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KANDOVA - A two-part Phase Ib/IIa study to evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567. An open-label, multicenter dose escalation study with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515572-13-00
Acronym
KAN0007
Enrollment
30
Registered
2024-10-01
Start date
2023-04-26
Completion date
2025-04-03
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Brief summary

Occurrence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)., The safety endpoint parameters are frequency and severity of AEs, vital signs, electrocardiography (ECG), and the results of laboratory safety tests and urinalysis., RPIID of KAND567 in combination with carboplatin therapy will be determined based on safety and tolerability (Part 1/Phase Ib only).

Detailed description

ORR at Weeks 12 and 18, according to RECIST 1.1 and GCIG definitions, i.e., best overall response in subjects with measurable disease, or without measurable disease evaluable by CA 125., Progression-free survival (PFS) at Weeks 12 and 18., Overall survival (OS) at end of study., Disease control rate (DCR) (Complete response [CR] + Partial response [PR] + Stable disease [SD]) at Weeks 12 and 18., Duration of response according to RECIST 1.1 and GCIG definitions (time from documentation of tumor response to disease progression)., KAND567 PK drug concentration data will be graphically visualized together with normalized PK drug concentration data from the previous KAN0001 study (i.e., no formal PK analysis will be performed)., Change in pain score, as measured by the Numeric Rating Scale (NRS) from baseline (Week 1) to Weeks 4, 7, 10, 13, 16 and 20.

Interventions

DRUGlösning
DRUGCarboplatin Actavis 10 mg/ml koncentrat till infusionsvätska
DRUGCarboplatin Accord 10 mg/ml konsentrat til infusjonsvæske
DRUGoppløsning
DRUGCarboplatin Ebewe 10 mg/ml koncentrat till infusionsvätska
DRUGCarboplatin ”Accord”
DRUGopløsning
DRUGCarboplatin Fresenius Kabi
DRUGCarboplatin Fresenius Kabi 10 mg/ml konsentrat til infusjonsvæske
DRUGCarboplatin ”Actavis”
DRUGCarboplatin "Ebewe"

Sponsors

Kancera AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)., The safety endpoint parameters are frequency and severity of AEs, vital signs, electrocardiography (ECG), and the results of laboratory safety tests and urinalysis., RPIID of KAND567 in combination with carboplatin therapy will be determined based on safety and tolerability (Part 1/Phase Ib only).

Secondary

MeasureTime frame
ORR at Weeks 12 and 18, according to RECIST 1.1 and GCIG definitions, i.e., best overall response in subjects with measurable disease, or without measurable disease evaluable by CA 125., Progression-free survival (PFS) at Weeks 12 and 18., Overall survival (OS) at end of study., Disease control rate (DCR) (Complete response [CR] + Partial response [PR] + Stable disease [SD]) at Weeks 12 and 18., Duration of response according to RECIST 1.1 and GCIG definitions (time from documentation of tumor response to disease progression)., KAND567 PK drug concentration data will be graphically visualized together with normalized PK drug concentration data from the previous KAN0001 study (i.e., no formal PK analysis will be performed)., Change in pain score, as measured by the Numeric Rating Scale (NRS) from baseline (Week 1) to Weeks 4, 7, 10, 13, 16 and 20.

Countries

Denmark, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026