DCC-3014 for Giant Cell Tumor

Recruiting at 23 trial locations

Overseen By Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Deciphera Pharmaceuticals, LLC

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

Compensation: Varies

Number of Visits: 26

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multicenter, open-label Phase 1/2 study of vimseltinib in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticancer or TGCT therapy, including investigational therapy, at least 2 weeks before starting the study drug. If the therapy has a longer half-life, you may need to stop 28 days prior. Also, you cannot take proton-pump inhibitors during the trial.

Research Team

Maitreyi Sharma, MD

Principal Investigator

Deciphera Pharmaceuticals, LLC

Eligibility Criteria

Adults with advanced tumors or tenosynovial giant cell tumor (TGCT) that can't be surgically removed may join this trial. They must have measurable lesions, good organ and bone marrow function, and agree to contraception if applicable. Those with certain heart conditions, recent major surgery, active infections like HIV or hepatitis, or who are pregnant/lactating cannot participate.

Inclusion Criteria

I am not pregnant and agree to use birth control during the study.

I have an advanced tumor or TGCT that cannot be removed by surgery.

I have a solid tumor and can perform all my daily activities without help.

Exclusion Criteria

I have received cancer treatment, including trials, within the specified time before starting the study drug.

I do not have HIV, hepatitis B, hepatitis C, or tuberculosis.

I have a condition that affects how my body absorbs medication taken by mouth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of vimseltinib beginning at 10 mg once daily for 28-day cycles until disease progression or unacceptable toxicity

28 days per cycle

Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1

Expansion

Dosing of different patient cohorts at the dose level determined from the Dose Escalation Phase

Estimated up to 24 months

At Week 25 (Cycle 7, Day 1)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DCC-3014

Trial Overview The study is testing DCC-3014 in two phases: Phase 1 (Dose Escalation) includes patients with malignant solid tumors and TGCT; Phase 2 (Expansion) has two cohorts of only TGCT patients. The goal is to find the right dose and see how well it works against these tumors.

Participant Groups

Group I: Experimental Treatment Experimental Treatment 1 Intervention

Dose Escalation Phase: Increasing doses of vimseltinib beginning at 10 milligram (mg) once daily (QD) for 28 day cycles until disease progression or unacceptable toxicity. Expansion Phase: Dosing of different patient cohorts at the dose level determined from the Dose Escalation Phase of the study.

Who Is Running the Clinical Trial?

Deciphera Pharmaceuticals, LLC

Lead Sponsor

Trials

19

Recruited

2,100+

Deciphera Pharmaceuticals LLC

Lead Sponsor

Trials

17

Recruited

1,900+