A Study of ASP1948, Targeting an Immune Modulatory Receptor, in Subjects With Advanced Solid Tumours

Official Title

A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumours

Summary:

The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumours; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumour effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.

Trial Description

Primary Outcome:

  • Safety and tolerability assessed by dose limiting toxicities (DLTs)
  • Safety and tolerability assessed by Adverse Events (AEs) (Initial Treatment)
  • Safety and tolerability assessed by Adverse Events (AEs) (Retreatment)
  • Safety and tolerability assessed by immune-related Adverse Events (irAEs) (Initial Treatment)
  • Safety and tolerability assessed by immune-related Adverse Events (irAEs) (Retreatment)
  • Safety and tolerability assessed by infusion-related reaction (IRRs) (Initial Treatment)
  • Safety and tolerability assessed by infusion-related reaction (IRRs) (Retreatment)
  • Safety and tolerability assessed by Serious Adverse Events (SAEs) (Initial Treatment)
  • Safety and tolerability assessed by Serious Adverse Events (SAEs) (Retreatment)
  • Number of participants with laboratory value abnormalities and/or adverse events (Initial Treatment)
  • Number of participants with laboratory value abnormalities and/or adverse events (Retreatment)
  • Safety assessed by 12- lead electrocardiogram (ECG) (Initial Treatment)
  • Safety assessed by 12- lead electrocardiogram (ECG) (Retreatment)
  • Number of participants with vital signs abnormalities and/or adverse events (Initial Treatment)
  • Number of participants with vital signs abnormalities and/or adverse events (Retreatment)
  • Number of participants with Physical Exam abnormalities and/or adverse events (Initial Treatment)
  • Number of participants with Physical Exam abnormalities and/or adverse events (Retreatment)
  • Safety assessed by Eastern Cooperative Oncology Group Performance Status (ECOG PS) (Initial Treatment)
  • Safety assessed by Eastern Cooperative Oncology Group Performance Status (ECOG PS) (Retreatment)
  • Pharmacokinetics (PK) of ASP1948 in serum: AUClast
  • Pharmacokinetics (PK) of ASP1948 in serum: AUCinf
  • Pharmacokinetics (PK) of ASP1948 in serum: AUCinf %extrap
  • Pharmacokinetics (PK) of ASP1948 in serum: AUCtau
  • Pharmacokinetics (PK) of ASP1948 in serum: Cmax
  • Pharmacokinetics (PK) of ASP1948 in serum: Ctrough
  • Pharmacokinetics (PK) of ASP1948 in serum: tmax
  • Pharmacokinetics (PK) of ASP1948 in serum: t1/2
  • Pharmacokinetics (PK) of ASP1948 in serum: tlast
  • Pharmacokinetics (PK) of ASP1948 in serum: CL
  • Pharmacokinetics (PK) of ASP1948 in serum: V
Secondary Outcome:
  • Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumours (RECIST) V1.1 and modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Initial Treatment)
  • Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumours (RECIST) V1.1 and modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Retreatment)
  • Duration of Response (DOR) per RECIST V1.1 and iRECIST (Initial Treatment)
  • Duration of Response (DOR) per RECIST V1.1 and iRECIST (Retreatment)
  • Persistence of response after discontinuation per RECIST V1.1 and iRECIST (Initial Treatment)
  • Persistence of response after discontinuation per RECIST V1.1 and iRECIST (Retreatment)
  • Disease Control Rate (DCR) per RECIST V1.1 and iRECIST (Initial Treatment)
  • Disease Control Rate (DCR) per RECIST V1.1 and iRECIST (Retreatment)
This is a dose-escalation and expansion study of ASP1948 as a single agent and in combination with nivolumab or pembrolizumab. The study consists of 3 periods for monotherapy and combination therapy: screening, treatment and follow up, followed by an optional Re-treatment period for participants that qualify. The escalation cohorts will evaluate escalating dose levels of ASP1948 in participants with locally advanced (unresectable) or metastatic solid tumour malignancies. After discontinuation of study drug, all participants will complete an end-of-treatment visit, along with 30-day and 90-day safety follow-up visits from the last dose of study drug. For dose expansion, the tumour-specific cohorts will include participants with squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (mCRPC), ovarian cancer, pancreatic cancer and breast cancer, as well as any tumour types that respond to study drug treatment during dose escalation.

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