A study to test whether different combinations of BI 765063, ezabenlimab, chemotherapy, cetuximab, and BI 836880 help people with head and neck cancer or liver cancer

Phase 1

Recruiting

Conditions: Patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular c

Registration Number: JPRN-jRCT2031210650

Lead Sponsor: Tsunoda Toru

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Patients homozygous for V1 allele (including V1-like alleles) of SIRPa
Patients with at least one measurable lesion as per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status <=1
For patients with HNSCC only (Cohorts A and B)
Patients with recurrent or metastatic histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx which is considered incurable by local therapies (e.g. surgery, radiotherapy).
Immune checkpoint inhibitor naive patients who progressed on a standard platinum-based therapy in the recurrent/metastatic setting.
For patients with HCC only (Cohorts C, D, and E)
Patients with locally advanced/metastatic and/or unresectable HCC as confirmed histologically or by diagnostic imaging (dynamic Computed Tomography CT or Magnetic Resonance Imaging MRI) according to AASLD criteria
60 patients who have not received prior systemic therapy will be randomized in 2 1st line HCC.
30 patients who have progressed on 1st line atezolizumab+bevacizumab therapy/regimen will be included in a 2nd line HCC.
Child-Pugh Score of A.

Exclusion Criteria

Patients with at least one SIRPa V2 allele, i.e. SIRPa V1/V2 or V2/V2 individuals.
Previous treatment with any anti-PD-(L)1, anti-SIRPa, or anti-VEGF (for cohorts using BI 836880 only), except for patients treated in 2nd line HCC cohort where previous treatment with atezolizumab+bevacizumab is required.
For patients with HNSCC only (Cohorts A and B )
Patients with nasopharyngeal carcinoma.
For patients with HCC only (Cohorts C, D and E)
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
Tumour of diffuse infiltrative HCC type (hypovascular infiltrative tumours with ill-defined borders).
Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
History of recent bleeding disorders or risk of bleeding (including history of fistulae, GI perforation, or intra-abdominal abscess) within 6 months of initiation of study treatment.
Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding