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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EO-3021 — DRUG
  Anti-Claudin 18.2 antibody drug conjugate
• Ramucirumab (CYRAMZA®) — DRUG
  VEGFR2 inhibitor
• Dostarlimab — DRUG
  anti-PD-1 antibody

Study Details

This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.

Key Dates

Start date

Aug 10, 2023

Status verified

Oct 2025

Primary completion

May 7, 2025

Completion

Jun 2, 2025

Study Design

Enrollment

88 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: EO-3021 Monotherapy
  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.
• Experimental: EO-3021 in combination with ramucirumab
  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.
• Experimental: EO-3021 in combination with dostarlimab
  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.

Primary Outcome Measure

Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. [ 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) ]

Locations (16)

Find similar trials in Phoenix, AZ

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