Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumours

Official Title

A Phase 1, Multicentre, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects With Advanced Solid Tumours

Summary:

The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumours.

Trial Description

Primary Outcome:

  • Number of Participants with Dose Limiting Toxicities (DLTs)
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)
  • Number of Participants with Treatment-Related Adverse Events
  • Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurements
  • Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Results
  • Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Secondary Outcome:
  • Objective Response (OR)
  • Duration of Response (DOR)
  • Overall Survival (OS)
  • Progression-Free Survival (PFS)
  • Time to Progression
  • Time to Subsequent Therapy
  • Maximum Observed Serum Concentration (Cmax) of AMG 994
  • Maximum Observed Serum Concentration (Cmax) of AMG 404
  • Minimum Observed Serum Concentration (Cmin) of AMG 994
  • Minimum Observed Serum Concentration (Cmin) of AMG 404
  • Area Under the Serum Concentration-time Curve (AUC) of AMG 994
  • Area Under the Serum Concentration-time Curve (AUC) of AMG 404
  • Half-life (t1/2) of AMG 994
  • Half-life (t1/2) of AMG 404
AMG 994 will be administered by short term intravenous (IV) infusion once weekly in each 28-day cycle and AMG 404 will be administered by short-term IV infusion once every 4 weeks (Q4W) in a 28 day cycle (on day 1 of cycle 2 and beyond). The study will be conducted in 2 parts: Part 1
  • Dose Exploration and Part 2
  • Dose Expansion.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society