Last updated: October 16, 2023
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Neoplasms
Treatment
EMB-09
Clinical Study ID
NCT05263180
EMB09X101
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing and able to provide signed and dated informed consent prior to anystudy-related procedures and willing and able to comply with all study procedures.
- Phase I subjects:
- Patients with histologically or cytologically confirmed locallyadvanced/metastatic solid tumors including but not limited to melanoma, non-smallcell lung cancer (NSCLC), triple negative breast cancer (TNBC), head and necksquamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), hepatocellularcarcinoma (HCC), gastric cancer (GC), endometrium cancer (EC), ovarian cancer (OC), renal cell carcinoma (RCC) and small cell lung cancer (SCLC), colorectalcancer (CRC).
- Patients who have failed (progressed on, or are intolerant of) standard therapiesor 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 ifarchival tumor sample is not available. Archival tumor sample must be taken <2 yearsprior 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
Exclusion Criteria:
- 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) priorto study treatment;
- Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, ororganizing 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 30days of the first dose of study treatment.
- Any other serious underlying medical conditions
- Abuse of alcohol, cannabis-derived products, or other drugs.
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: EMB-09
Phase: 1
Study Start date:
July 25, 2022
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Peninsula and South Eastern Haematology & Oncology Group
Frankston,
AustraliaActive - Recruiting
GenesisCareNorthShore
Leonards Hill,
AustraliaActive - Recruiting
Blacktown Hospital
Sydney,
AustraliaActive - Recruiting
FUSCC
Shanghai,
ChinaActive - Recruiting
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