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

• ClinicalTrials.gov Identifier: NCT05980416
• Recruitment Status: Recruiting
• First Posted: August 8, 2023
• Last Update Posted: March 6, 2024
• Sponsor: Elevation Oncology
• Information provided by (Responsible Party): Elevation Oncology

Tracking Information

• First Submitted Date: July 31, 2023
• First Posted Date: August 8, 2023
• Last Update Posted Date: March 6, 2024
• Actual Study Start Date: August 10, 2023
• Estimated Primary Completion Date: September 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2023)

• The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment [ Time Frame: The first 21-day treatment cycle for each patient enrolled in the Escalation Phase ]
• Number of patients with treatment emergent adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pancreas Neoplasm
• Stomach Neoplasm
• Gastrointestinal Neoplasms
• Digestive System Neoplasm
• Neoplasms by Site
• Neoplasms

Intervention

Drug: EO-3021

Anti-Claudin 18.2 antibody drug conjugate

Study Arms

• 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).
  Intervention: Drug: EO-3021
• 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.
  Intervention: Drug: EO-3021

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 31, 2023): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2028
• Estimated Primary Completion Date: September 2028 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Medical Information; +1-716-371-1125; medinfo@elevationoncology.com

• Listed Location Countries: Japan, United States

Administrative Information

• NCT Number: NCT05980416
• Other Study ID Numbers: ELVCAP-002-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Elevation Oncology
• Original Responsible Party: Same as current
• Current Study Sponsor: Elevation Oncology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Valerie Jansen, MD, PhD; Elevation Oncology, Inc.

• PRS Account: Elevation Oncology
• Verification Date: March 2024