ClinicalTrials.gov

History of Changes for Study: NCT04801095
A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors
Latest version (submitted September 15, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 14, 2021 None (earliest Version on record)
2 August 6, 2021 Recruitment Status, Study Status, Contacts/Locations and Eligibility
3 September 15, 2022 Contacts/Locations, Study Status and Eligibility
Comparison Format:

Scroll up to access the controls

Study NCT04801095
Submitted Date:  March 14, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: WMS1030-101
Brief Title: A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Not yet recruiting
Study Start: April 1, 2021
Primary Completion: August 8, 2025 [Anticipated]
Study Completion: August 8, 2025 [Anticipated]
First Submitted: March 4, 2021
First Submitted that
Met QC Criteria:
March 14, 2021
First Posted: March 16, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 14, 2021
Last Update Posted: March 16, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Wellmarker Bio
Responsible Party: Sponsor
Collaborators: Covance
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Colorectal Cancer
Lung Cancer
Pancreatic Cancer
Cholangiocarcinoma
Head and Neck Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: WM-S1-030
Dose escalation (part 1) and Dose expansion (part 2)
Drug: WM-S1-030
WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Dose-limiting toxicities (DLT)
[ Time Frame: During Cycle 1 in Part 1 (each cycle is 28 days) ]

2. Incidence of adverse events (AE)/serious adverse events (SAE)
[ Time Frame: From Baseline to 28 days after last dose ]

Secondary Outcome Measures:
1. Maximum plasma concentration (Cmax)
[ Time Frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days) ]

2. 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) ]

3. Time to maximum plasma concentration (Tmax)
[ Time Frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days) ]

4. Trough plasma concentration (Ctrough)
[ Time Frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days) ]

5. Elimination half-life (T1/2)
[ Time Frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days) ]

6. 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) ]

7. Accumulation ratio (Rac)
[ Time Frame: Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days) ]

8. 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) ]

9. Progression-free survival (PFS)
[ Time Frame: From baseline, every 12 weeks, up to within 28 days after last dose ]

Other Outcome Measures:
1. 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) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.

Exclusion Criteria:

  1. 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.
  2. Have known hypersensitivity to WM-S1-030 and/or excipient.
  3. Have ≥ Grade 2 unresolved toxicity related to prior anticancer therapy excluding alopecia.
  4. 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.
  5. Have any primary central nervous system (CNS) tumors or known CNS metastases unless clinically stable.
  6. Have previously undergone drainage of ascites and/or pleural effusion within 4 weeks prior to screening, or have clinically significant effusions at screening.
  7. 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.
  8. Have serious non-healing wounds, ulcers, or bone fractures, except for traumatic fractures not requiring surgical intervention.
  9. Have an active infection treated with systemic anti-infectives within 2 weeks of Cycle 1 Day 1.
  10. Have concurrent unstable or uncontrolled systemic diseases.
  11. Have a history of gastrointestinal or trachea-esophageal fistulas.
  12. Current (or planned) pregnancy or breastfeeding from screening to at least 3 months following the last IP administration.
  13. Any condition, at the discretion of the investigator, which puts the patient at risk to participate in the study.
Open or close this module Contacts/Locations
Central Contact Person: Wellmarker Bio
Telephone: +82-2-6952-5662
Email: nkim@wmbio.co
Locations: Australia, Victoria
Monash Medical Center
Clayton, Victoria, Australia, 3168
Contact:Principal Investigator: Sophia Fentzas
Australia, Western Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia, 6009
Contact:Principal Investigator: Samantha Bowyer
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services