BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

July 28, 2022

Primary Completion Date

February 7, 2024

Study Completion Date

February 7, 2024

Conditions
HER2-positive Breast CancerHER2-positive Gastric CancerHER2-positive Metastatic Breast CancerMetastatic Gastroesophageal Junction AdenocarcinomaMetastatic Gastric Adenocarcinoma
Interventions
DRUG

BI-1607

administered at different doses in Phase I by intravenous infusions every 3 weeks.

DRUG

BI-1607

administered at the recommended dose in Phase 2a by intravenous infusions every 3 weeks.

DRUG

Trastuzumab

administered at 8mg/kg for the first infusion and at 6mg/kg in subsequent infusions by intravenous infusions every 3 weeks.

Trial Locations (6)

28034

Complejo hospitalario Ruber Juan Bravo, Madrid

45136

Evang. Kliniken Essen-Mitte, Essen

60488

Krankenhaus Nordwest, Frankfurt

08035

Hospital Vall d'Hebron, Barcelona

OX3 7LE

Churchill Hospital, Oxford

SO16 6YD

Southampton General Hospital, Southampton

Sponsors
All Listed Sponsors
lead

BioInvent International AB

INDUSTRY

NCT05555251 - BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors | Biotech Hunter | Biotech Hunter