ASP2074 for Solid Tumors

No longer recruiting at 13 trial locations

Overseen By Astellas Pharma Global Development, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS metastases, Active autoimmune, HIV, Hepatitis, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ASP2074 for individuals with certain solid tumors that have spread or are in advanced stages. The goal is to determine a safe and effective dose and to identify any side effects. The trial targets those who have exhausted all available standard treatments for their cancer without benefit. Participants should have a diagnosis of colorectal, pancreatic, gastric, esophageal, or gastroesophageal junction cancers with measurable tumors. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you require systemic steroid therapy or other immunosuppressive therapy within 14 days before starting the study treatment, unless it's a low dose or for specific purposes like imaging contrast.

Is there any evidence suggesting that ASP2074 is likely to be safe for humans?

Research has shown that ASP2074 has been promising in early animal studies. These studies found that ASP2074, a drug designed to attack cancer cells while sparing healthy cells, effectively reduced tumors. However, these results come from preclinical studies, conducted before human testing. Researchers are still learning about its safety in people.

Since ASP2074 is in a Phase 1 trial, the main goal is to determine its safety for humans and to find the right dose. Researchers carefully observe how people respond to different doses. At this early stage, limited safety information is available in humans, but every participant is closely monitored for side effects. This monitoring helps researchers understand how the drug works in the human body and what doses are safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ASP2074 because it offers a new approach to treating solid tumors like pancreatic, colorectal, and esophageal adenocarcinomas. Unlike standard treatments that often involve chemotherapy or radiation, ASP2074 works by targeting specific pathways in cancer cells, potentially leading to more effective and focused treatment. This targeted action could result in fewer side effects and improved outcomes for patients. Furthermore, ASP2074 is being tested in a dose escalation and expansion format to optimize its effectiveness and safety, which is promising for those seeking new cancer treatment options.

What evidence suggests that ASP2074 might be an effective treatment for solid tumors?

Research has shown that ASP2074 targets cancer cells with specific proteins, potentially making it effective against solid tumors in the pancreas, colon, and esophagus. In this trial, participants will receive ASP2074 in different treatment arms, each focusing on a specific type of cancer. Early findings suggest that ASP2074 attaches to cancer cells and may inhibit their growth. Data from other studies have shown promising results in similar cancers with targeted treatments. Although human data on ASP2074 remains limited, its targeted action offers hope for people with advanced solid tumors. ^{2 6 7 8 9}

Who Is on the Research Team?

Senior Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have spread and are not responding to standard treatments can join this trial. They must be in good physical condition (ECOG Status of 0 or 1), have recovered from previous therapies, agree to use contraception, and not be pregnant or breastfeeding. Specific cancers like colorectal, pancreatic, gastric cancer, esophageal or GEJ adenocarcinoma are included for certain parts of the study.

Inclusion Criteria

Participant must meet all of the criteria based on laboratory tests. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained >/= 2 weeks after any blood transfusion.

Participant has predicted life expectancy >/= 12 weeks.

I have at least one tumor that can be measured.

Exclusion Criteria

I have not had a stroke or mini-stroke in the last 6 months.

I have had major blood vessel problems, like an aneurysm or clot, in the last 6 months.

I haven't taken strong immune system suppressing drugs in the last 14 days, except for low-dose steroids or a one-time dose for tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part 1)

Participants receive escalating doses of ASP2074 to determine suitable doses for Part 2

Up to 28 days per cycle

Multiple visits per cycle, with extra visits during the first 2 cycles

Dose Expansion (Part 2)

Participants receive ASP2074 at doses determined from Part 1 to find a more accurate dose for future studies

Up to 15 months

Regular visits during treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 21 months

Clinic visits every 6 weeks, then calls every 12 weeks for up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• ASP2074

Trial Overview

ASP2074 is being tested as a new treatment for solid tumors. The trial has two parts: first to find safe doses by giving different amounts to small groups and monitoring for problems; second to confirm these doses in more people. It's given as an infusion at the start of each cycle until it's no longer tolerated or effective.

How Is the Trial Designed?

Group I: ASP2074 Dose Expansion (Part 2) Pancreatic Adenocarcinoma Experimental Treatment 1 Intervention

Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).

Group II: ASP2074 Dose Expansion (Part 2) Esophageal or GEJ Adenocarcinoma Experimental Treatment 1 Intervention

Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).

Group III: ASP2074 Dose Expansion (Part 2) Colorectal Adenocarcinoma Experimental Treatment 1 Intervention

Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).

Group IV: ASP2074 Dose Escalation (Part 1) Experimental Treatment 1 Intervention

Participants will be assigned to sequentially or in parallel escalating dose/regimen cohorts of ASP2074 in three parts (Part A, B and C). Part B and Part C will be opened sequentially based upon sponsor review of emerging data.

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Published Research Related to This Trial

A new combination treatment strategy using the CDK4/6 inhibitor palbociclib shows promise for treating Rb-positive soft tissue sarcomas by inducing cell cycle arrest, making the cancer cells more sensitive to other treatments like doxorubicin.

This synergistic effect was confirmed in both laboratory tests and in vivo studies using patient-derived xenografts, providing strong preclinical support for future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDK4/6 Inhibitors Sensitize Rb-positive Sarcoma Cells to Wee1 Kinase Inhibition through Reversible Cell-Cycle Arrest. Francis, AM., Alexander, A., Liu, Y., et al.[2022]

A genomic analysis of 56 liposarcoma samples revealed that while there were few gene mutations, over half of the samples exhibited gene amplifications, particularly of MDM2, CDK4, and receptor tyrosine kinases (RTKs).

In laboratory tests, combining CDK4 and IGF1R inhibitors effectively suppressed the growth of a well-differentiated liposarcoma cell line with IGF1R amplification, suggesting that this combination therapy could be a promising treatment for patients with these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequent amplification of receptor tyrosine kinase genes in welldifferentiated/ dedifferentiated liposarcoma. Asano, N., Yoshida, A., Mitani, S., et al.[2018]

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