A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.
NCT ID: NCT05263180
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2022-07-25
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: EMB-09
Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels.
EMB-09
EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.
Interventions
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EMB-09
EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.
Eligibility Criteria
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Inclusion Criteria
* Phase I subjects:
1. 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).
2. Patients who have failed (progressed on, or are intolerant of) standard therapies or no available standard treatment
3. 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
Exclusion Criteria
* 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
* Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment.
* Any other serious underlying medical conditions
* Abuse of alcohol, cannabis-derived products, or other drugs.
18 Years
ALL
No
Sponsors
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Shanghai EpimAb Biotherapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peninsula and South Eastern Haematology & Oncology Group
Frankston, , Australia
GenesisCareNorthShore
Leonards Hill, , Australia
Blacktown Hospital
Sydney, , Australia
FUSCC
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Vinod Ganju
Role: primary
Adrian Lee
Role: primary
Jian Zhang
Role: primary
Other Identifiers
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EMB09X101
Identifier Type: -
Identifier Source: org_study_id
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