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
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
NCT #
NCT05980416
Condition(s)
Esophageal, Gastric, Gastric/GEJ (Gastroesophageal Junction)/Esophageal, Non-Small Cell Lung, Ovarian, Pancreatic, Solid Tumors
Molecular Target(s)
CLDN18.2
Drug Classification(s)
Antibody Drug Conjugate
Agents(s)
EO-3021
Phase(s)
I
Mechanism of Action
EO-3021 is an anti-CLDN18.2 antibody drug conjugate.
Purpose
- How much of the study can be given with an acceptable level of side effects
- The effects of the study (good and bad)
- How much of the study is absorbed into the blood and how fast it is removed
- How the study is acting on your body
- Whether proteins in the blood and tissue samples can predict if someone has a better or worse response to the study agent
- 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
- 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
- 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 monoclonocal 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
Have previously received CLDN18.2 antibody drug conjugates (ADCs) and any ADC containing an auristatin payload
Location
MCD
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