A Study of MK-1088 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors

Phase 1

• Conditions: Treatment of advanced/metastatic solid tumors; MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502288-40-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-13
• Study Completion: 2023-09-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Has a histologically- or cytologically-confirmed diagnosis of advanced/metastatic solid tumor by pathology report and have received, have been intolerant to, or have been ineligible for treatment known to confer clinical benefit, For metastatic castrate-resistant prostate cancer (mCRPC) only: (1) Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second-generation hormonal manipulations and (2) have prostate cancer progression within 6 months before screening, as determined by the investigator, If human immunodeficiency virus (HIV) positive, has well-controlled HIV on anti-retroviral therapy (ART)

Exclusion Criteria

Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention, Has not fully recovered from any effects of major surgery without significant detectable infection, Has a history or current evidence of a gastrointestinal (GI) condition or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications, Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability, Has a QTcF >470 msec, Has history of an allogeneic stem cell transplant or a solid organ transplant, Has received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation, Has received prior radiotherapy within 2 weeks of start of study intervention, or had radiation-related toxicities requiring corticosteroids, Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention, Has a superscan bone scan, Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years, Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis, Has an active infection requiring therapy, Has a history of interstitial lung disease, Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis, Has an active autoimmune disease that has required systemic treatment in the past 2 years, Has concurrent active Hepatitis B and Hepatitis C virus infection, Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified