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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 : August 9, 2021
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Wellmarker Bio

Brief Summary:
This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Metastatic Solid Tumor Colorectal Cancer Lung Cancer Pancreatic Cancer Cholangiocarcinoma Head and Neck Cancer Drug: WM-S1-030 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : August 8, 2025
Estimated Study Completion Date : August 8, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 prior to the first administration of IP.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801095


Contacts
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Contact: Wellmarker Bio +82-2-6952-5662 nkim@wmbio.co

Locations
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Australia, Victoria
Monash Medical Center Recruiting
Clayton, Victoria, Australia, 3168
Principal Investigator: Sophia Fentzas         
Australia, Western Australia
Linear Clinical Research Limited Recruiting
Nedlands, Western Australia, Australia, 6009
Principal Investigator: Samantha Bowyer         
Sponsors and Collaborators
Wellmarker Bio
Covance
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Responsible Party: Wellmarker Bio
ClinicalTrials.gov Identifier: NCT04801095    
Other Study ID Numbers: WMS1030-101
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type