A Study of ES104 in Patients With Metastatic Colorectal Cancer

NCT05167448 | Active Not Recruiting Phase 1

• 1 other identifier: ES104-1001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this open-label, Multicenter Phase I/II study is to evaluate the safety, tolerability, preliminary anti-tumor efficay, pharmacokinetics, anti-drug antibodies and biomarkers of ES104 in patients with unresectable locally advanced or metastatic colorectal cancer who have failed systemic therapies.

Conditions

Metastatic Colorectal Cancer

Keywords

ES104

Outcome Measures

Primary Outcomes (2)

• Phase 1: The frequency and severity of adverse events of ES104

  The safety profile of ES104 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  1-3 years

• Phase 2: The anti-tumor activity of ES104

  The Objective Remission Rate (ORR) will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.

  2-5 years

Secondary Outcomes (10)

• Phase 1: Maximum observed serum concentration (Cmax) of ES104

  1-3 years

• Phase 1:Time to Cmax (Tmax) of ES104

  1-3 years

• Phase 1:Area under the serum concentration time curve (AUC) of ES104

  1-3 years

• Phase 1:The clearance of ES104

  1-3 years

• Phase 1: The immunogenicity of ES104

  1-3 years

Study Arms (3)

Cohort 1 Phase 1

EXPERIMENTAL

Drug: ES104

Cohort 2 Phase 1

EXPERIMENTAL

Drug: ES104

RP2D Phase 2

EXPERIMENTAL

Drug: ES104

Interventions

ES104 DRUG

ES104 is administered via Intravenous infusion, at dose of 10 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.

Cohort 1 Phase 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent form.
• Locally advanced or metastatic colorectal adenocarcinoma confirmed by pathology and not surgically resectable, having received systemic therapy and failed.
• At least one measurable lesion is required (RECIST v1.1)
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks.
• Adequate organ function, as assessed by the results of the laboratory tests specified in the protocol.
• Male and female subjects of childbearing potential must be willing to use effective contraceptive methods, from the time of signing informed consent and for the duration of study participation through 180 days following the last dose of study drug.

You may not qualify if:

• Receipt of any systemic antitumor therapy within 28 days prior to the first dose of study drug.
• Known history of severe allergy to any monoclonal antibody or study drug excipient.
• The subject has received or is receiving treatment in another clinical trial within 28 days prior to the first dose of study drug (except for participation in the overall survival follow-up of a study)
• Receipt of antiplatelet agents or anticoagulants for therapeutic purposes within 14 days prior to the first dose of study drug.
• Receipt of live vaccination within 28 days prior to the first dose of study drug.
• Prior history of allogeneic organ transplantation or allogeneic peripheral blood stem cell (PBSC)/bone marrow transplantation treatment.
• Subject has not recovered from all AEs of previous anticancer therapies to baseline or ≤ Grade 1 per CTCAE v5.0 before the first dose of study drug. Certain exceptions as defined in protocol apply.
• Subjects with active metastatic brain or meningeal metastases.
• Patients with other primary malignancies within 5 years before the first dose of study drug. Some exceptions as defined per protocol apply.
• Major surgery or major traumatic injury within 28 days prior to the first dose of study drug (in the judgment of the Investigator).
• History of cardiovascular disease as defined by the protocol within the past 5 years.
• History of bleeding-related illness as defined by the protocol.
• Presence of severe, unhealed or open wounds and active ulcers or untreated fractures.
• Known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome.
• Chronic active hepatitis B or active hepatitis C.

Sponsors & Collaborators

• Elpiscience (Suzhou) Biopharma, Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 22, 2021
• Study Start: February 25, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)