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

NCT04801095 | Unknown Phase 1

• 1 other identifier: WMS1030-101
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-limiting toxicities (DLT)

  During Cycle 1 in Part 1 (each cycle is 28 days)

• Incidence of adverse events (AE)/serious adverse events (SAE)

  From Baseline to 28 days after last dose

Secondary Outcomes (9)

• Maximum plasma concentration (Cmax)

  Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)

• Area under the plasma concentration time curve (AUC)

  Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)

• Time to maximum plasma concentration (Tmax)

  Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)

• Trough plasma concentration (Ctrough)

  Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)

• Elimination half-life (T1/2)

  Cycle 1, Cycle 2, Subsequent Cycles up to 2 years (each cycle is 28 days)

Other Outcomes (1)

• Predictive biomarker analyses for genotyping mutation

  Screening, Subsequent Cycles up to 2 years, within 28 days after last dose (each cycle is 28 days)

Study Arms (1)

WM-S1-030

EXPERIMENTAL

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

Drug: WM-S1-030

Interventions

WM-S1-030 DRUG

WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.

WM-S1-030

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• Symptomatic retinal vein occlusion or central serous retinopathy defined as fluid accumulation between the retinal pigment epithelium and the outer segment of the eye
• Symptomatic neovascular age related macular degeneration (neovascular/wet age related macular degeneration) or non proliferative diabetic retinopathy with macular edema
• Uncontrolled glaucoma, defined as intraocular pressure \>21 mmHg despite treatment or history of previous glaucoma filtration surgery
• Presence of active intraocular inflammation, uveitis, keratitis, keratoconjunctivitis, keratopathy, corneal abrasion inflammation, or ulceration
• 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.

Sponsors & Collaborators

• Wellmarker Bio: lead
• Covance: collaborator

Study Sites (6)

Monash Medical Center

Clayton, Victoria, 3168, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

RECRUITING

Linear Clinical Research Limited

Nedlands, Western Australia, 6009, Australia

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Colorectal Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Cholangiocarcinoma; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Wellmarker Bio

CONTACT

+82-2-6952-5667; jaeyeol@wmbio.co

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 16, 2021
• Study Start: July 14, 2021
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

KR (3); AU (3)