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New treatment option for Advanced/Metastatic Solid Tumors
Official title First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
ClinicalTrials.gov ID: NCT05607498
What this study is testing
What is EMB07?
EMB07 is an investigational medicine, being studied as a potential treatment for advanced/metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 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-07 will also be assessed.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Male or female, and aged ≥ 18 years
- Treatment group A: Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative...
- Treatment group A: Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or...
- Patients must provide archival tumor samples, or a biopsy will be required if archival tumor sample is not available. Archival tumor sample must be...
You likely can't join if
- Prior treatment with any agent targeting ROR1.
- History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.
- Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with solid tumors with CNS metastases are...
- Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment.
- Abuse on alcohol, cannabis-derived products, or other drugs.
See the full eligibility criteria
- 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.
- Male or female, and aged ≥ 18 years
- Treatment group A: Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative breast cancer, lung adenocarcinoma, ovarian cancer, pancreatic...
- Treatment group A: Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or evaluable disease per RECIST V1.1. Treatment group B: Presence of at least...
- Patients must provide archival tumor samples, or a 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...
- ECOG performance status 0 or 1
- Adequate organ function to participate in the trial.
- Recovery from adverse events (AEs) related to prior anticancer therapy.
- Prior treatment with any agent targeting ROR1.
- History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.
- Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with solid tumors with CNS metastases are eligible if they do not need to receive local radiation treatment at the...
- Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment.
- Abuse on alcohol, cannabis-derived products, or other drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Frankston, Victoria, Australia
- Nedlands, Western Australia, Australia
- Changsha, Hunan, China
- Baoding, China
- Beijing, China
- Bengbu, China
- Guangzhou, China
- Harbin, China
- Shandong, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frankston, Victoria, Australia; Nedlands, Western Australia, Australia; Changsha, Hunan, China; Baoding, China; Beijing, China; Bengbu, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.