A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as… (NCT03829501) | Clinical Trial Compass
TerminatedPhase 1/2
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
Stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
United States222 participantsStarted 2019-01-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Phase 1: Participants with advanced/metastatic malignancies, and preferred indications (non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, cervical, esophageal, gastric, renal, pancreatic, and triple negative breast cancer)
✓. Phase 2 Alomfilimab single agent: Participants with advanced/metastatic malignancies in indications in which signs of anti-tumor activity (Complete Response (CR), Partial Response (PR) or durable stable disease (SD) with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of Alomfilimab as single agent
✓. Phase 2 Alomfilimab in combination with atezolizumab: Participants with advanced/metastatic malignancies in the selected indications below, and/or indications which have shown promising activity in Phase 1:
Exclusion criteria
✕. Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association \[NYHA\] Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia
✕. QTcF \>470 msec on screening (electrocardiogram) ECG using Fridericia's formula (QTcF) or congenital long QT syndrome
✕
What they're measuring
1
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: 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
2
Phase 1: Number of Participants Experiencing Dose Changes
Timeframe: 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
3
Phase 1: Absolute Dose Intensity
Timeframe: 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
4
Phase 1: Relative Dose Intensity
Timeframe: 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
5
Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Timeframe: From first dose of study treatment (Day 1) up to 21 days
6
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks