For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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.
  2. 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.
  4. 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.
  5. ECOG performance status 0 or 1; life expectancy > 3 months.
  6. Adequate organ function to participate in the trial.
  7. Recovery from adverse events (AEs) related to prior anticancer therapy.
  8. Highly effective contraception

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Patients who have active autoimmune disease or history of autoimmune disease
  2. History of severe irAE.
  3. History of severe allergic reactions
  4. Use of systemic corticosteroids.
  5. Symptomatic central nervous system metastases.
  6. Patients with cardiac dysfunction
  7. Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)
  8. Prior treatment with TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR), CD40.
  9. Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
  10. Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia.
  11. Concurrent malignancy < 5 years prior to entry.
  12. Patients with active infections.
  13. Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment.
  14. Live virus vaccines < 30 days prior to screening
  15. Pregnant or breast-feeding females
  16. Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment.
  17. Any other serious underlying medical conditions
  18. Abuse of alcohol, cannabis-derived products, or other drugs.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +86-21-61043299Email iconEmail Study Center

Study Details


Contition

Advanced Solid Tumor

Age

18+

Phase

PHASE1

Participants Needed

30

Est. Completion Date

Dec 31, 2024

Treatment Type

INTERVENTIONAL


Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

ClinicalTrials.gov NCT Identifier

NCT05263180

Study Number

EMB09X101

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.