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NCT05476887

To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104

StatusUnknown
PhasePhase 2
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Primary completion date: Mar 2024 to Nov 2024
    • Eligibility criteria expanded, about 128 words
    • Primary endpoints: 3 to 4
    • Study completion date: Sep 2024 to Feb 2025
    • Start date changed from estimate of Feb 2023 to Nov 25, 2022
    • Secondary endpoints: 13 to 9
    • Site details revised at 4 of 4 sites
    • Study arms: 4 to 5
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part 1: Number of participants with Dose-limiting toxicities (DLT)
Timeframe: Up to Week 4
Part 2: Percentage of participants with >= 2 grams per deciliter (g/dL) increase in hemoglobin level from Baseline in the absence of transfusion for weekly dosing
Timeframe: Baseline and at Week 12
Part 2: Percentage of participants with >= 2 g/dL increase in hemoglobin level from Baseline in the absence of transfusion for biweekly dosing
Timeframe: Baseline and at Week 13
Open-label Extension (OLE): Number of participants reporting Treatment Emergent Adverse Events (TEAEs), treatment-emergent serious adverse events (TESAEs) and AEs of special interest (AESIs)
Timeframe: Up to 9 months

Secondary (9)

Part 2: Change from Baseline in serum lactate dehydrogenase (LDH) levels for weekly dosing
Part 2: Change from Baseline in serum LDH levels for biweekly dosing
Part 2: Change from Baseline in hemoglobin level for weekly dosing
Part 2: Change from Baseline in the hemoglobin level for biweekly dosing
Part 2: Change from Baseline in red blood cell (RBC) transfusion dependence for weekly dosing
Show 4 moreShow less
Part 2: Change in RBC transfusion dependence for biweekly dosing
Part 1 and 2: Number of participants reporting TEAEs, TESAEs and AESIs
Part 1 and 2: Concentration within one hour of end of infusion (CEOI) of KP104
Part 1 and 2: Trough concentration (Ctrough) of KP104

Arms and interventions

Part 1: Dose escalation Cohort 1Experimental

Participants will receive escalating and varying dose intervals of KP104 every week.

Part 1: Dose escalation Cohort 2Experimental

Participants will receive escalating and varying dose intervals of KP104 weekly or biweekly.

Part 1: Dose escalation Cohort 3Experimental

Participants will receive escalating and varying dose intervals of KP104 weekly or biweekly.

Part 2: Proof-of-concept Cohort 1Experimental

Participants will receive escalating and varying dose intervals of KP104 weekly or biweekly.

Open-label extension (OLE)Experimental

Participants will receive KP104, who benefit from KP104 treatment in Part 1 and 2

Drugs: KP104

Sites

4 sites in 1 country