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A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04801095
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : September 16, 2022
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Wellmarker Bio

Tracking Information
First Submitted Date  ICMJE March 4, 2021
First Posted Date  ICMJE March 16, 2021
Last Update Posted Date September 16, 2022
Actual Study Start Date  ICMJE July 14, 2021
Estimated Primary Completion Date August 8, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2021)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 14, 2021)
Predictive biomarker analyses for genotyping mutation [ Time Frame: Screening, Subsequent Cycles up to 2 years, within 28 days after last dose (each cycle is 28 days) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Colorectal Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Cholangiocarcinoma
  • Head and Neck Cancer
Intervention  ICMJE Drug: WM-S1-030
WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.
Study Arms  ICMJE Experimental: WM-S1-030
Dose escalation (part 1) and Dose expansion (part 2)
Intervention: Drug: WM-S1-030
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 8, 2025
Estimated Primary Completion Date August 8, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wellmarker Bio +82-2-6952-5667 jaeyeol@wmbio.co
Listed Location Countries  ICMJE Australia,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04801095
Other Study ID Numbers  ICMJE WMS1030-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wellmarker Bio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Wellmarker Bio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Covance
Investigators  ICMJE Not Provided
PRS Account Wellmarker Bio
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP