A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)

Part of paid clinical trials in Orange, California.

Sponsor
Amgen
Study ID
NCT05267470
Phase
PHASE1
Status
Terminated

Conditions

  • Squamous-Cell Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Bemarituzumab — DRUG
    Intravenous (IV) infusion
  • Docetaxel — DRUG
    IV infusion
  • Pembrolizumab — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion
  • Nab-paclitaxel — DRUG
    IV infusion

Study Details

The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.

Key Dates

Start date
Mar 29, 2022
Status verified
Feb 2025
Primary completion
May 28, 2024
Completion
May 28, 2024

Study Design

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

Arms

  • Experimental: Part 1: Combination Dose Exploration
    Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel.
  • Experimental: Part 2: Combination Dose Expansion
    Participants with SqNSCLC and FGFR2b overexpression will receive the dose of bemarituzumab in combination with docetaxel identified as safe during Part 1.
  • Experimental: Part 3: Bemarituzumab Monotherapy
    Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy.
  • Experimental: Part 4: Combination Immuno-chemotherapy
    Participants with FGFR2b overexpression will receive the dose of bemarituzumab identified as safe during Part 1 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel.

Primary Outcome Measure

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4 [ Time Frame: Day 1 to Day 21 of Cycle 1 (each cycle was 21 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868-
Morristown Medical CenterMorristownNew Jersey07960-
Montefiore Einstein Center for Cancer CareThe BronxNew York10461-
University of Pittsburgh, Cancer InstitutePittsburghPennsylvania15211-

Related coverage on Hipa.ai

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By research site
University of California Irvine· Orange, CAMorristown Medical Center· Morristown, NJMontefiore Einstein Center for Cancer Care· The Bronx, NYUniversity of Pittsburgh, Cancer Institute· Pittsburgh, PA