EO-3021 for Gastrointestinal Cancer

Recruiting at 21 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Elevation Oncology

Must not be taking: Auristatin ADCs

Disqualifiers: Pregnancy, Brain metastases, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment for adult patients with solid tumors that have a specific marker called CLDN18.2. The treatment aims to find and destroy cancer cells with this marker. This approach helps target the cancer more precisely without affecting normal cells. CLDN18.2 has been identified as a promising target for cancer therapy, particularly in gastric cancer.

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.

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

My cancer is in an advanced stage and likely to express a specific protein.

Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)

Have at least one measurable extra-cranial lesion as defined by RECIST v1.1

Exclusion Criteria

I have had a stem cell or organ transplant and am on ongoing immunosuppressive therapy.

I have been treated with specific antibody drugs for my cancer.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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).

Varies

Every 3 weeks

Dose Expansion

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

Varies

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

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?

Group I: EO-3021 in combination with ramucirimab Experimental Treatment 2 Interventions

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.

Group II: EO-3021 in combination with dostarlimab Experimental Treatment 2 Interventions

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 expresssing 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.

Group III: EO-3021 Monotherapy Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Elevation Oncology

Lead Sponsor

Trials

4

Recruited

350+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

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

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

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

Trials

6

Recruited

840+