A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Kymab Limited
Study ID
NCT03829501
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Alomfilimab — DRUG
    A human anti-ICOS monoclonal antibody
  • Atezolizumab — DRUG
    An anti-PD-L1 monoclonal antibody

Study Details

A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.

Key Dates

Start date
Jan 28, 2019
Status verified
Mar 2025
Primary completion
Oct 3, 2024
Completion
Oct 3, 2024

Study Design

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

Arms

  • Experimental: Phase 1: Alomfilimab Monotherapy
    Participants will receive alomfilimab 0.8 to 240 mg as a single agent via intravenous (IV) infusion every 3 weeks (Q3W).
  • Experimental: Phase 1: Alomfilimab + Atezolizumab Combination Therapy
    Participants will receive alomfilimab 2.4 to 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.
  • Experimental: Phase 2: Alomfilimab + Atezolizumab in Anti-PD-(L)1 Naïve Participants
    Anti-PD-(L)1 naïve participants with pancreatic cancer, triple negative breast cancer (BC) or head and neck squamous cell carcinoma (HNSCC) will receive alomfilimab 2.4 to 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.
  • Experimental: Phase 2: Alomfilimab + Atezolizumab in Pre-treated Participants
    Pre-treated participants with pancreatic cancer, triple negative BC or HNSCC will receive alomfilimab 2.4 to 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.

Primary Outcome Measure

Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Kymab investigational site 1109DuarteCalifornia91010-
Kymab investigational site 1102New HavenConnecticut06510-
Kymab investigational site 1108OrlandoFlorida32806-
Kymab investigational site 1104SarasotaFlorida34232-
Kymab investigational site 1103NashvilleTennessee37203-
Kymab investigator site 1101HoustonTexas77030-

Related coverage on Hipa.ai

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