Acute Myeloid LeukemiaPhase 1NCT06034275
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
A Phase 1 study testing VIP943 (QW) and VIP943 (BIW) in people with Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia, run by Vincerx Pharma, Inc. at 5 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
- What is being tested?
- VIP943 (QW) and VIP943 (BIW)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Sep 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Research Site
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Research Site
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Research Site
- Recruiting
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
Research Site
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Research Site
About this study
Official title: 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
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
Read the detailed description
Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
- Conditions
- Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
- Being tested
- VIP943 (QW), VIP943 (BIW)
- Keywords
- ADC, Hematologic Malignancies, Leukemia, CD123, B-ALL, AML, MDS, Relapsed/ Refractory, Hematologic Diseases, Bone Marrow Diseases
- Medical subject headings
- Leukemia, Myeloid, Acute, Burkitt Lymphoma, Hematologic Neoplasms, Leukemia, Hematologic Diseases, Bone Marrow Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIP943 (QW)Drug
VIP943 will be administered by IV Infusion weekly
VIP943 (BIW)Drug
VIP943 will be administered by IV Infusion bi-weekly
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of VIP943 (QW) | Experimental | Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW). Receives: Drug: VIP943 (QW) |
| Dose Escalation of VIP943 (BIW) | Experimental | Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW). Receives: Drug: VIP943 (BIW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT (Dose limit toxicity) of VIP943
Measured: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Secondary outcomes (3)
Response rate to VIP943 as assessed by investigators using disease-specific response criteria
Measured: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943
Measured: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943
Measured: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start13 Sep 2023
- Primary completion30 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vincerx Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincerx Study Director, Study director, Vincerx Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034275
- Sponsor's protocol ID
- VNC-943-101
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06034275
- Acronym / sponsor ID
- VNC-943-101
- Conditions
- Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
- Keywords
- ADC, Hematologic Malignancies, Leukemia, CD123, B-ALL, AML, MDS, Relapsed/ Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Vincerx Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of VIP943 (QW) | Experimental | Drug: VIP943 (QW)Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW). |
| Dose Escalation of VIP943 (BIW) | Experimental | Drug: VIP943 (BIW)Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIP943 (QW)VIP943 will be administered by IV Infusion weekly | Drug | Dose Escalation of VIP943 (QW) |
| VIP943 (BIW)VIP943 will be administered by IV Infusion bi-weekly | Drug | Dose Escalation of VIP943 (BIW) |
Primary outcome
Incidence of DLT (Dose limit toxicity) of VIP943
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
3 secondary outcomes
Response rate to VIP943 as assessed by investigators using disease-specific response criteria
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincerx Study Director study director
Vincerx Pharma, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIP943 (QW) and VIP943 (BIW) in people with Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia, run by Vincerx Pharma, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincerx Clinical Trials Contact (16508006676, clinicaltrials@vincerx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT (Dose limit toxicity) of VIP943 (time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.