A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07730021
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced or Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • ASP388B — DRUG
    Intravenous infusion
  • Pembrolizumab — DRUG
    Intravenous infusion
  • Carboplatin — DRUG
    Intravenous infusion
  • Oxaliplatin — DRUG
    Intravenous infusion
  • 5-fluorouracil — DRUG
    Intravenous infusion

Study Details

This is an early development study of ASP388B in people with solid tumors. In this study, ASP388B will be given to people for the first time. It will be given by itself or together with standard cancer therapies. The main aims of the study are to check the safety of ASP388B and find the most suitable dose. This study will be in 2 parts. In Part 1, different small groups of people with solid tumors will receive lower to higher doses of ASP388B. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. Any medical problems will be recorded for each dose. This is to find suitable doses of ASP388B to use in Part 2 of the study, and to include the tumor types that responded well to ASP388B. In Part 2, other different small groups of people with the specific tumor types (from Part 1) will receive the most suitable doses worked out from Part 1. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. In both parts of the study, ASP388B will be given once in 3-week cycles. The standard cancer therapies will be given according to their approved label. ASP388B and the standard cancer therapies will be given slowly through a tube into a vein. This is called an infusion. In both parts of the study, safety checks will be done at each visit, and the doctors will continue to check for medical problems throughout the study.

Key Dates

First listed
Jul 28, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2030
Completion
May 31, 2030

Study Design

Enrollment
392 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ASP388B Monotherapy Dose Escalation
    Participants with head and neck squamous cell carcinoma (HNSCC) \[including nasopharyngeal cancer (NPC)\], esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer(mCRPC), squamous non-small cell lung cancer (sqNSCLC) or small cell lung cancer (SCLC) will receive the dose based on the assigned dose level of ASP388B in 21-day cycles.
  • Experimental: ASP388B Monotherapy Dose Expansion (HNSCC)
    Participants with HNSCC excluding NPC, will receive ASP388B in 21-day cycles with dose level(s) selected from dose escalation.
  • Experimental: ASP388B Monotherapy Dose Expansion (ESCC)
    Participants with ESCC will receive ASP388B in 21-day cycles with dose level(s) selected from dose escalation.
  • Experimental: ASP388B Combination Therapy Dose Escalation (HNSCC)
    Participants with HNSCC excluding NPC and salivary gland tumors will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
  • Experimental: ASP388B Combination Therapy Dose Escalation (ESCC)
    Participants with ESCC will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
  • Experimental: ASP388B Combination Therapy Dose Expansion (HNSCC)
    Participants with HNSCC excluding NPC and salivary gland tumors will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
  • Experimental: ASP388B Combination Therapy Dose Expansion (ESCC)
    Participants with ESCC will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days after C1D1 ]

Central Contacts

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