Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
- Conditions
- Solid Tumor
- Registration Number
- JPRN-jRCT2031230637
- Lead Sponsor
- Jansen Valerie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)
- Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as gastric/GEJ, pancreatic and esophageal cancer
- >= 18 years of age
- ECOG performance status (PS) 0 or 1 at Screening
- Progressed on or after standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy
- Have at least one measurable extra-cranial lesion as defined by RECIST v1.1
- Adequate organ function
- Life expectancy > 12 weeks
- Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent
- Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion
- Pregnant or breastfeeding
- Symptomatic or untreated brain metastases
- Have previously received CLDN18.2 antibody drug conjugates (ADCs) or any ADC containing an auristatin payload (prior monoclonal antibody against CLDN18.2 may be eligible)
- Have peripheral neuropathy Grade >= 2
- Have history of non-infectious pneumonitis/interstitial lung disease
- Have diagnosis of another malignancy, or history of systemic treatment for invasive cancer within last 3 years. Note: Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. Diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or noninvasive tumor does not affect eligibility
- Have active ocular surface disease at baseline (based on screening ophthalmic examination)
- Have serious concurrent illness or clinically relevant active bacterial, fungal or viral infection
- Have previous hypersensitivity to any known components of EO-3021 or history of severe infusion reaction or hypersensitivity (CTCAE Grade 3 or higher) with monoclonal antibody treatment
- Clinically significant cardiac disease, including but not limited to symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 6 months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes)
- Have history of allogenic hematopoietic stem cell transplantation or solid organ transplantation with ongoing systemic immunosuppressive therapy
- Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the Investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method