ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma

(ATX-101 Trial)

Overseen by Benjamin Izar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Benjamin Izar

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new IV drug called ATX-101 for patients with specific types of cancer (LPS and LMS) who haven't had success with other treatments. ATX-101 blocks a protein interaction that helps cancer cells survive, potentially making it an effective treatment option.

Research Team

Benjamin Izar, MD

Principal Investigator

Columbia University

Eligibility Criteria

Inclusion Criteria

Disease must be locally advanced and unresectable or metastatic. Disease which may be resected but with an associated level of morbidity deemed unacceptable by the treating clinician is considered eligible

Patients must evidence of disease progression, either clinically or radiographically, within the 12 weeks prior to study enrollment, as determined by the investigator enrolling the patient on the study

Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria

Patients may not have received treatment with a small molecule targeted agent (including off-label or investigational use) within 14 days of initiating treatment on this protocol, provided this represents at least 7 half-lives for that agent

Toxic effects from any prior therapy (except alopecia) must have resolved to grade 1 or less according to NCI CTCAE v4.0 or to the patient's baseline by the time of initiating treatment on this protocol

Anticipated requirement for surgery during the study period or major surgery within 3 weeks of initiating treatment

Treatment Details

Interventions

• ATX-101 (PCNA inhibitor)

Participant Groups

Group I: ATX-101 Experimental Treatment 1 Intervention

Patients will be treated with ATX-101 60 mg/m2 IV weekly in continuous 21 day cycles. Patients will receive premedication prior to the ATX-101 infusion to reduce the risk of infusion-related reactions.

Who Is Running the Clinical Trial?

Benjamin Izar

Lead Sponsor

Trials

1

Recruited

4+

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+