Experimental fusion protein aims to re-engage immune system against tough esophageal cancer
NCT ID NCT07688291
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This phase 2 trial tests a single drug called PD-1/IL-2α-bias bispecific antibody fusion protein in people with advanced or metastatic esophageal squamous cell carcinoma whose cancer worsened after prior immunotherapy and chemotherapy. The drug is designed to boost the immune system's ability to attack cancer cells. The study will measure how many patients respond, how long they live, and what side effects occur.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1/IL-2α-bias bispecific antibody fusion protein
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced esophageal cancer who have run out of standard therapies.
- What could go wrong
- This is an early phase 2 trial with only 40 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) 2. Disease progression or treatment failure after prior immune checkpoint inhibitor (ICI) plus platinum-based chemotherapy 3. At least one measurable lesion according to RECIST version 1.1; 4. ECOG PS 0 to 1; 5. Age 18 to 75 years 6. 6.Life expectancy of ≥12 weeks. 7. Signed informed consent prior to study entry and willingness/ability to comply with study treatment, visits, and other protocol-specified procedures 8. Adequate organ function 9. Women of childbearing potential, or male patients whose sexual partners are women of childbearing potential, must use effective contraception throughout the treatment period and for 180 days after the last dose of study drug. Exclusion Criteria: 1. 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. 2. Concurrent participation in another interventional clinical study, except for observational (non-interventional) studies or the follow-up phase of an interventional study. 3. Has received any treatment that is explicitly prohibited by the protocol. 4. 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. 5. Prior immune checkpoint inhibitor therapy permanently discontinued due to severe immune-related toxicity. 6. 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. 7. Women who are pregnant or lactating 8. Active autoimmune disease or history of autoimmune disease 9. Known positive HIV test, active hepatitis B, hepatitis C (HCV), tuberculosis, or a history of these infections. 10. Clinically significant cardiovascular or cerebrovascular disease. 11. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring corticosteroid therapy, or any clinically evident active interstitial lung disease; idiopathic pulmonary fibrosis identified on baseline CT scan; or uncontrolled massive pleural effusion or pericardial effusion. 12. Uncontrolled or unstable intercurrent illness 13. For subjects with uncontrolled epilepsy, central nervous system disease, or mental illness, the investigator should assess whether such conditions may impair the subject's ability to provide informed consent or comply with the study protocol. 14. Poor gastrointestinal function, malabsorption syndrome, or active gastrointestinal ulcer. 15. History of organ transplantation or allogeneic hematopoietic stem cell transplantation. 16. Congenital or acquired immunodeficiency. 17. Severe malnutrition requiring parenteral nutrition support, except for malnutrition corrected for more than 4 weeks before the first dose of study treatment. 18. Uncontrolled metabolic disorder or other non-malignant organic/systemic disease or secondary effect of cancer that may result in high medical risk and/or uncertainty in survival assessment. 19. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or higher cirrhosis. 20. History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, chronic diarrhea, or any other acute/chronic disease, psychiatric disorder, or laboratory abnormality that may increase study risk, interfere with interpretation of results, or, in the investigator's judgment, make the patient unsuitable for study participation. 21. Another pathologically confirmed malignancy diagnosed within 5 years before the first dose, except for curatively treated basal-cell carcinoma of the skin, squamous-cell carcinoma of the skin, and/or carcinoma in situ after curative resection, localized prostate cancer after radical treatment, papillary thyroid carcinoma, and other malignancies that have been curatively treated, have had no known active disease for at least 2 years before study entry, and have an extremely low risk of recurrence. 22. Interstitial pneumonitis, pulmonary fibrosis, pneumoconiosis, drug-related pneumonitis, radiation pneumonitis, or other pulmonary conditions requiring corticosteroids or other treatment; history of severely impaired pulmonary function or other forms of restrictive lung disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206, China