A Study of ES014 (Anti-CD39/TGF-β Bispecific Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

NCT05381935 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: ES014-1001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this first-in-human, open-label, multicenter, non-randomized study designed to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD), optimal biological dose (OBD), and recommended phase 2 dose (RP2D) of ES014 by evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary clinical activity of ES014 administered intravenously to subjects with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• The frequency and severity of adverse events of ES014

  Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. \[Time Frame: 1-3 years\]

  1-3 years

• Dose Limiting Toxicity of ES014

  Evaluation of dose-limiting toxicity (DLT)

  Assessed during first 28 days of treatment

• Optimal biological dose (OBD) of ES014

  The OBD of ES014 will be determined

  1-3 years

Secondary Outcomes (9)

• Maximum observed serum concentration (Cmax) of ES014

  1-3 years

• Trough observed serum concentration (Ctrough) of ES014

  1-3 years

• Area under the serum concentration time curve (AUC) of ES014

  1-3 years

• Time to Cmax (Tmax) of ES014

  1-3 years

• The terminal elimination half life of ES014

  1-3 years

Study Arms (2)

Part 1 dose escalation

EXPERIMENTAL

ES014 doses will be escalated in patients with advanced solid tumors with approximately 30 subjects.

Drug: ES014

Part 2 dose expansion

EXPERIMENTAL

Part 2 of the study will consist of 3 expansion cohorts for pancreatic ductal adenocarcinoma (Cohort 2A), NSCLC (Cohort 2B), and colorectal adenocarcinoma (Cohort 2C) with 10 subjects per expansion cohort respectively at the recommended optimal biological dose determined in Part 1 dose escalation.

Drug: ES014

Interventions

ES014 DRUG

ES014 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.

Part 1 dose escalation

Eligibility Criteria

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

You may qualify if:

• To be eligible for study entry, subjects must satisfy all of the following criteria:
• Capable of giving signed informed consent.
• Part 1: Histological or cytological documentation of unresectable locally advanced or metastatic solid tumors, if 1) disease has progressed despite standard therapy, and no further standard therapy exists; or 2) standard therapy has proven to be ineffective or intolerable.
• Part 2: Histological or cytological documentation of PDAC (Cohort 2A), CRC (Cohort 2B), or NSCLC (Cohort 2C), with unresectable locally advanced or metastatic disease, if 1) disease has progressed despite standard therapy, and no further standard therapy exists; or 2) standard therapy has proven to be ineffective or intolerable.
• Provide tumor tissue samples (minimum 10 unstained FFPE slides) obtained from the initial diagnosis to study entry.
• At least one measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
• Part 1: ECOG PS 0-1.
• Part 2: ECOG PS 0-2.
• Life expectancy of at least 12 weeks.
• Adequate hematologic, hepatic, renal and coagulation functions per protocol
• Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception

You may not qualify if:

• Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.
• Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.
• Prior treatment with the following therapies:
• Anticancer therapy within 30 days or 5 half-lives of the drug prior to the first dose of study drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered. Exception: hormonal and/or hormonal replacement therapy.
• A wash out of at least 2 weeks before the start of study drug for radiation to the extremities and 4 weeks for radiation to the chest, brain, or visceral organs is required.
• Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.
• Toxicity from previous anticancer treatment per protocol.
• Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug.
• Subjects who received transfusion of blood products (including platelets or red blood cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinant thrombopoietin within 14 days prior to the first dose of study treatment.
• Major surgery within 4 weeks prior to the first dose of study treatment.
• Live vaccine therapies within 4 weeks prior to the first dose of study treatment.
• Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment.
• Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES014.
• Invasive malignancy or history of invasive malignancy other than disease under study within the last two years per protocol.
• CNS metastases.

Sponsors & Collaborators

• Elpiscience Biopharma, Ltd.: lead

Study Officials

• Elpiscience Biopharma, Ltd.

  Elpiscience Biopharma, Ltd.

  STUDY DIRECTOR

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: May 11, 2022
• First Posted: May 19, 2022
• Study Start: April 21, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share