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  • Cancer Type: Thoracic
  • Study Type: Treatment
  • NCT#: NCT05067283
  • Phase: Phase I
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  • Overview

    Study Title:

    A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and in Combination with Pembrolizumab in Subjects with KRASG12C Mutant Advanced Solid Tumors

    Summary:

    This is a study evaluating the efficacy, safety, and pharmacokinetics of MK-1084 in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRASG12C) mutation and MK-1084 plus pembrolizumab in participants with first line (1L) non-small cell lung cancer (NSCLSC) with identified KRASG12C mutation.

    Objective:

    Primary: * To determine safety and tolerability of MK-1084 in monotherapy and in combination with pembrolizumab Secondary: * To evaluate objective response rate (ORR) of participants treated with MK-1084 as monotherapy and in combination with pembrolizumab using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator * To evaluate duration of response (DOR) of participants treated with MK-1084 as monotherapy and in combination with pembrolizumab per RECIST 1.1 as assessed by the investigator * To evaluate MK-1084 pharmacokinetics (PK) in monotherapy and in combination with pembrolizumab

  • Treatments

    Therapies:

    Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

    Medications:

    Alimta (Pemetrexed); MK-1084 (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); carboplatin ()

  • Inclusion Criteria

    • For all participants:
    • Has measurable disease by RECIST 1.1 criteria.
    • Has adequate organ function.
    • Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic.
    • Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention.
    • For Arm 1:
    • Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
    • For Arm 2:
    • Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
    • For Arm 3:
    • Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 3L/4L metastatic colorectal cancer (mCRC)
    • Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation
    • Previous treatment failure of 2 or 3 previous lines of systemic therapy Expansion Group B
    • Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
    • Arm 4 only:
    • Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
    • Arm 5 only:
    • Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
    • Previous treatment failure of one or 2 previous line(s) of systemic therapy
    • Arm 6 only:
    • Untreated locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
  • Exclusion Criteria

    • Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation).
    • Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years.
    • Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis.
    • Has an active infection requiring systemic therapy.
    • Has a history of human immunodeficiency virus (HIV) and/or hepatitis B or C infections.
    • Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
    • Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis.
    • Has an active autoimmune disease requiring systemic therapy.
    • Has not fully recovered from any effects of major surgical procedure without significant detectable infection.
    • Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease.
    • Has received live or live-attenuated vaccine within 4 weeks of study start.

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