Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single-Agent or in Combination in Advanced Solid Tumors

    Cancer Categories
    • Gastrointestinal (GI),Head and Neck
    Karmanos Trial ID
    • 2024-100
    NCT ID
    • NCT03526835
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Mohammed Najeeb
      Al Hallak, M.D., MS

      Oncology - Medical View Profile

    Objective:

    Dose escalation (completed)

    Primary Objective:

    • To determine the preliminary RP2D of single-agent petosemtamab in mCRC patients who have progressed on chemotherapy, with or without an anti-VEGF therapy, and with an anti-EGFR therapy (if RAS WT)

    Secondary Objectives:

    • To characterize the safety and tolerability of petosemtamab
    • To evaluate preliminary antitumor activity
    • To characterize the PK of petosemtamab
    • To characterize the immunogenicity of petosemtamab

    Dose expansion (single-agent nonrandomized early expansion, 2L/3L HNSCC, 3L+ mCRC, and esophageal cohorts)

    Primary Objective:

    • To determine the ORR per RECIST v1.1 as assessed by investigator review

    Secondary Objectives:

    • To further evaluate antitumor activity per RECIST v1.1 as assessed by investigator review
    • For 3L+ mCRC only: To evaluate antitumor activity per RECIST v1.1 as assessed by blinded independent central review (BICR)
    • To evaluate overall survival (OS) (Note: this is an exploratory objective for the esophageal cohort)
    • To characterize safety and tolerability of single-agent petosemtamab
    • To characterize the PK of petosemtamab
    • To characterize the immunogenicity of petosemtamab

    Dose expansion (single-agent, randomized expansion in 2L/3L HNSCC cohort)

    Primary Objectives:

    • To descriptively characterize all relevant clinical safety and efficacy data
    • To characterize the exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg Q2W in terms of TEAEs

    Secondary Objectives:

    • To characterize the exposure-efficacy relationship of petosemtamab administered at 1100 mg and 1500 mg Q2W in terms of the sum of the diameters of target lesions
    • To characterize the exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg Q2W in terms of Grades 3-4 TEAEs, IRRs, and nonIRR TEAEs
    • To evaluate antitumor activity per RECIST v1.1 as assessed by investigator review
    • To characterize other safety endpoints of 1100 mg and 1500 mg Q2W dose of single-agent petosemtamab
    • To characterize the PK of petosemtamab
    • To characterize the immunogenicity of petosemtamab

    Dose expansion (combination with pembrolizumab [1L HNSCC], FOLFIRI [mCRC], or FOLFOX [mCRC] cohorts)

    Primary Objectives:

    • To determine the ORR per RECIST v1.1 as assessed by investigator review
    • To characterize safety of petosemtamab combination therapies

    Secondary Objectives:

    • To further evaluate antitumor activity per RECIST v1.1 as assessed by investigator review
    • For mCRC combination cohorts only: To evaluate antitumor activity per RECIST v1.1 as assessed by BICR
    • To characterize other safety endpoints and tolerability of petosemtamab combination therapies
    • To characterize the PK of petosemtamab when administered as combination therapy
    • To characterize the immunogenicity of petosemtamab when administered as combination therapy
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
    Get Directions