ASTX029 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+54 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Taiho Oncology, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to subjects with advanced solid malignancies who are not candidates for approved or available therapies.

Eligibility Criteria

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.

Inclusion Criteria

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

Women of child-bearing potential must meet specific requirements for pregnancy prevention

My cancer can be biopsied.

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Exclusion Criteria

I have a history of heart problems or am at risk for them.

I do not have any severe illnesses or conditions that could risk my safety or affect the study's results.

I have not had cancer treatments within the restricted time frame.

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Treatment Details

Interventions

ASTX029 (Other)

Trial OverviewASTX029 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.

Participant Groups

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.