Study of WM-A1-3389 in Participants With Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer (MK-3475-E90/KEYNOTE-E90)

NCT05872867 | Recruiting Phase 1

• 3 other identifiers: WMA13389-101MK-3475-E90KEYNOTE-E90
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the present study is to determine the safety, tolerability, and efficacy of WM-A1-3389 in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancer (NSCLC).

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor; Lung Cancer; Colorectal Cancer; Pancreatic Cancer; Cholangiocarcinoma; Head and Neck Cancer; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Incidence of Dose Limit Toxicities (DLT)

  At the end of Cycle 1 (each cycle is 21 days)

• Number of Participants Who Experienced an Adverse Event (AE)

  Up to 6 Cycles (18 weeks)

• Frequency of dose discontinuation and dose reduction due to ADRs

  Up to 6 Cycles (18 weeks)

Secondary Outcomes (25)

• Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumor (RECIST) v1.1

  Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

• Disease control rate (DCR) based on RECIST v1.1

  Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

• Disease control rate (DCR) based on Immune RECIST (iRECIST)

  Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

• Duration of response (DOR) based on RECIST v1.1

  Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

• Duration of response (DOR) based on iRECIST

  Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)

Study Arms (2)

Dose escalation (Stage 1)

EXPERIMENTAL

WM-A1-3389 administered intravenously, weekly for 21 days of each cycle

Biological: WM-A1-3389

Dose escalation (Stage 2)

EXPERIMENTAL

WM-A1-3389 administered intravenously, weekly for 21 days of each cycle Pembrolizumab 200 mg administered intravenously, every 3 weeks for 21 days of each cycle

Biological: WM-A1-3389; Biological: Pembrolizumab

Interventions

WM-A1-3389 BIOLOGICAL

Anti-IGSF1 (Immunoglobulin superfamily member 1)

Dose escalation (Stage 1); Dose escalation (Stage 2)

Pembrolizumab BIOLOGICAL

Anti-PD-1(Programmed cell death protein 1)

Also known as: KEYTRUDA®

Dose escalation (Stage 2)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Stage 1: monotherapy\]
• Be ≥19 and \<75 years of age
• Participant with histologically and/or cytologically confirmed diagnosis of unresectable advanced or metastatic solid tumors that have been confirmed as progressed disease after standard of care or for which no further standard therapy is available due to intolerance or incompatibility
• IGSF1 positive expression
• Have measurable disease defined as at least one lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have life expectancy ≥ 12 weeks
• Have adequate organ functions defined as the following laboratory test criteria at screening (During the screening phase, one re-test will be permitted):
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Hemoglobin (Hb) ≥ 9 g/dL
• Total bilirubin ≤ 1.5 X Institutional Upper Limit of Normal (IULN) (Not applicable to patients with Gilbert syndrome)
• Serum creatinine ≤ 1.5 X IULN
• Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) ≤ 2.5 X IULN (AST and ALT ≤ 5 X IULN in patients with confirmed liver metastasis)
• Prothrombin time (PT) ≤ 1.5 X IULN \*IULN: Institutional Upper Limit of Normal

You may not qualify if:

• \[Common\]
• Have experienced hypersensitivity to IP, any of its excipients or other monoclonal antibody
• Have any of the following documented medical history or surgical/procedure history:
• Other primary malignant tumor (subject may be enrolled if they have neither received any treatment nor experienced disease progression within 3 years) or hematologic malignancy
• Major surgery within 4 weeks or minor surgery within 2 weeks prior to IP administration
• Clinically significant arrhythmia, acute myocardial infarction, unstable angina pectoris, or New York Heart Association (NYHA) class Ⅲ or Ⅳ heart failure within 6 months prior to IP administration
• Severe cerebrovascular disease within 6 months prior to IP administration
• Pulmonary thrombosis, deep vein thrombosis, bronchial asthma, obstructive pulmonary disease, or other severe or life-threatening lung diseases (e.g., acute respiratory distress syndrome, lung failure) considered to be inappropriate for study participationt, within 6 months prior to IP administration
• Pneumonia or interstitial lung disease requiring steroids
• f. Infection requiring systemic antibiotics or antiviral agents, etc. or uncontorlled Grade ≥ 3 active infectious diseases within 2 weeks prior to IP administration g. Risk factors of ileus or intestinal perforation (including but not limited to history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis) h. Auto-immune diseases
• Have any of the following diseases:
• Central nervous system or brain metastasis that is uncontrolled or with clinically significant symptoms (except for patients who stopped systemic corticosteroids at least 4 weeks before IP administration and have been stable for at least 4 weeks)
• Abnormal ECG regarded as clinically significant by the investigator
• Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 160 mmHg or diastolic blood pressure \[DBP\] \> 100 mmHg)
• Active infection requiring treatment

Sponsors & Collaborators

• Wellmarker Bio: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Seoul St. Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

RECRUITING

Incheon St. Mary's Hospital

Incheon, Yeonsu-gu, 21999, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Lung Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Cholangiocarcinoma; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wellmarker BIO

CONTACT

+82-2-6933-5667; selee@wmbio.co

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 24, 2023
• Study Start: March 14, 2024
• Primary Completion: February 22, 2026
• Study Completion: February 22, 2026
• Last Updated: March 12, 2024

Record last verified: 2023-10

Locations

KR (2)