VIP943 for Blood Cancers

Recruiting at 4 trial locations

Overseen By Vincerx Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vincerx Pharma, Inc.

Disqualifiers: CNS metastases, Cardiac disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, VIP943, for treating certain blood cancers. Researchers aim to find the safest and most effective dose while ensuring its safety. The trial targets blood cancers like AML, MDS, and B-ALL, particularly when cancer cells display the CD123 marker. It suits individuals who have tried other treatments without success and cannot pursue other standard treatments. Participants will receive the drug either once or twice a week to determine the optimal schedule. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that VIP943 is likely to be safe for humans?

Research has shown that VIP943 is safe in early studies. In these studies, some patients with advanced CD123-positive blood cancers experienced significant tumor reduction or complete remission, suggesting the treatment's effectiveness at certain doses.

The studies also found that VIP943 was well-tolerated, with patients not experiencing severe side effects. These findings come from early research focused on determining the optimal dose and assessing safety.

Since the trial is in its first phase, the main goal is to ensure the treatment's safety and identify the correct dose. Although information is limited, early results are promising for safety. Ongoing monitoring is crucial as more data becomes available. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for blood cancers?

Researchers are excited about VIP943 for blood cancers because it represents a novel approach to targeting cancer cells. Most treatments for acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) focus on broad chemotherapy or immunotherapy strategies. In contrast, VIP943 specifically targets CD123, a protein commonly found on the surface of cancerous cells in these conditions, allowing for more precise treatment. This targeted approach may reduce damage to healthy cells and potentially improve outcomes. Additionally, the treatment is administered intravenously, with options for both weekly and twice-weekly dosing, offering flexibility in managing patient care.

What evidence suggests that VIP943 might be an effective treatment for blood cancers?

Research has shown that VIP943 holds promise for treating certain blood cancers. In an early study, two patients with advanced blood cancers marked by CD123 experienced complete disappearance of their cancer symptoms after receiving VIP943. Lab tests on animals demonstrated that VIP943 slowed tumor growth significantly more than other treatments. Ongoing research indicates that VIP943 is effective for patients with relapsed or hard-to-treat acute myeloid leukemia (AML). In this trial, participants will receive VIP943 on one of two dosing schedules: weekly (QW) or twice weekly (BIW). These findings suggest that VIP943 could be a valuable treatment option for blood cancers, particularly those with CD123 markers. ^{2 3 6 7 8}

Who Is on the Research Team?

Vincerx Study Director

Principal Investigator

Vincerx Pharma, Inc.

Are You a Good Fit for This Trial?

This trial is for people with advanced blood cancers like leukemia, who have a specific marker called CD123. They should be fairly active and able to care for themselves (ECOG 0-2) and must have tried all standard treatments or can't receive them. People with brain cancer spread or serious heart problems cannot join.

Inclusion Criteria

My cancer cells show CD123 presence.

I can take care of myself and am up and about more than half of my waking hours.

My leukemia or myelodysplastic syndrome has not responded to standard treatments.

Exclusion Criteria

I do not have serious heart problems like recent heart attacks or severe chest pain.

My cancer has spread to my brain or its coverings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VIP943 in sequential ascending doses as a monotherapy via intravenous administration

8-12 weeks

Weekly or twice weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VIP943

Trial Overview The study is testing VIP943's safety and finding the highest dose patients can take without severe side effects in those with CD123+ hematologic malignancies. It starts with small doses that increase until they find the right balance between effectiveness and safety.

How Is the Trial Designed?

Group I: Dose Escalation of VIP943 (QW) Experimental Treatment 1 Intervention

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).

Group II: Dose Escalation of VIP943 (BIW) Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Vincerx Pharma, Inc.

Lead Sponsor

Trials

4

Recruited

180+

Published Research Related to This Trial

In a Phase II study involving 14 patients with advanced cervical carcinoma, the combination of VP-16 (etoposide), ifosfamide, and cisplatin (VIP) resulted in complete responses in 8 patients, with response durations lasting between 7 to over 24 months.

The VIP chemotherapy regimen was well-tolerated overall, with manageable hematologic toxicity being the primary side effect, indicating its potential as an effective treatment option for advanced cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etoposide (VP-16), ifosfamide/mesna, and cisplatin chemotherapy for advanced and recurrent carcinoma of the cervix. Kredentser, DC.[2019]

In a study of 24 patients with advanced or relapsed soft tissue sarcoma treated with the VIP regimen (etoposide, ifosfamide, and cisplatin), the overall response rate was 37.5%, indicating that VIP may be an effective second-line treatment option.

Patients who responded to previous chemotherapy showed significantly better overall survival (11.0 months) compared to nonresponders (8.8 months), highlighting the importance of prior treatment response in predicting outcomes with VIP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VIP (etoposide, ifosfamide, and cisplatin) in patients with previously treated soft tissue sarcoma. Moon, JY., Baek, SW., Ryu, H., et al.[2021]

In a study of 16 patients with metastatic germ cell tumors, 81% achieved a complete response to VIP therapy, which includes etoposide, ifosfamide, and cisplatin, indicating its effectiveness as a first-line chemotherapy.

The treatment was well tolerated despite causing significant myelosuppression (Grade 3 or higher), with no treatment-related deaths, suggesting that VIP therapy is a safe option for patients with good and intermediate prognostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment results of VIP (etoposide, ifosfamide and cisplatin) chemotherapy as a first-line therapy in metastatic germ cell tumors]. Yoshida, T., Yonese, J., Kitsukawa, S., et al.[2019]

In a study involving 38 adult patients with relapsed or refractory acute myeloid leukemia, VP-16-213 demonstrated an overall response rate of 18%, with 5% achieving complete remission and 13% partial remission.

The treatment was associated with mild toxicity and rare instances of aplasia, showing that it is a relatively safe option for patients across all myeloid subtypes, including those who had never achieved remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of VP 16-213 in adults with refractory acute myeloid leukemia. An Eastern Cooperative Oncology Group study. Bennett, JM., Lymann, GH., Cassileth, PA., et al.[2019]

In a study involving 10 acute leukemia patients, the new cytostatic agent VP 16-213 demonstrated effectiveness, achieving one complete remission and two partial remissions, indicating its potential as a treatment option for various forms of acute leukemia.

VP 16-213 has a relatively mild toxic effect and a unique mechanism of action, suggesting it could be safely integrated into combination chemotherapy regimens and warrants further clinical trials, especially for patients with refractory acute leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Initial results with a epipodophyllotoxin derivative VP 16-213 in the treatment of acute leukemia]. Cavalli, F., Ryssel, HJ., Batz, K., et al.[2013]

AVE9633, an immunoconjugate targeting CD33 in acute myeloid leukemia (AML), shows that P-glycoprotein (P-gp) activity can reduce its cytotoxic effects, but this is not the main cause of resistance in AML patients, as 40% of samples were resistant regardless of P-gp levels.

The study suggests that combining AVE9633 with other treatments may be beneficial for AML patients resistant to standard therapies, as resistance mechanisms may involve factors beyond P-gp, such as alterations in microtubules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

P-gp activity is a critical resistance factor against AVE9633 and DM4 cytotoxicity in leukaemia cell lines, but not a major mechanism of chemoresistance in cells from acute myeloid leukaemia patients. Tang, R., Cohen, S., Perrot, JY., et al.[2021]

In a study of 10 patients with reactivated stage D prostatic cancer, the combination therapy of vincristine, ifosfamide, and peplomycin (VIP therapy) provided significant relief from bone pain in 50% of patients and improved urinary symptoms in 33%.

Despite some symptomatic relief, the overall objective response rate for treating primary and metastatic lesions was low, ranging from 10% to 20% depending on the evaluation criteria, with mild to moderate toxicity reported, except for one case of hepatic insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combination chemotherapy of vincristine, ifosfamide and peplomycin in patients with reactivated prostatic cancer]. Kazama, T., Katayama, T., Umeda, K., et al.[2015]

Citations

1. onclive.com onclive.com/view/vip943-generates-early-complete-responses-is-safe-in-advanced-cd123-hematologic-malignancies

VIP943 Generates Early Complete Responses, Is Safe in ... Complete responses were achieved by 2 patients with advanced CD123-positive hematologic malignancies who received VIP943 in a phase 1 study.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06034275

NCT06034275 | Study of VIP943 in Subjects With ... 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) ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS3167

An open-label, multicenter phase 1 study to characterize ... In an in vivo MOLM-13 model, VIP943 had statistically significant (p <0.001) improvement in tumor growth inhibition compared with the only ADC ...

4. synapse.patsnap.com synapse.patsnap.com/article/vincerx-shares-positive-early-results-from-vip943-phase-1-study-and-provides-updates

Vincerx Shares Positive Early Results from VIP943 Phase 1 ... In an ongoing Phase 1 dose-escalation study, VIP943 has demonstrated significant efficacy in patients with relapsed/refractory acute myeloid leukemia (AML), ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT06034275

Study of VIP943 in Subjects With Advanced CD123+ ... "VIP943 has shown promising safety, efficacy, and tolerability in an ongoing Phase 1 dose-escalation study for patients with relapsed/refractory acute myeloid ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06034275

Study of VIP943 in Subjects With Advanced CD123+ ... 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) ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/424415

Study of VIP943 in Subjects With Advanced CD123+ ... 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.

8. ctv.veeva.com ctv.veeva.com/study/phase-1-dose-escalation-study-for-vip943-subjects-with-advanced-cd123-hematologic-malignancies

Study of VIP943 in Subjects With Advanced CD123+ ... Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug ...