Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer
TerminatedPhase 1, PHASE2Results postedLast updated 12 January 2021
What this trial tests
Phase 1, PHASE2 trial testing BAX69 Single-Route Arm in Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites in 2 participants. Terminated before completion.
18 and older, female only, with Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Occurrence of Dose-limiting Toxicity (DLT)Primary· 4 weeks
DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria: - Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure in 7 days; Transient grade 3 elevations of hepatic transaminases in the absence of simultaneous incre
Group
Value
95% CI
Single-Route Arm
0
Double-Route Arm
0
Occurrence of Serious Adverse Events (SAEs) and/or Treatment-emergent Adverse Events (TEAEs), Regardless of Causality or Relationship to Study DrugSecondary· Throughout the study period of approximately 22 months
SAEs
Group
Value
95% CI
Single-Route Arm
0
Double-Route Arm
0
TEAEs related to study drug
Group
Value
95% CI
Single-Route Arm
0
Double-Route Arm
0
TEAEs not related to study drug
Group
Value
95% CI
Single-Route Arm
1
Double-Route Arm
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of Imalumab (BAX69) until study completion/discontinuation or 56 (±2 days) following the last dose of Imalumab..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability of the RP2D and explore clinical signs of efficacy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baxalta now part of Shire
Last refreshed: 12 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02540356.