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

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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

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 Phase

Phase 1

Study Type


Primary Outcome

Incidence of Dose-limiting toxicities (DLT)

Secondary Outcome

 Maximum plasma concentration (Cmax)


Advanced Solid Tumor



Study Arms / Comparison Groups

Description:  Dose escalation (part 1) and Dose expansion (part 2)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 14, 2021

Completion Date

August 8, 2025

Primary Completion Date

August 8, 2025

Eligibility 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.

         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

          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

          3. Have known hypersensitivity to WM-S1-030 and/or excipient.

          4. Have ≥ Grade 2 unresolved toxicity related to prior anticancer therapy excluding

          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

          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

               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.




18 Years - N/A

Accepts Healthy Volunteers



, +82-2-6952-5667, [email protected]

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Responsible Party


Study Sponsor

Wellmarker Bio



Study Sponsor

, , 

Verification Date

September 2022