Onalespib + CDKI AT7519 for Advanced Cancer

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Steroids, Anti-epileptics, Antiretrovirals

Disqualifiers: Brain metastases, Cardiac arrhythmia, others

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

Compensation: Varies

Number of Visits: 4

Duration: 21 days per cycle

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of onalespib and CDKI AT7519 in treating patients with solid tumors that have spread from the primary site (place where they started) to other places in the body (metastatic) or cannot be removed by surgery. Onalespib and CDKI AT7519 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Khanh T Do

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

This trial is for adults with solid tumors that have spread or can't be surgically removed, and who've recovered from previous treatments (except hair loss). They should not be pregnant, must use birth control, and have a life expectancy over 3 months. Participants need normal organ function tests and measurable disease by certain medical imaging standards.

Inclusion Criteria

My cancer can be measured or evaluated using specific criteria.

My kidney function is within the normal range.

Contraception and pregnancy requirements: Women of childbearing potential and male patients with partners of childbearing potential must agree to use adequate contraception, breastfeeding should be discontinued while the mother is treated with onalespib and AT7519M

Exclusion Criteria

I have brain metastases or carcinomatous meningitis but meet certain conditions.

Patients who are receiving any other investigational agents

I have not had chemotherapy or radiotherapy recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive onalespib IV over 1 hour on days 1 and 4 (cycle 0 only), then onalespib IV and CDKI AT7519 IV over 1 hour on days 1, 4, 8, and 11 (cycle 1 and subsequent cycles). Cycles repeat every 21 days.

21 days per cycle

4 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• CDKI AT7519
• Onalespib

Trial Overview The study is testing the safety and optimal dosages of two drugs, Onalespib and CDKI AT7519, in patients with advanced solid tumors. These drugs are believed to inhibit enzymes necessary for tumor cell growth. The trial will also analyze biomarkers in the lab to understand how these drugs work.

Participant Groups

Group I: Treatment (onalespib, CDKI AT7519) Experimental Treatment 4 Interventions

Patients receive onalespib IV over 1 hour on days 1 and 4 (cycle 0 only). Patients then receive onalespib IV over 1 hour and CDKI AT7519 IV over 1 hour on days 1, 4, 8, and 11 (cycle 1 and subsequent cycles thereafter). Cycles repeat every 21 days (7 days for course 0 only) in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+