Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
- Conditions
- Neoplasms by SiteNeoplasmsDigestive System NeoplasmPancreas NeoplasmStomach NeoplasmGastrointestinal Neoplasms
- Interventions
- Registration Number
- NCT05980416
- Lead Sponsor
- Elevation Oncology
- Brief Summary
This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
Key
- 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
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Escalation EO-3021 Adult patients with select advanced unresectable or metastatic solid tumors likely to express CLDN18.2 will receive EO-3021 IV infusion at various doses every 3 weeks to determine MTD/RP2D(s). Part B Expansion EO-3021 Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.
- Primary Outcome Measures
Name Time Method Number of patients with treatment emergent adverse events From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) Number of patients with serious adverse events From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment The first 21-day treatment cycle for each patient enrolled in the Escalation Phase Number of patients with clinically significant changes to vital signs From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose Number of patients with clinically significant changes in laboratory tests From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Samsung Medical Center
🇰🇷Gangnam-Gu, Korea, Republic of
Yonsei University
🇰🇷Seodaemun-gu, Korea, Republic of
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
City of Hope
🇺🇸Duarte, California, United States
Yale - Smilow Cancer Hospital
🇺🇸New Haven, Connecticut, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Johns Hopkins University - Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
🇺🇸Orlando, Florida, United States
Henry Ford Cancer
🇺🇸Detroit, Michigan, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Atrium Health/Wake Forest University
🇺🇸Charlotte, North Carolina, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
UW Carbone Cancer Center - Cancer Connect
🇺🇸Madison, Wisconsin, United States
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital
🇯🇵Chuo Ku, Tokyo, Japan