Oral GB2064 for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byRichard F Schlenk, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Galecto Biotech AB

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called GB2064, which blocks a protein known as LOXL-2. It is aimed at patients with Myelofibrosis, a condition where the bone marrow becomes scarred. By blocking LOXL-2, the medication hopes to reduce this scarring and improve symptoms.

Research Team

Richard F Schlenk, MD

Principal Investigator

Universitätsklinikum Heidelberg, Germany

Eligibility Criteria

Adults over 18 with Myelofibrosis who haven't responded well to, or can't take, JAK inhibitors. They should have a low blast count in blood, be able to perform daily activities (ECOG 0-2), and have proper organ function. Women must use effective birth control or be non-childbearing; men must also agree to contraception.

Inclusion Criteria

Peripheral blood blasts <10%

You are not currently taking a medication called Janus kinase (JAK) inhibitor and cannot take it due to medical reasons.

Female participants may be of non-childbearing potential defined as permanently sterile or postmenopausal, or female participants considered to be of childbearing potential who agree to use highly effective birth control methods until 90 days after the follow-up visit.

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Exclusion Criteria

Hypersensitivity to GB2064 and/or its excipients.

Current treatment with a JAK inhibitor (e.g. ruxolitinib or fedratinib) or a history of treatment with a JAK inhibitor within two weeks of enrolment.

Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy.

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Treatment Details

Interventions

GB2064 (Unknown)

Trial OverviewThe trial is testing GB2064, an oral medication for Myelofibrosis patients. It's an open-label phase IIa study which means everyone gets the drug and both the researchers and participants know what's being given.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GB2064Experimental Treatment1 Intervention

GB2064 will be administered orally as 4 x 250 mg tablets twice a day.