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ASTX029 for Solid Tumors

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

Subjects with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, who are refractory or have relapsed after treatment with available therapies or for whom standard life-prolonging measures or approved therapies are not available. In Phase 1 Part B and in the Phase 2 portion of the protocol, subjects must also have documented gene alterations in the MAPK pathway as detailed in the protocol

Eastern Cooperative Oncology Group performance status 0 to 2

Must not have

Known infectious diseases or conditions

History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it's safe and effective for people with cancer who can't be treated with other available options.

Who is the study for?

Adults with advanced solid tumors that can't be removed or have spread, and who've tried all other treatments without success. They must be over 18, not pregnant or breastfeeding, willing to use contraception, and able to follow study procedures. Their cancer should have specific gene changes in the MAPK pathway and measurable by certain medical criteria.

What is being tested?

ASTX029 is an oral drug being tested for safety and effectiveness in treating advanced solid tumors. This trial includes multiple phases where researchers will look at how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and any signs of tumor shrinkage.

What are the potential side effects?

While detailed side effects are not provided here, common ones may include fatigue, nausea, diarrhea, liver issues reflected in blood tests, skin rash or itching. Serious side effects could involve heart problems or severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced, cannot be surgically removed, and has not responded to treatment. I also have specific gene changes.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have a known infectious disease or condition.

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I have or am at risk for eye conditions like RVO or CSR.

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I have a significant mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 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

Efficacy (Phase 2) - Response Evaluation Criteria in Solid Tumors using RECIST v1.1

Safety (Phase 1) - Dose-limiting toxicities including incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Efficacy - DCR

Efficacy - DOR

Efficacy - OS

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 Intervention

ASTX029 at the RP2D of the selected dosing regimen identified in Phase 1 to subjects with tumors characterized by gene aberrations in the MAPK signal pathway that may confer sensitivity to ASTX029.

Group II: Phase 1 Regimen 2Experimental Treatment1 Intervention

Dose escalation and expansion: Regimen 2: ASTX029 orally once a day for 14 days of each 21-day cycle.

Group III: Phase 1 Regimen 1Experimental Treatment1 Intervention

Dose escalation and expansion: Regimen 1: ASTX029 orally once a day for 21 days of each 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASTX029

2020

Completed Phase 1

~20