What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often result in a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Targeted therapies, which interfere with specific molecules involved in tumor growth, may lead to side effects such as diarrhea, liver problems, skin rashes, and hypertension. Immunotherapy, which boosts the body's immune response against cancer cells, can cause immune-related adverse effects like colitis, pneumonitis, dermatitis, and endocrinopathies. These side effects vary in severity and frequency depending on the specific agents used and the individual patient's response.

What prior FDA approvals exist?

FDA approvals for the treatment of solid tumors have included various targeted therapies and immunotherapies. While specific approvals for TP53 pathway modulation are limited, drugs like pembrolizumab and nivolumab, which are immune checkpoint inhibitors, have been approved for multiple solid tumors. These drugs work by enhancing the body's immune response against cancer cells. Additionally, targeted therapies such as trastuzumab for HER2-positive breast cancer and osimertinib for EGFR-mutated non-small cell lung cancer have been significant in treating specific genetic profiles of solid tumors. These treatments exemplify the trend towards personalized medicine in oncology.

What other types of research exist?

Promising novel alternatives to ASTX295 for solid tumor patients include: 1) Combination therapies targeting RAS/RAF/MAPK and WNT/β-catenin pathways, such as sorafenib and FH535, which have shown synergistic effects in inhibiting tumor proliferation. 2) ASC-J9® combined with radiotherapy, which enhances radiosensitivity and induces DNA damage, improving therapeutic efficacy in prostate cancer. 3) AZD0156, an ATM inhibitor, which has demonstrated the ability to reverse chemoresistance in neuroblastoma by targeting telomere dysfunction-induced ATM activation.

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Anti-tumor agent

ASTX295 for Solid Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

Phase 2: eligible tumor types as follows: malignant pleural mesothelioma (MPM) (Cohort 1); Liposarcoma (well-differentiated (WD) , de- differentiated (DD), or mix), intimal sarcoma, and other sarcomas with human murine double minute 2 (MDM2) amplification (Cohort 2); Glioblastoma multiforme (GBM) and tumors with CDNK2A loss of function (LOF) excluding MPM, liposarcoma, intimal sarcoma, and uveal melanoma (UVM) (Cohort 3); any solid tumors with molecular feature that may confer sensitivity to ASTX295 (Cohort 4); Uveal melanoma (Cohort 5); Any cancer type with MDM2 amplification excluding MPM, sarcoma, and UVM(Cohort 6).

Have histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable and are refractory or have relapsed after treatment with standard available therapies or for whom standard life-prolonging measures are not available.

Must not have

Abnormal left ventricular ejection fraction.

Known advanced human immunodeficiency virus (HIV) infection (including AIDS): clinical stage ≥ 3 according to WHO classification and/or HIV-associated immunodeficiency.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ASTX295 in patients with advanced solid tumors who have a normal TP53 gene. The study aims to find out if the drug is safe and how it behaves in the body. Researchers want to see if it can help treat cancer without causing harmful side effects.

Who is the study for?

Adults with advanced solid tumors that have not spread and are untreatable or have returned after standard therapy. They must be in fairly good health, able to perform daily activities (ECOG 0-2), and have normal organ function tests. Specific tumor types are eligible for different phases of the trial, all requiring a wild-type TP53 gene.

What is being tested?

ASTX295 is being tested in patients with specific solid tumors containing the wild-type TP53 gene. The study has two parts: Phase 1 to find the right dose and see how safe it is, followed by Phase 2 to check its effectiveness against certain cancers.

What are the potential side effects?

Potential side effects of ASTX295 aren't detailed here but may include typical reactions seen with cancer treatments such as fatigue, nausea, liver issues, or blood count changes based on similar drugs' profiles.

Eligibility Criteria

Inclusion Criteria

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

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My cancer type matches one of the specific categories listed for the trial.

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My cancer has spread, cannot be surgically removed, and does not respond to standard treatments.

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My cancer does not have TP53 mutations.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My kidney function tests are within the normal range.

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I have a tumor sample available for TP53 testing.

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My liver enzymes are within the required limits.

Exclusion Criteria

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

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My heart's pumping ability is below normal.

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I have advanced HIV or AIDS.

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I do not have severe heart failure.

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I do not have unstable heart conditions.

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I haven't taken any experimental drugs recently, and any side effects I had are now mild.

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I have been treated with an MDM2 antagonist before.

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I cannot or will not follow the oral medication rules for ASTX295.

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I have no active cancer other than the one being studied, except for low-risk cancers specified.

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I haven't had major surgery or radiation in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1b: Recommended Phase 2 dose (RP2D) and regimen of ASTX295 to proceed to Phase 2

Phase 2: Disease control rate (DCR) in Cohort 1

Phase 2: Overall response rate (ORR) in Cohorts 2, 3, 4, 5, and 6

Secondary study objectives

Phase 1: Preliminary clinical activity as assessed by objective response rate (ORR) of ASTX295

Phase 1: Preliminary clinical activity of ASTX295 as assessed by disease control rate (DCR)

Phase 2: Overall response rate (ORR) in Cohort 1

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ASTX295Experimental Treatment1 Intervention

0 / 17Eligibility 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

The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as those modulating the TP53 pathway like ASTX295, aim to specifically target molecular abnormalities in cancer cells, thereby minimizing damage to normal cells and improving efficacy. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells. For solid tumor patients, these treatments are crucial as they offer multiple avenues to control or eliminate tumors, potentially improving survival rates and quality of life.

Novel targeted therapies in uterine serous carcinoma, an aggressive variant of endometrial cancer.Gene Expression Profiling Identifies Important Genes Affected by R2 Compound Disrupting FAK and P53 Complex.Practical management of natural killer/T-cell lymphoma.