RightFit
RecruitingPhase 1

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP943 Monotherapy in Subjects With Advanced CD123+ Hematologic Malignancies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests VIP943 for people with advanced blood cancers that have a marker called CD123. It aims to find the highest dose people can tolerate or the lowest dose with the best effect on the cancer. It also checks safety and side effects.

Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), or myelodysplastic syndromes (MDS). These are cancers of the blood or bone marrow.
  • Have tried all available standard treatments, or be unable to receive the treatments available.
  • Have at least 5% blasts (immature blood cells) in the blood or bone marrow. For MDS, these must be myeloblasts, a type of immature blood cell.
  • Have a local lab test showing the CD123 marker.
  • Be able to care for yourself and be up and about for at least half of your waking hours, even if you cannot work.

Who can't join

  • Have known cancer spread to the brain, spinal cord, or the tissue covering them.
  • Have serious heart disease, including heart failure that limits activity more than mildly, chest pain at rest, new heart-related chest pain within the past 6 months, or a heart attack within 6 months before the first dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. * Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug activity. * Evidence of CD123 expression from a local laboratory. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: * Known central nervous system (CNS) metastases and/or carcinomatous meningitis. * Clinically significant cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.

Study sites (5)

AL

OH

TN

TX

WA