A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV) (NCT06985147) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
United States60 participantsStarted 2025-08-12
Plain-language summary
This open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged 18 years or older at the time of signing the informed consent form (ICF).
✓. Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV.
✓. Complete blood count values at Screening of HCT \<45% or HCT \<48% if followed by a phlebotomy within 2 weeks, white blood cells 4000/μL to 20,000/μL (inclusive), and platelets 100,000/μL to 1,000,000/μL (inclusive).
✓. At least 3 phlebotomies in 26 weeks before Screening or at least 5 phlebotomies in 52 weeks before Screening. At least 1 phlebotomy must be within the 12 weeks prior to Screening.
✓. Participants receiving cytoreductive therapy must have been taking for at least 6 months and be on a stable PV therapy regimen for at least 2 months for hydroxyurea, interferon or ruxolitinib with no anticipated need for dose adjustments during the study, or have decreasing dose (with medical monitor approval).
✓. Participants treated with phlebotomy alone must have stopped cytoreductive therapy 6 months before Screening.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or with medical monitor approval, ECOG 2.
✓. If male with female sexual partner(s) of childbearing potential, agrees to use one of the following acceptable methods of contraception during the study and for at least 120 days after the last study drug dose:
Exclusion criteria
✕. Clinically significant laboratory abnormalities at Screening.
✕
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE
Timeframe: Up to 365 days
2
Incidence of clinically abnormal vital signs
Timeframe: Up to 365 days
3
Incidence of clinically abnormal physical exam
Timeframe: Up to 365 days
4
Incidence of clinically abnormal electrocardiograms
. Participants who require phlebotomy at HCT levels \<45%.
✕. Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to study treatment.
✕. Clinically significant active or chronic bleeding, considered meaningful in consultation with the medical monitor, within 6 months prior to study treatment.
✕. Significant renal dysfunction, evidenced by estimated glomerular filtration rate of \<30 mL/min/1.73 m2 at the Screening visit, as assessed locally.
✕. History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer, or other malignancies deemed acceptable by the Sponsor.
✕. Participants with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during Screening unless the cancer is adequately treated before study entry.
✕. Received busulfan, pipobroman, or phosphorus-32 within 7 months prior to Screening.