A Phase II Study of PD-1/IL-2α-bias Bispecific Antibody Fusion Protein Monotherapy in Advanced Es… (NCT07688291) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of PD-1/IL-2α-bias Bispecific Antibody Fusion Protein Monotherapy in Advanced Esophageal Squamous Cell Carcinoma After Failure of Prior ICI Plus Platinum-Based Chemotherapy
China40 participantsStarted 2026-06-30
Plain-language summary
Effective later-line treatment options remain an unmet medical need for patients with advanced esophageal squamous cell carcinoma (ESCC) whose disease has progressed after prior immunotherapy, particularly given the widespread use of immunotherapy in the first-line setting. This study is designed to evaluate the efficacy and safety of PD-1/IL-2α-bias bispecific antibody fusion protein monotherapy in patients with advanced or metastatic ESCC after failure of prior immune checkpoint inhibitor (ICI) plus platinum-based chemotherapy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)
. Disease progression or treatment failure after prior immune checkpoint inhibitor (ICI) plus platinum-based chemotherapy
. At least one measurable lesion according to RECIST version 1.1;
. ECOG PS 0 to 1;
. Age 18 to 75 years
. 6.Life expectancy of ≥12 weeks.
. Signed informed consent prior to study entry and willingness/ability to comply with study treatment, visits, and other protocol-specified procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: The first tumor assessment will be performed 7 weeks (±7 days) after the first dose; thereafter, tumor assessments will be performed every 6 weeks (±7 days) until 1 year (54 weeks), and then every 12 weeks (±7 days) thereafter
. Histology showing mixed squamous cell carcinoma, including but not limited to adenosquamous carcinoma, squamous cell carcinoma with small cell carcinoma components, carcinosarcoma, or sarcomatoid carcinoma.
. Concurrent participation in another interventional clinical study, except for observational (non-interventional) studies or the follow-up phase of an interventional study.
. Has received any treatment that is explicitly prohibited by the protocol.
. Subjects with unresolved \> Grade 1 toxicity associated with any prior antineoplastic therapy, with the exception of persistent Grade 2 alopecia, anemia, peripheral neuropathy, correctable electrolyte abnormalities, or stable endocrine abnormalities controlled with hormone replacement therapy.
. Prior immune checkpoint inhibitor therapy permanently discontinued due to severe immune-related toxicity.
. Clinically significant physical examination findings or laboratory abnormalities that, in the investigator's judgment, may interfere with study results or increase the risk of treatment-related complications.
. Women who are pregnant or lactating
. Active autoimmune disease or history of autoimmune disease