A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Amgen
Study ID
NCT06131398
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • AMG 355 — DRUG
    Short-term intravenous (IV) infusion
  • Pembrolizumab — DRUG
    Short-term IV infusion

Study Details

The primary objectives of this study are to: * Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors * Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.

Key Dates

Start date
Mar 7, 2024
Status verified
May 2026
Primary completion
Jul 21, 2026
Completion
Jul 21, 2026

Study Design

Enrollment
77 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group A: AMG 355 monotherapy
    Specified dose on specified days
  • Experimental: Group B: AMG 355 and pembrolizumab
    Specified dose on specified days

Primary Outcome Measure

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Day 1 to Day 21 ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Alliance for Multispecialty Research - Kansas CityMerriamKansas66204-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Washington UniversitySt LouisMissouri63110-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAAlliance for Multispecialty Research - Kansas City· Merriam, KSDana-Farber Cancer Institute· Boston, MAWashington University· St Louis, MOWake Forest University Health Sciences· Winston-Salem, NCSouth Texas Accelerated Research Therapeutics· San Antonio, TX

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