ASTX029 for Solid Tumors

Recruiting at 54 trial locations

Overseen By TOI Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Taiho Oncology, Inc.

Must not be taking: ERK inhibitors

Disqualifiers: Cardiac disease, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 1

190 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop certain prior anticancer treatments before starting the study drug. Specifically, you must stop cytotoxic chemotherapy or radiotherapy 3 weeks before, monoclonal antibodies 4 weeks before, and molecularly targeted or investigational drugs 4 weeks before or 5 half-lives, whichever is shorter. Other medications are not specified, so it's best to discuss with the trial team.

What makes ASTX029 unique compared to other drugs for solid tumors?

ASTX029 is unique because it may involve a novel formulation or delivery method that enhances its effectiveness against solid tumors, similar to how other arsenic-based treatments have been modified to improve their therapeutic index and reduce toxicity. ^{1 2 3 4 5}

Research Team

Kim-Hien Dao, DO, PhD

Principal Investigator

Astex Pharmaceuticals, Inc.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Dose escalation and expansion to determine the maximum tolerated dose and recommended Phase 2 dose of ASTX029

21-day cycles

Visits on Day 1 and 2 of each cycle

Phase 2 Treatment

Assessment of preliminary clinical activity in tumors with gene aberrations in the MAPK signal pathway

6 months to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months to 1 year

Treatment Details

Interventions

• ASTX029

Trial Overview 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.

Participant Groups

Group I: Phase 2 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Taiho Oncology, Inc.

Lead Sponsor

Trials

79

Recruited

12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Astex Pharmaceuticals, Inc.

Lead Sponsor

Trials

97

Recruited

7,400+

Dr. Harren Jhoti

Astex Pharmaceuticals, Inc.

Chief Executive Officer since 2007

PhD in Biochemistry from Birkbeck College, London

Dr. Harold N. Keer

Astex Pharmaceuticals, Inc.

Chief Medical Officer since 2020

MD

References

1. China pubmed.ncbi.nlm.nih.gov

[Preliminary report of combination chemotherapy including Arsenic trioxide for stage III osteosarcoma and Ewing sarcoma]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A novel nanoparticulate formulation of arsenic trioxide with enhanced therapeutic efficacy in a murine model of breast cancer. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

New tumor-targeted nanosized delivery carrier for oligonucleotides: characteristics in vitro and in vivo. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of KML001 monotherapy in patients with advanced solid tumors. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Arsenene Nanodots with Selective Killing Effects and their Low-Dose Combination with ß-Elemene for Cancer Therapy. [2022]