Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

Sponsor

Elevation Oncology (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05980416

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Neoplasm Stomach Neoplasm Gastrointestinal Neoplasms Digestive System Neoplasm Neoplasms by Site Neoplasms	Drug: EO-3021	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Escalation 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).	Drug: EO-3021 Anti-Claudin 18.2 antibody drug conjugate
Experimental: Part B Expansion Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.	Drug: EO-3021 Anti-Claudin 18.2 antibody drug conjugate

Arm

Intervention/Treatment

Experimental: Part A: Escalation

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).

Drug: EO-3021

Anti-Claudin 18.2 antibody drug conjugate

Experimental: Part B Expansion

Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.

Drug: EO-3021

Anti-Claudin 18.2 antibody drug conjugate

Outcome Measures

Primary Outcome Measures

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 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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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