A Study of ASP1951 in Subjects With Advanced Solid Tumours

Official Title

A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours

Summary:

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumours; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumour effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.

Trial Description

Primary Outcome:

  • Safety and tolerability assessed by Dose Limiting Toxicity (DLT)
  • Safety and tolerability assessed by adverse events (AEs)
  • Safety and tolerability assessed by immune-related AEs (irAEs)
  • Safety and tolerability assessed by infusion-related reactions (IRRs)
  • Safety and tolerability assessed by serious adverse events (SAEs)
  • Number of participants with laboratory value abnormalities and/or adverse events related to treatment
  • Safety and tolerability assessed by 12- lead electrocardiogram (ECG)
  • Number of participants with vital signs abnormalities and/or adverse events related to treatment
  • Number of participants with Physical Exam abnormalities and/or adverse events related to treatment
  • Safety and tolerability assessed by ECOG performance status
  • Pharmacokinetics (PK) of ASP1951 in serum: AUClast
  • Pharmacokinetics (PK) of ASP1951 in serum: AUCinf
  • Pharmacokinetics (PK) of ASP1951 in serum: AUCinf%extrap
  • Pharmacokinetics (PK) of ASP1951 in serum: AUCtau
  • Pharmacokinetics (PK) of ASP1951 in serum: Cmax
  • Pharmacokinetics (PK) of ASP1951 in serum: Ctrough
  • Pharmacokinetics (PK) of ASP1951 in serum: tmax
  • Pharmacokinetics (PK) of ASP1951 in serum: t 1/2
  • Pharmacokinetics (PK) of ASP1951 in serum: tlast
  • Pharmacokinetics (PK) of ASP1951 in serum: CL
  • Pharmacokinetics (PK) of ASP1951 in serum: Vz
  • Pharmacokinetics (PK) of ASP1951 in serum: Vss
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUClast
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf%extrap
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCtau
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Cmax
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Ctrough
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tmax
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: t 1/2
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tlast
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: CL
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vz
  • Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vss
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)
  • Duration of Response (DOR) per RECIST V1.1 and iRECIST
  • Persistence of response after discontinuation per RECIST V1.1 and iRECIST
  • Disease Control Rate (DCR) per RECIST V1.1 and iRECIST
This is a dose-escalation and expansion study of ASP1951. 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 monotherapy escalation cohorts will evaluate escalating dose levels of ASP1951 in participants with locally advanced (unresectable) or metastatic solid tumour malignancies including but not limited to squamous cell carcinoma of the head and neck (SCCHN), colorectal cancer, metastatic castration-resistant prostate cancer (mCRPC) and cervical cancer. The combination escalation cohorts will evaluate escalating dose levels of ASP1951 in combination with a fixed dose of pembrolizumab. 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) (all PD-L1 status), NSCLC PDL1 high, and cervical cancer, as well as participants with any tumour types that respond to study drug treatment during dose escalation. Participants may reinitiate study drug treatment in the optional Re-treatment period after confirmation that the participant meets all the re-treatment eligibility criteria. 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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