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Closed (no longer recruiting)Last updated: 3 May 2024

WM-S1-030: This Phase I trial is evaluating how safe and tolerable a targeted therapy drug (WM-S1-030) is in people with advanced solid cancersA 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

Clinical summary

Summary

This trial has one experimental arm broken into two parts. In Part 1 (dose escalation), participants will receive WM-S1-030 orally by itself. Once the MTD or recommended dose is identified in Part 1, additional participants will be enrolled into Part 2 (dose expansion) to further investigate efficacy, safety and pharmacodynamics, dosing interval or schedule, and food effect on the single dose PK of WM-S1-030. WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

WM-S1-030

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Wellmarker Bio

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

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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