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

Trial ID: NCT04801095

Interventional - Phase 1 - Unknown status

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

Conditions

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

Interventions

• WM-S1-030

Eligibility

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.

Exclusion criteria

• 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.
• 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.
• Have previously undergone drainage of ascites and/or pleural effusion within 4 weeks prior to screening, or have clinically significant effusions at screening.
• 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.
• 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.
• Have concurrent unstable or uncontrolled systemic diseases.
• Have a history of gastrointestinal or trachea-esophageal fistulas.
• Current (or planned) pregnancy or breastfeeding from screening to at least 3 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.

Sponsor

Wellmarker Bio

Source: Clinicaltrials.gov

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