EO-3021 for Gastrointestinal Cancer

Recruiting at 19 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

120 Participants Needed

Trial Summary

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.

Research Team

Valerie Jansen, MD, PhD

Principal Investigator

Elevation Oncology, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Part B Expansion Experimental Treatment 1 Intervention

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

Group II: Part A: Escalation Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Elevation Oncology

Lead Sponsor

Trials

4

Recruited

350+