Study of ASP1570 Alone or with Pembrolizumab in Adults with Solid Tumors

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05083481

Provider View

This clinical trial is exploring a new treatment, ASP1570, either by itself or combined with pembrolizumab, to see if it can help the immune system fight advanced solid tumors that have spread or cannot be surgically removed.

Patient Parameters

Program Overview

This study is testing a new treatment called ASP1570, which aims to help the immune system's T-cells attack cancer cells more effectively. Some tumors can resist T-cell attacks by sending 'off' signals, and ASP1570 may help turn these T-cells back on. The study involves adults with advanced solid tumors that have either spread beyond their original location or cannot be surgically removed. Participants will receive ASP1570 alone or with pembrolizumab, another cancer treatment. The study is in two parts: Part 1 will determine the best dose of ASP1570, and Part 2 will test this dose in specific cancer types like melanoma and non-small cell lung cancer (NSCLC).

Description

In this study, participants will receive ASP1570, a new treatment that may help the immune system fight cancer. Some will take ASP1570 alone, while others will take it with pembrolizumab, a drug that helps the immune system attack cancer cells. The study is divided into two parts:

  • Part 1: Different groups will try various doses of ASP1570 to find the safest and most effective dose. Participants will take ASP1570 daily in cycles of 21 days. Those in Japan will stay in the hospital for the first cycle. If no major side effects occur, the next group will try a higher dose. Participants receiving pembrolizumab will get it every six weeks.

  • Part 2: Participants will take the best dose found in Part 1. This part will focus on specific cancers like melanoma and NSCLC. Participants will continue treatment unless they experience major side effects or their cancer worsens.

After treatment, participants will have a follow-up visit 45 days after their last dose of ASP1570 or 30 days after their last dose of pembrolizumab, depending on which was last. The study team will check in with participants every 12 weeks until the study ends or they choose to leave.

Eligibility Criteria

Inclusion Criteria

  • Have advanced solid tumors that cannot be surgically removed or have spread.
  • Have at least one measurable tumor.
  • Have tried standard treatments without success or cannot have them.
  • For NSCLC participants, have no specific gene mutations and have tried a checkpoint inhibitor.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate organ function and blood counts.
  • Women must not be pregnant and agree to use contraception.
  • Men must agree to use contraception and not donate sperm.
  • Agree not to participate in another study during this one.

Exclusion Criteria

  • Have received another experimental treatment recently.
  • Need or have used steroids or immunosuppressive drugs recently.
  • Have active brain metastases or unstable brain conditions.
  • Have active autoimmune diseases, except for certain stable conditions.
  • Have a history of severe reactions to similar treatments.
  • Have certain infections like HIV or hepatitis.
  • Have had a recent heart attack or severe heart issues.
  • Have uncontrolled high blood pressure.
  • Have had another cancer in the past two years, except for certain skin or localized cancers.
  • Have had major surgery recently and not fully recovered.
  • Have a history of bleeding disorders.
  • Require anticoagulation therapy.
  • Have allergies to ASP1570 or pembrolizumab.
  • Have received high-dose lung radiation recently.

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