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

PHASE1RECRUITING

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

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Aged ≥18 years.

Able and willing to sign the informed consent form (ICF).

Have at least 1 evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

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.

Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

Must have archived frozen tissue available (collected within 3 months before screening) or consent to a pre-treatment biopsy.

Must be willing to consent to up to 2 on-treatment biopsies.

Have a life expectancy of at least 12 weeks.

Have adequate hematological functions and blood coagulation.

Have adequate hepatic function at screening.

Have adequate renal function at screening.

QT interval corrected for heart rate using Fridericia's method ≤470 msec.

Agree to abide by contraception requirements.

Body mass index between 18 and 35 kg/m2 (exclusive)

Exclusion criteria

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.

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.

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

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

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.

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.

Have previously undergone drainage of ascites and/or pleural effusion within 4 weeks prior to screening, or have clinically significant effusions at screening.

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

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.

Have serious non-healing wounds, ulcers, or bone fractures, except for traumatic fractures not requiring surgical intervention.

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.

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)

Have a history of gastrointestinal or trachea-esophageal fistulas.

Gastrointestinal perforation, non-gastrointestinal fistulas, inflammatory bowel disease, or other bowel diseases accompanying chronic diarrhea within 6 months prior to screening.

Current (or planned) pregnancy or breastfeeding from screening to at least 6 months following the last IP administration.

Any condition, at the discretion of the investigator, which puts the patient at risk to participate in the study.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-07-14

Primary completion: 2025-08-08

Study completion finish: 2025-08-08

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT04801095

Intervention or treatment

DRUG: WM-S1-030

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Colorectal Cancer
• Lung Cancer
• Pancreatic Cancer
• Cholangiocarcinoma
• Head and Neck Cancer

Condition: Advanced Solid Tumor, Metastatic Solid Tumor and more
DRUG: WM-S1-030
Heidelberg, Victoria, Australia and more
Sponsor: Wellmarker Bio

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Hospital

Research sites nearby

Select from list below to view details:

Austin Hospital
Heidelberg, Victoria, Australia
Monash Medical Center
Clayton, Victoria, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of Dose-limiting toxicities (DLT)	Not Specified	During Cycle 1 in Part 1 (each cycle is 28 days)
Incidence of adverse events (AE)/serious adverse events (SAE)	Not Specified	From Baseline to 28 days after last dose

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Maximum plasma concentration (Cmax)	Not Specified	Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Area under the plasma concentration time curve (AUC)	Not Specified	Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Time to maximum plasma concentration (Tmax)	Not Specified	Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Trough plasma concentration (Ctrough)	Not Specified	Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Elimination half-life (T1/2)	Not Specified	Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Apparent volume of distribution during terminal phase (Vz/F)	Not Specified	Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Accumulation ratio (Rac)	Not Specified	Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)
Overall response rate (ORR) based on RECIST v1.1	Not Specified	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)
Progression-free survival (PFS)	Not Specified	From baseline, every 12 weeks, up to within 28 days after last dose

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Connect to trial

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors