EO-3021 for Gastrointestinal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called EO-3021 (also known as SYSA1801) for advanced stomach cancer that cannot be surgically removed. The study aims to determine the optimal dose of EO-3021, either alone or with other drugs like ramucirumab or dostarlimab, for treating cancer with the specific protein CLDN18.2. It targets individuals whose cancer has spread or is inoperable and who have not succeeded with other treatments. Participants should have gastric or gastroesophageal junction adenocarcinoma that expresses this specific protein. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that EO-3021 is under study for treating advanced stomach and gastroesophageal junction (GEJ) cancers. Available safety information indicates that the most common side effects include nausea in 20% of patients and an increase in a liver enzyme in about 16.7% of patients. These side effects are considered manageable.
EO-3021 is also tested in combination with ramucirumab. Although detailed safety information for this combination isn't available yet, early research suggests that EO-3021 has promising anti-tumor effects.
Similarly, EO-3021 is studied with dostarlimab to explore its potential benefits. The FDA has granted EO-3021 "fast track" status, indicating promise in treating certain cancers.
Since these treatments are still in early trials, safety data remains limited. However, ongoing studies aim to determine the best doses and closely monitor any side effects to ensure participant safety as the trials continue.12345Why are researchers excited about this trial's treatments?
Researchers are excited about EO-3021 because it targets a specific protein called CLDN18.2, which is often found in gastric and gastroesophageal junction cancers. Unlike standard treatments like chemotherapy, EO-3021 can be used alone or in combination with other drugs like ramucirumab and dostarlimab, potentially offering more tailored and effective options. These combinations could enhance the immune system's ability to fight cancer cells more effectively. By focusing on this unique target, EO-3021 could provide a more precise treatment option, potentially leading to better outcomes for patients with fewer side effects.
What evidence suggests that this trial's treatments could be effective for gastrointestinal cancer?
Research has shown that EO-3021 may be a promising treatment for stomach and gastroesophageal junction cancer. Early results indicate that 42.8% of patients with tumors expressing the protein CLDN18.2 responded to the treatment. This trial tests EO-3021 in different treatment arms: as a monotherapy, in combination with ramucirumab, and in combination with dostarlimab. Researchers are exploring whether combining it with ramucirumab, a drug known to extend the lives of gastric cancer patients, enhances its effectiveness. EO-3021 is also being tested with dostarlimab, an immune therapy that has shown positive results in other cancers. These trials aim to build on the early signs that EO-3021 can combat tumors.12346
Who Is on the Research Team?
Valerie Jansen, MD, PhD
Principal Investigator
Elevation Oncology, Inc.
Are You a Good Fit for This Trial?
Adults with advanced or metastatic solid tumors likely to express CLDN18.2, such as stomach, pancreatic, and esophageal cancers. Participants must be over 18, have a good performance status (able to carry out daily activities), adequate organ function, and agree to use birth control. They should have tried standard treatments without success or cannot tolerate them.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose 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).
Dose Expansion
Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EO-3021
Trial Overview
The trial is testing EO-3021 in patients with certain types of cancer that are expected to show the presence of a protein called CLDN18.2. It's an early-phase study assessing how safe the drug is and how it affects these tumors.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received only one prior systemic therapy in the advanced metastatic setting will be treated with EO-3021 in combination with ramucirumab every 3 weeks to confirm RP2D.
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have not received any prior systemic therapies in the advanced metastatic setting will be treated with EO-3021 in combination with dostarlimab every 3 weeks to confirm RP2D.
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 monotherapy at various doses every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received one and no more than three lines of prior systemic therapy in the advanced metastatic setting will be randomized to one of two doses of EO-3021 dosed every 3 weeks to confirm RP2D.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elevation Oncology
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
CSPC Pharmaceutical Group Limited
Industry Sponsor
Citations
A phase I study of EO-3021 in adult patients with solid ...
In an ongoing Phase 1 study in China (NCT05009966), EO-3021 exhibited signs of anti-tumor activity in patients with gastric cancer and had an ...
2.
onclive.com
onclive.com/view/fda-grants-fast-track-status-to-eo-3021-for-cldn18-2-expressing-gastric-or-gej-cancerFDA Grants Fast Track Status to EO-3021 for CLDN18.2- ...
As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2–enriched subset of gastric and GEJ ...
Future Landscape of Anti-Claudin 18.2 Antibodies in Gastric ...
The most recent data presented show an ORR of 16.3% and a DCR of 48.8% in heavily pretreated patients receiving givastomig monotherapy. Patients ...
4.
clinicaltrials.gov
clinicaltrials.gov/study/NCT05980416?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Elevation%20Oncology%22))&rank=1Study of EO-3021 in Adult Patients With Solid Tumors ...
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with ...
5.
filecache.investorroom.com
filecache.investorroom.com/mr5ir_elevation_oncology_ir/274/download/ELEV%20EO-3021%20Initial%20Data%20from%20Phase%201%20Clinical%20Trial%20-%20Presentation.pdfInitial Data from Phase 1 Clinical Trial of EO-3021
32 patients enrolled into Phase 1 clinical trial, including 26 with gastric or GEJ cancer. • Study enrolled heavily pre-treated patient ...
Study of SYSA1801 in the Treatment of Claudin( CLDN) ...
This is an open-label, dose escalation, dose expansion and extension cohort phase 1 study to evaluate the safety, tolerability, pharmacokinetics and ...
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