A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
- Conditions
- Malignant Solid Tumor
- Registration Number
- JPRN-jRCT2031230438
- Lead Sponsor
- ozaki Akira
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Have measurable disease according to RECIST v1.1.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
- Must have acceptable organ and bone marrow function.
- Have a life expectancy of at least 3 months.
- Has clinically significant toxicities from previous anticancer therapies.
- Has rapidly progressing disease.
- Has a history of noninfectious pneumonitis/interstitial lung disease.
- Has a history of liver disease.
- Has had an allogeneic tissue/solid organ transplant or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042.
- Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
- Has had major surgery within 4 weeks before Screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the safety and tolerability of GEN1042 administered as monotherapy or in combination with pembrolizumab +- chemotherapy.
- Secondary Outcome Measures
Name Time Method