A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors

Summary

Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on.

Before a treatment can be approved for use, clinical studies need to be done. This study will provide more information on ASP1570 in adults with advanced solid tumors. ASP1570 will either be given by itself, or given with another medicine called pembrolizumab, given with a standard cancer therapy, or given together with pembrolizumab and other medicines called pemetrexed and carboplatin.

The main aims of this study are：

* To check the safety of ASP1570
* To check how well ASP1570 is tolerated
* To find a suitable dose of ASP1570

This study is for adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. The study doctors can give more advice about who can take part.

This study will be in 2 parts.

In Part 1, the most suitable dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570. People will either be given ASP1570 by itself, or ASP1570 with pembrolizumab, ASP1570 with a standard cancer therapy, or ASP1570 with pembrolizumab, pemetrexed and carboplatin. The study treatment given depends on the type of cancer people have. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 standard dose of pembrolizumab. The dose of a standard cancer therapy depends on its label. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group tolerates the lowest dose. This will continue in the same way for each group.

Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People will continue with more treatment cycles on the same dose unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment. People who also receive treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). People who are receiving a standard cancer therapy (with ASP1570) will be treated according to its label.

In Part 2, different small groups of people with advanced solid tumors will take the most suitable dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people could tolerate from Part 1. ASP1570 will be given either once a day or twice a day in a 21-day cycle. Pembrolizumab will be given once every 6 weeks. Other study treatments will be given in 14-day, 21-day or 28-day cycles. The cycle length and other study treatments given (pembrolizumab and the type of standard cancer therapy will depend on what type of tumor people have. The standard cancer therapies will be given according to their label. All groups will continue with more treatment cycles with ASP1570 (by itself with pembrolizumab, with a standard cancer therapy, or with pembrolizumab, pemetrexed and carboplatin) unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment.

Conditions

• Advanced Solid Tumors

Interventions

DRUG

5-Fluorouracil

Intravenous Infusion

DRUG

Irinotecan

Intravenous Infusion

DRUG

Pemetrexed

Intravenous Infusion

DRUG

Carboplatin

Intravenous Infusion

DRUG

pembrolizumab

Intravenous Infusion

DRUG

Trifluridine + Tipiracil

Oral Administration

DRUG

Bevacizumab

Intravenous Infusion

DRUG

Docetaxel

Intravenous Infusion

DRUG

Oxaliplatin

Intravenous Infusion

DRUG

Leucovorin

Intravenous Infusion

DRUG

ASP1570

Oral tablet

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Astellas Pharma Global Development, Inc.

  lead INDUSTRY

Principal Investigators

• Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-19

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States
• China
• France
• Japan
• Puerto Rico
• Spain

Study Locations