A study to test how well different doses of BI 3706674 are tolerated by people with advanced cancer in the stomach and oesophagus

JRCT ID: jRCT2030230343

Registered date:12/09/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: GAC, EAC, and GEJAC solid tumours with KRAS wt amplification, Solid tumours of any histology
• Date of first enrollment: 25/10/2023
• Target sample size: 15
• Countries of recruitment: Korea,Japan,Taiwan,Japan,America,Japan
• Study type: Interventional
• Intervention(s): Patients will receive BI 3706674 once daily oral administration

Outcome(s)

• Primary Outcome: Occurrence of DLTs in the MTD evaluation period
• Secondary Outcome: to document the safety and tolerability of BI 3706674, to characterise pharmacokinetics, and to evaluate preliminary efficacy signals.

Key inclusion & exclusion criteria

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

Include criteria

- Patients with pathologically confirmed diagnosis of locally advanced or metastatic GAC, EAC, and GEJAC with KRAS wt amplification and documented disease progression despite at least 1 line of prior therapy
Dose escalation part only: Patients with advanced or metastatic relapsed or refractory solid tumours of any histology with KRAS wt amplification or harbouring a KRAS G12V mutation who have exhausted treatment options known to prolong survival for their disease.
- At least one target lesion that can be measured per RECIST version 1.1 (radiated lesions do not qualify as target lesions unless there has been demonstrated progression of the lesion after completion of radiotherapy)
Dose escalation part only: Patients with no lesions measurable per RECIST version 1.1 may be included if agreed between sponsor and investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Dose confirmation part only: Willingness to undergo pre- and on-treatment tumour biopsies
- Adequate organ function as defined in Section 3.3.2.
- All toxicities related to previous anti-cancer therapies have resolved to <= CTCAE Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be <= CTCAE Grade 2 and amenorrhea or menstrual disorders which can be any grade)

Exclude criteria

- Previous anti-cancer chemotherapy within 3 weeks of the first administration of trial drug
- Previous anti-cancer hormonal treatment or anti-cancer immunotherapy within 2 weeks of the first administration of trial drug
- Previous treatment with RAS, MAPK or SOS1 targeting agents

Related Information

• Primary Sponsor: Nakahara Asuka