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

July 6, 2026 updated by: Beijing GoBroad Hospital

A Prospective, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of PD-1/IL-2α-bias Bispecific Antibody Fusion Protein Monotherapy in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitor Plus Platinum-Based Chemotherapy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: PD-1/IL-2α-bias bispecific antibody fusion protein
PD-1/IL-2α-bias bispecific antibody fusion protein: administered according to protocol-defined procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate
Time Frame: Up to 24 months
Up to 24 months
Incidence of Adverse Events (AE)
Time Frame: Up to 24 months
Up to 24 months
Incidence of treatment-emergent adverse Events (TEAE)
Time Frame: Up to 24 months
Up to 24 months
Incidence of serious adverse events (SAE)
Time Frame: Up to 24 months
Up to 24 months
Progression Free Survival
Time Frame: Up to 24 months
Up to 24 months
Overall Survival
Time Frame: From date of first dose until the date of death from any cause, whichever came first, assessed up to 2 years after the last patient is enrolled.
From date of first dose until the date of death from any cause, whichever came first, assessed up to 2 years after the last patient is enrolled.
Incidence of treatment-related adverse Events (TRAE)
Time Frame: Up to 24 months
Up to 24 months
Incidence of Immune-related adverse Events (irAE)
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing GoBroad Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJGBYY-IIT-LCYJ-2026-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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