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

Primary Purpose

Pancreas Neoplasm, Stomach Neoplasm, Gastrointestinal Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EO-3021
Sponsored by
Elevation Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Neoplasm focused on measuring Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma, Esophageal Cancer, Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sarah Cannon Research InstituteRecruiting
  • Mary Crowley Cancer ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: Escalation

Part B Expansion

Arm Description

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).

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

Outcomes

Primary Outcome Measures

The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment
Number of patients with treatment emergent adverse events
Number of patients with serious adverse events
Number of patients with clinically significant changes to vital signs
Number of patients with clinically significant changes in laboratory tests

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
August 16, 2023
Sponsor
Elevation Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05980416
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elevation Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasm, Stomach Neoplasm, Gastrointestinal Neoplasms, Digestive System Neoplasm, Neoplasms by Site, Neoplasms
Keywords
Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma, Esophageal Cancer, Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Escalation
Arm Type
Experimental
Arm Description
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).
Arm Title
Part B Expansion
Arm Type
Experimental
Arm Description
Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.
Intervention Type
Drug
Intervention Name(s)
EO-3021
Intervention Description
Anti-Claudin 18.2 antibody drug conjugate
Primary Outcome Measure Information:
Title
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
Title
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)
Title
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)
Title
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
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Information
Phone
+1-716-371-1125
Email
medinfo@elevationoncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Jansen, MD, PhD
Organizational Affiliation
Elevation Oncology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Pelster, MD, MSCI
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minal Barve, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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