What side effects are associated with this type of intervention?

Common treatments for solid tumors, including investigational drugs like ASP2074, often have side effects such as fatigue, nausea, vomiting, and hematologic toxicities like neutropenia and anemia. Other potential side effects include diarrhea, rash, and pruritus. Close monitoring during clinical trials is essential to identify and manage any unique or severe adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, particularly focusing on targeted therapies and immunotherapies. Examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), which are immune checkpoint inhibitors targeting PD-1/PD-L1 pathways, and have shown efficacy in various solid tumors such as melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, targeted therapies like erlotinib (Tarceva) for EGFR-mutated non-small cell lung cancer and vemurafenib (Zelboraf) for BRAF-mutated melanoma have been significant. These treatments, similar to ASP2074, aim to provide more personalized and effective options for patients with advanced solid tumors.

What other types of research exist?

Promising novel alternatives to ASP2074 for solid tumor patients include: <ol> <li>Pembrolizumab (Keytruda) - an anti-PD-1 therapy showing efficacy in various solid tumors.</li> <li></li> </ol> Nivolumab (Opdivo) combined with Ipilimumab (Yervoy) - a combination immunotherapy for advanced solid tumors. 3. Lenvatinib combined with Pembrolizumab - a combination showing promise in advanced hepatocellular carcinoma and other solid tumors. 4. Durvalumab (Imfinzi) combined with chemotherapy - showing efficacy in advanced biliary tract cancer. 5. Cabozantinib (Cabometyx) - a tyrosine kinase inhibitor for advanced renal cell carcinoma and other solid tumors.

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Other

ASP2074 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has progressed or failed to tolerate after receiving all standard approved therapies or is no longer eligible for standard therapy (no limit to the number of prior treatment regimens).

Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1.

Must not have

Participant has received other investigational agents or devices concurrently or within 21 days or 5 half-lives, whichever is shorter, prior to first dose of study intervention administration.

Participants with squamous cell colorectal carcinoma; gastrointestinal stromal cancer and neuroendocrine carcinomas.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called ASP2074 for adults with advanced cancers that have spread and no longer respond to standard treatments. The drug is given through an infusion, and the study will find the best dose and check for side effects. Patients will be closely monitored throughout the treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't detailed but will include any medical problems arising from ASP2074 during treatment cycles. These could range from mild reactions at the infusion site to more serious issues affecting organs due to drug toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition worsened or I couldn't handle the side effects after all standard treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My side effects from previous treatments, except for hair loss, have mostly gone away or returned to normal.

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I have an advanced solid tumor or specific types of cancer with no limit on prior treatments.

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My condition worsened or I couldn't handle the side effects after all standard treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I will not donate eggs during and for 3 months after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any experimental drugs or used experimental devices within the last 21 days or 5 half-lives, whichever is shorter.

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My cancer is either squamous cell colorectal, gastrointestinal stromal, or neuroendocrine.

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I weigh less than 40 kg.

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I stopped previous immune therapy due to severe side effects.

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I am hepatitis B core antibody positive but will be excluded if my hepatitis B virus DNA test is positive.

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I have or had lung inflammation not caused by an infection.

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I have had a bone marrow or organ transplant from another person.

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I do not have a history of significant heart disease.

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My high blood pressure is not well-controlled despite taking medication.

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I have moderate to severe heart failure.

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I have a heart rhythm problem or use a pacemaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Dose Limiting Toxicities (DLTs) for ASP2074

Number of participants with Adverse Events (AEs)

Number of participants with Serious Adverse Events (SAEs)

+3 more

Secondary study objectives

Change from Baseline in Serum CA19-9 levels in participants with pancreatic cancer

Change from Baseline in target antigen expression

Change from Baseline in tumor CD8 infiltration/ activation

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: ASP2074 Dose Expansion (Part 2) Pancreatic AdenocarcinomaExperimental Treatment1 Intervention

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

Group II: ASP2074 Dose Expansion (Part 2) Esophageal or GEJ AdenocarcinomaExperimental Treatment1 Intervention

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

Group III: ASP2074 Dose Expansion (Part 2) Colorectal AdenocarcinomaExperimental Treatment1 Intervention

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

Group IV: ASP2074 Dose Escalation (Part 1)Experimental Treatment1 Intervention

Participants will be assigned to sequentially 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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include targeted therapies, immunotherapies, and cytotoxic chemotherapies. Targeted therapies, like ASP2074, aim to interfere with specific molecules involved in tumor growth and progression, such as growth factor receptors or signaling pathways. Immunotherapies boost the body's immune system to recognize and destroy cancer cells. Cytotoxic chemotherapies kill rapidly dividing cells, including cancer cells, by damaging their DNA or interfering with cell division. These treatments are crucial for solid tumor patients as they offer different mechanisms to control or eliminate cancer, potentially improving outcomes and providing options when standard therapies fail.

The challenge of targeted therapies for gastric cancer patients: the beginning of a long journey.Potential molecular targets for Ewing's sarcoma therapy.[The handling of anti-cancer drugs in elderly patients].