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Study of Combination Therapies in Esophageal Cancer
EU CTIS ID: 2023-505189-26-00
What this study is testing
1. Safety Lead-In Phase: To evaluate the safety and tolerability of combination treatments that have not been evaluated in a separate study. 2. To estimate the objective response rate (ORR) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC).
- Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immuneoncology (IO) therapy.
- Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice.
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
You likely can't join if
- Direct invasion into adjacent organs such as the aorta or trachea.
- Clinically significant cardiovascular disease within 12 months from first dose of study intervention.
- Has risk for significant GI bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization.
- Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy.
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
See the full eligibility criteria
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC).
- Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immuneoncology (IO) therapy.
- Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice.
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
- Direct invasion into adjacent organs such as the aorta or trachea.
- Clinically significant cardiovascular disease within 12 months from first dose of study intervention.
- Has risk for significant GI bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization.
- Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy.
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Participants with human immunodeficiency virus (HIV) with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- History of allogenic tissue/solid organ transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Turkey
- Brazil
- Korea, Republic of
- Taiwan
- United States
- Japan
- Singapore
- Chile
- Switzerland
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Turkey; Brazil; Korea, Republic of; Taiwan; United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.