ATI-2231 for Solid Tumor Cancers

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byCynthia X Ma, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ATI-2231 in patients with serious types of cancer to determine the most effective dose.

Research Team

Cynthia X Ma, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

For the capecitabine cohort, you must have completed a 3-week washout period from any prior chemotherapy other than capecitabine and completely recovered all adverse events (AEs) to Grade 1 (except alopecia).

You have abstained from previous chemotherapy for three weeks or a sufficient amount of time has elapsed since your last dose that any adverse effects have been reduced to Grade 1 (excluding hair loss).

Your absolute neutrophil count is at least 1,500/mcL.

See 21 more

Exclusion Criteria

You have had an allergic reaction to drugs similar to ATI-2231 or other drugs being used in the study.

Untreated brain metastases. Patients with treated brain metastases are eligible if they show no evidence of progression and are off steroids or on stable/decreasing steroid dose.

History of acute, untreated skeletal related events (SRE) or active untreated SRE or a change or an anticipated change in the SOC antiresorptive agents after entering the study (Phase II only).

See 5 more

Treatment Details

Interventions

ATI-2231 (Other)
Bisphosphonate (Other)
Capecitabine (Other)
Denosumab (Other)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ATI-2231 monotherapy dose escalationExperimental Treatment1 Intervention

* Patients will receive single agent ATI-2231 at assigned dose levels (n=3-6 per dose level). Starting dose of 20 mg by mouth twice per day. * Each cycle is 21 days