (AE)/serious adverse events (SAE)
Measured: From Baseline to 28 days after last dose
Secondary outcomes (9)
Maximum plasma concentration (Cmax)
Measured: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Area under the plasma concentration time curve (AUC)
Measured: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Time to maximum plasma concentration (Tmax)
Measured: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Trough plasma concentration (Ctrough)
Measured: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Elimination half-life (T1/2)
Measured: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Apparent volume of distribution during terminal phase (Vz/F)
Measured: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Accumulation ratio (Rac)
Measured: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Overall response rate (ORR) based on RECIST v1.1
Measured: Screening, Subsequent Cycles (every 8 weeks for 6 month, and then every 12 weeks up to 2 years), within 28 days after last dose (each cycle is 28 days)
Progression-free survival (PFS)
Measured: From baseline, every 12 weeks, up to within 28 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start14 Jul 2021
- Primary completion8 Aug 2025 (estimated)
- Study completion8 Aug 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
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellmarker Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801095
- Sponsor's protocol ID
- WMS1030-101
- Status last verified
- Sep 2022
- First submitted
- 4 Mar 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicenter, Dose-escalation and Dose-expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of WM-S1-030 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04801095
- Acronym / sponsor ID
- WMS1030-101
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Colorectal Cancer, Lung Cancer, Pancreatic Cancer, Cholangiocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wellmarker BioIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 8 Aug 2025 (estimated)
- Study completion
- 8 Aug 2025 (estimated)
- First posted
- 16 Mar 2021 (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 study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.
Detailed description
This is a Phase I, open-label, multicenter, dose-escalation, and dose-expansion study of WM-S1-030 in patients with advanced or metastatic solid tumors. The study will be conducted in 2 parts; a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). Part 1 will investigate oral administration of WM-S1-030 as monotherapy. Once the MTD or recommended dose is identified in Part 1, additional patients will be enrolled into Part 2 to further investigate efficacy, safety, PK, pharmacodynamics, dosing interval or schedule, and food effect on the single-dose PK of WM-S1-030.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WM-S1-030 | Experimental | Drug: WM-S1-030Dose escalation (part 1) and Dose expansion (part 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged ≥18 years.
- Able and willing to sign the informed consent form (ICF).
- Have at least 1 evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor which has progressed after treatment with standard therapies and for which no effective standard therapy is available or patient has refused, has a contraindication, or is intolerant to standard therapies.
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Key exclusion criteria (27 listed)
- Have received any prior approved or investigational treatment with RON and/or tyrosine-protein kinase Met (hepatocyte growth factor receptor) such as rilotumumab or crizotinib.
- Have received any cytotoxic chemotherapy, investigational agent (or medical device), anticancer drug, hormone therapy, or radiation therapy for treatment within 4 weeks or therapeutic radiopharmaceuticals taken within 8 weeks prior to the first administration of IP. Point (or limited) radiation to a site of bone pain, with the exception of patients receiving radiation to more than 30% of the bone marrow, will be allowed.
- Have known hypersensitivity to WM-S1-030 and/or excipient.
- Have ≥ Grade 2 unresolved toxicity related to prior anticancer therapy excluding alopecia.
- Have received drugs or herbal supplements within 2 weeks prior to the first administration of IP which are known to be inhibitors or inducers of cytochrome P450 (CYP)3A4 including, but not limited to, cannabinoids, ketoconazole, itraconazole, posaconazole, voriconazole, rifampicin, phenytoin, St. John's Wort, carbamazepine, or hyperforin.
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 |
|---|---|---|
| WM-S1-030WM-S1-030 orally administered once daily (QD) for 28 days of each cycle. | Drug | WM-S1-030 |
Primary outcome
Incidence of Dose-limiting toxicities (DLT)
Time frame: During Cycle 1 in Part 1 (each cycle is 28 days)
Incidence of adverse events (AE)/serious adverse events (SAE)
Time frame: From Baseline to 28 days after last dose
9 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Area under the plasma concentration time curve (AUC)
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Time to maximum plasma concentration (Tmax)
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Trough plasma concentration (Ctrough)
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Elimination half-life (T1/2)
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Apparent volume of distribution during terminal phase (Vz/F)
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Accumulation ratio (Rac)
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Overall response rate (ORR) based on RECIST v1.1
Time frame: Screening, Subsequent Cycles (every 8 weeks for 6 month, and then every 12 weeks up to 2 years), within 28 days after last dose (each cycle is 28 days)
Progression-free survival (PFS)
Time frame: From baseline, every 12 weeks, up to within 28 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WM-S1-030 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Wellmarker Bio at 6 sites in 2 countries.
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 27 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, South Korea. 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 Wellmarker Bio (+82-2-6952-5667, jaeyeol@wmbio.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-limiting toxicities (DLT) (time frame: During Cycle 1 in Part 1 (each cycle is 28 days)). 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?
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 16 Sep 2022.