A study to test how different doses of BI 1703880 in combination with ezabenlimab are tolerated in people with different types of advanced cancer (solid tumours)

JRCT ID: jRCT2031220591

Registered date:27/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: advanced, unresectable and/or metastatic solid tumours
• Date of first enrollment: 19/01/2023
• Target sample size: 66
• Countries of recruitment: Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Intravenous infusion of BI 1703880 and ezabenlimab

Outcome(s)

• Primary Outcome: Occurrence of DLTs during the MTD evaluation period

Secondary Outcome

Occurrence of DLTs during the on-treatment period
PK parameters Cmax and AUC0-tz

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Adult male or female patients with histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic malignant solid tumour
Patient must have exhausted or refused established treatment options known to prolong survival for the malignant disease, or is not eligible for established treatment options
Patient must have at least 1 lesion amenable to pre-treatment and on-treatment biopsy
ECOG 0 or 1 and life expectancy of at least >= 3 months after the start of the treatment according to the Investigator's judgement
Adequate organ function or bone marrow reserve as demonstrated at screening by laboratory values

Exclude criteria

Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter
Radiation therapy within 4 weeks prior to the first treatment
Prior STING agonist therapy
Prior intolerability of a PD-1 or anti-PD-L1 therapy
Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding >10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers
Persistent toxicity from previous treatments (including irAEs) that has not resolved to Grade <=1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies
History or evidence of active, non-treatment related autoimmune disease, except for endocrinopathies
History of pneumonitis related to prior immunotherapy
Positive and confirmed SARS-COV-2 test on Cycle 1 Day 1.
Presence of other active invasive cancers other than the one treated in this trial within 3 years prior to screening
Presence or history of uncontrolled or symptomatic brain or
subdural metastases unless local therapy has ended, and metastases considered stable for at least the prior three months

Related Information

• Primary Sponsor: Tsunoda Toru