Clinical Trial Details

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

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Trial Information

Broad Health Condition Advanced Solid Tumor
Metastatic Solid Tumor
Colorectal Cancer
Lung Cancer
Pancreatic Cancer
Cholangiocarcinoma
Head and Neck Cancer

Specific Health Condition







Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC,WA,

Phase of TrialPhase 1

Trial summary

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

Key inclusion 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.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Wellmarker Bio

Trial websitehttps://clinicaltrials.gov/show/NCT04801095

Trial IDNCT04801095