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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04801095




Registration number
NCT04801095
Ethics application status
Date submitted
4/03/2021
Date registered
16/03/2021
Date last updated
16/09/2022

Titles & IDs
Public title
A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
WMS1030-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Colorectal Cancer 0 0
Lung Cancer 0 0
Pancreatic Cancer 0 0
Cholangiocarcinoma 0 0
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - WM-S1-030

Experimental: WM-S1-030 - Dose escalation (part 1) and Dose expansion (part 2)


Treatment: Drugs: WM-S1-030
WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose-limiting toxicities (DLT)
Timepoint [1] 0 0
During Cycle 1 in Part 1 (each cycle is 28 days)
Primary outcome [2] 0 0
Incidence of adverse events (AE)/serious adverse events (SAE)
Timepoint [2] 0 0
From Baseline to 28 days after last dose
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Secondary outcome [2] 0 0
Area under the plasma concentration time curve (AUC)
Timepoint [2] 0 0
Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Secondary outcome [3] 0 0
Time to maximum plasma concentration (Tmax)
Timepoint [3] 0 0
Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Secondary outcome [4] 0 0
Trough plasma concentration (Ctrough)
Timepoint [4] 0 0
Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Secondary outcome [5] 0 0
Elimination half-life (T1/2)
Timepoint [5] 0 0
Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Secondary outcome [6] 0 0
Apparent volume of distribution during terminal phase (Vz/F)
Timepoint [6] 0 0
Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Secondary outcome [7] 0 0
Accumulation ratio (Rac)
Timepoint [7] 0 0
Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Secondary outcome [8] 0 0
Overall response rate (ORR) based on RECIST v1.1
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Progression-free survival (PFS)
Timepoint [9] 0 0
From baseline, every 12 weeks, up to within 28 days after last dose

Eligibility
Key inclusion criteria
1. Aged =18 years.
2. Able and willing to sign the informed consent form (ICF).
3. Have at least 1 evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. 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.
5. Have Eastern Cooperative Oncology Group (ECOG) performance status =2.
6. Must have archived frozen tissue available (collected within 3 months before screening) or consent to a pre-treatment biopsy.
7. Must be willing to consent to up to 2 on-treatment biopsies.
8. Have a life expectancy of at least 12 weeks.
9. Have adequate hematological functions and blood coagulation.
10. Have adequate hepatic function at screening.
11. Have adequate renal function at screening.
12. QT interval corrected for heart rate using Fridericia's method =470 msec.
13. Agree to abide by contraception requirements.
14. Body mass index between 18 and 35 kg/m2 (exclusive)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
2. 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.
3. Have known hypersensitivity to WM-S1-030 and/or excipient.
4. Have = Grade 2 unresolved toxicity related to prior anticancer therapy excluding alopecia.
5. 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.
6. 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.
7. Have previously undergone drainage of ascites and/or pleural effusion within 4 weeks prior to screening, or have clinically significant effusions at screening.
8. Have any of the following ocular criteria:

1. Symptomatic retinal vein occlusion or central serous retinopathy defined as fluid accumulation between the retinal pigment epithelium and the outer segment of the eye
2. Symptomatic neovascular age related macular degeneration (neovascular/wet age related macular degeneration) or non proliferative diabetic retinopathy with macular edema
3. Uncontrolled glaucoma, defined as intraocular pressure >21 mmHg despite treatment or history of previous glaucoma filtration surgery
4. Presence of active intraocular inflammation, uveitis, keratitis, keratoconjunctivitis, keratopathy, corneal abrasion inflammation, or ulceration
5. Any other clinically significant risk factor for ocular disorders described above
9. 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.
10. Have serious non-healing wounds, ulcers, or bone fractures, except for traumatic fractures not requiring surgical intervention.
11. 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.
12. Have concurrent unstable or uncontrolled systemic diseases such as the following:

1. Uncontrolled hypertension despite treatment (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg)
2. 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
3. Concurrent active systemic infections requiring systemic antibiotics or antifungals (exception for management of cetuximab-related rash)
4. Active infections of hepatitis B, hepatitis C, or history of human immunodeficiency virus
5. Any other chronic disease, which, at the discretion of the investigator, could jeopardize the safety of patients or patients' compliance with the protocol.
6. Clinically significant venous thromboembolism requiring systemic anticoagulant (exception for prophylactic use)
13. Have a history of gastrointestinal or trachea-esophageal fistulas.
14. Gastrointestinal perforation, non-gastrointestinal fistulas, inflammatory bowel disease, or other bowel diseases accompanying chronic diarrhea within 6 months prior to screening.
15. Current (or planned) pregnancy or breastfeeding from screening to at least 6 months following the last IP administration.
16. Any condition, at the discretion of the investigator, which puts the patient at risk to participate in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/08/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash Medical Center - Clayton
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gyeonggi-do
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wellmarker Bio
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Covance
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.
Trial website
https://clinicaltrials.gov/study/NCT04801095
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wellmarker Bio
Address 0 0
Country 0 0
Phone 0 0
+82-2-6952-5667
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04801095