Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Adlai Nortye Biopharma Co., Ltd.
Study ID
NCT04975958
Phase
PHASE1
Status
Completed

Conditions

  • Locally Advanced Solid Tumor

Eligibility Criteria

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

Interventions

Study Details

This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors.

Key Dates

Start date
Sep 7, 2021
Status verified
Jun 2025
Primary completion
Jan 24, 2025
Completion
Jan 24, 2025

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DLT Observation Period I - AN2025 and Atezolizumab
    During the DLT Observation I, patients will be treated with AN2025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN2025 is 50 mg. If tolerated, then a subsequent cohort will escalate to 100 mg. A dose de-escalation cohort to 80 mg may occur if the 100 mg is not well tolerated. The dose of Atezolizumab will remain constant at 1200 mg every 3 weeks (Q3W) for each dose level of AN2025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
  • Experimental: DLT Observation Period II - AN0025 and Atezolizumab
    During the DLT Observation II, patients will be treated with AN0025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN0025 is 250 mg. If tolerated, then a subsequent cohort will escalate to 500 mg. If 250 mg AN0025 is not tolerated, de-escalate to 125 mg. The dose of Atezolizumab will remain constant at 1200 mg Q3W for each dose level of AN0025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
  • Experimental: DLT Observation Period III - AN2025, AN0025 and Atezolizumab
    The DLT Observation III will be started after safety data review by the investigators and the sponsor of the double combination treatments in Observations I and II. Patients enrolled in Observation III will start with the recommended dose of AN0025 from Observation II, 1200 mg Atezolizumab, and AN2025 will start from 50 mg QD. Patients will be treated with all three study drugs until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The dose of Atezolizumab will be the same (i.e., 1200 mg Q3W) regardless of dose levels of AN2025 and cohorts. Atezolizumab is administered intravenously over 60 minutes every three weeks. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. The dose of AN0025 as determined in Observation II will remain constant for each dose level of AN2025 and each cohort, unless the investigators and the sponsor determine that the toxicity comes from the AN0025 + Atezolizumab combination.

Primary Outcome Measure

Primary Outcome Measure - Dose Limiting Toxicities (DLTs) [ Time Frame: 3 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045-
Florida Cancer Specialists - Lake Mary Cancer CenterLake MaryFlorida32746-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
NYU Grossman School of MedicineNew YorkNew York10016-
Stephenson Cancer CenterOklahoma CityOklahoma73104-

Find similar trials in Aurora, CO

By research site
University of Colorado Cancer Center· Aurora, COFlorida Cancer Specialists - Lake Mary Cancer Center· Lake Mary, FLRutgers Cancer Institute of New Jersey· New Brunswick, NJNYU Grossman School of Medicine· New York, NYStephenson Cancer Center· Oklahoma City, OK

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