EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

Part of paid clinical trials in Houston, Texas.

Sponsor
Shanghai EpimAb Biotherapeutics Co., Ltd.
Study ID
NCT05176665
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Gastrointestinal Carcinoid Tumor
  • Neoplasm Metastasis
  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EMB-01 — DRUG
    EMB-01 at the RP2D of 1600 mg will be administered as an IV infusion once weekly (QW) throughout the study. One cycle is defined as 4 weeks (4 doses).

Study Details

This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.

Key Dates

Start date
Oct 21, 2021
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
152 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib and Phase II
    The study will consist of Phase Ib and Phase II. The study is planning to recruit approximately 152 patients in total for advanced/metastatic GI cancers, which include 24 patients in Phase Ib and up to approximately 128 patients in Phase II. For GC, HCC, and BTC groups, up to approximately 24 patients may be enrolled in Phase Ib and Phase II. For CRC group, up to approximately 80 patients may be enrolled in Phase Ib and Phase II with up to 40 patients in each subgroup.

Primary Outcome Measure

Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 [ Time Frame: Phase 1b, screening up to follow-up (30 days after the last dose) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Michael Lee

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

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