A Study of ES104 in Patients With Metastatic Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Jul 31, 2026
  • participants needed
    58
  • sponsor
    Elpiscience (Suzhou) Biopharma, Ltd.
Updated on 13 April 2022

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.

Details
Condition Metastatic Colorectal Cancer
Treatment ES104
Clinical Study IdentifierNCT05167448
SponsorElpiscience (Suzhou) Biopharma, Ltd.
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Active infection requiring systemic therapy 14 days prior to first dose of study drug
Pregnant or nursing females
Known history of alcohol or drug abuse
Subjects with comorbidities or other conditions that may affect compliance with the protocol or are not suitable for participation in this study in the judgment of the Investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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