A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.

NCT05263180 | Unknown Phase 1

• 1 other identifier: EMB09X101
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief Summary

This study is to evaluate the safety and tolerability of EMB-09 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-09 will also be assessed.

Conditions

Advanced Solid Tumor

Keywords

Phase I; Bispecific antibody; OX40; PD-L1; EMB-09; Immuno-oncology; dose escalation; cohort expansion; advanced solid tumor

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of adverse events as assessed by CTCAE V5.0

  Incidence and severity of AE.

  Screening up to 30 days after the last dose.

• Incidence of serious adverse events. (SAE)

  Incidence of SAE.

  Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.

• Incidence of dose interruptions.

  Incidence of dose interruptions of EMB-09 during treatment as a measure of tolerability.

  Screening up to 30 days after the las dose.

• Dose intensity.

  Actual amount of drug taken by patients divided by the planned amount.

  Screening up to 30 days after the last dose.

• The incidence of DLTs during the first cycle of treatment.

  The dose limiting toxicities are based on drug related adverse events and are specifically defined in study protocol.

  First infusion to the end of cycle 1. (each cycle is 28 days)

Secondary Outcomes (10)

• Overall response rate

  From the date of dosing until the date of first documented progression or date of death from any cause, whichever case first, expected average 6 months.

• Area under the serum concentration-time curve (AUC) of EMB-09

  Through treatment until EOT visit, expected average 6 months

• Maximum serum concentration (Cmax) of EMB-09

  Through treatment until EOT visit, expected average 6 months

• Trough concentration (Ctrough) of EMB-09

  Through treatment until EOT visit, expected average 6 months

• Average concentration over a dosing interval (Css, avg)of EMB-09.

  Through treatment until EOT visit, expected average 6 months

Study Arms (1)

Experimental: EMB-09

EXPERIMENTAL

Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels.

Biological: EMB-09

Interventions

EMB-09 BIOLOGICAL

EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.

Experimental: EMB-09

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
• Phase I subjects:
• Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors including but not limited to melanoma, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), hepatocellular carcinoma (HCC), gastric cancer (GC), endometrium cancer (EC), ovarian cancer (OC), renal cell carcinoma (RCC) and small cell lung cancer (SCLC), colorectal cancer (CRC).
• Patients who have failed (progressed on, or are intolerant of) standard therapies or no available standard treatment
• Measurable or evaluable disease per RECIST v1.1.
• Patients must provide archival tumor, or a fresh tumor biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken \<2 years prior to screening, otherwise a fresh tumor biopsy at screening is required.
• ECOG performance status 0 or 1; life expectancy \> 3 months.
• Adequate organ function to participate in the trial.
• Recovery from adverse events (AEs) related to prior anticancer therapy.
• Highly effective contraception

You may not qualify if:

• Patients who have active autoimmune disease or history of autoimmune disease
• History of severe irAE.
• History of severe allergic reactions
• Use of systemic corticosteroids.
• Symptomatic central nervous system metastases.
• Patients with cardiac dysfunction
• Uncontrolled diabetes mellitus with hemoglobin A1c \> 8% (via medical history)
• Prior treatment with TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR), CD40.
• Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
• Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia.
• Concurrent malignancy \< 5 years prior to entry.
• Patients with active infections.
• Major surgery \< 4 weeks or minor surgery \< 2 weeks prior to study treatment.
• Live virus vaccines \< 30 days prior to screening
• Pregnant or breast-feeding females

Sponsors & Collaborators

• Shanghai EpimAb Biotherapeutics Co., Ltd.: lead

Study Sites (4)

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Australia

RECRUITING

GenesisCareNorthShore

Leonards Hill, Australia

RECRUITING

Blacktown Hospital

Sydney, Australia

RECRUITING

FUSCC

Shanghai, China

RECRUITING

Central Study Contacts

Shuqi Zeng, MD.

CONTACT

+86-21-61043299; shqzeng@epimab.com

Di Hu

CONTACT

+86-21-61043299; xyang@epimab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment Dose escalation followed by Cohort Expansion Phase at the RP2D.

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 2, 2022
• Study Start: July 25, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CN (1)