A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Genentech, Inc.
Study ID
NCT03448042
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Runimotamab — DRUG
    Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
  • Trastuzumab — DRUG
    Trastuzumab will be administered via IV infusion
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab if needed

Study Details

This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

Key Dates

First listed
Feb 27, 2018
Start date
Jun 6, 2018
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
123 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
  • Experimental: Dose Expansion
    Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.

Primary Outcome Measure

Percentage of Participants with Adverse Events [ Time Frame: From baseline through end of study (approximately 78 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511-
Washington UniversitySaint LouisMichigan63130-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10017-
SCRI Oncology PartnersNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTWashington University· Saint Louis, MIMemorial Sloan Kettering Cancer Center· New York, NYSCRI Oncology Partners· Nashville, TNMD Anderson Cancer Center· Houston, TX

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