Clinical trial NCT05980416: Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
Official title: A Phase 1 Dose Escalation and Expansion Study of EO-3021, an Anti-claudin 18.2 (CLDN18.2) Antibody Drug Conjugate, in Patients With Solid Tumors Likely to Express CLDN18.2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pancreas Neoplasm
Stomach Neoplasm
Gastrointestinal Neoplasms
Digestive System Neoplasm
Neoplasms by Site
Neoplasms
Keywords: Gastric Cancer
Gastroesophageal Junction (GEJ) Adenocarcinoma
Esophageal Cancer
Pancreatic Cancer
Lead sponsor: Elevation Oncology
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Primary outcomes:
measure: The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment
timeFrame: The first 21-day treatment cycle for each patient enrolled in the Escalation Phase
measure: Number of patients with treatment emergent adverse events
timeFrame: 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)
measure: Number of patients with serious adverse events
timeFrame: 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)
measure: Number of patients with clinically significant changes to vital signs
timeFrame: 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
measure: Number of patients with clinically significant changes in laboratory tests
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: New Haven
country: United States
facility: Yale - Smilow Cancer Hospital
state: Connecticut
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Johns Hopkins University - Sibley Memorial Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Orlando
country: United States
facility: Sarah Cannon Research Institute at Florida Cancer Specialists
state: Florida
city: Detroit
country: United States
facility: Henry Ford Cancer
state: Michigan
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health/Wake Forest University
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: UW Carbone Cancer Center - Cancer Connect
state: Wisconsin
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center
city: Seodaemun-gu
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Elevation Oncology, Inc.
name: Valerie Jansen, MD, PhD
role: STUDY_DIRECTOR
References: