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AzTrials

Esophageal Squamous Carcinoma CellPhase 2NCT07688291

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

A Phase 2 study testing PD-1/IL-2α-bias bispecific antibody fusion protein in people with Esophageal Squamous Carcinoma Cell, run by Beijing GoBroad Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Carcinoma Cell
What is being tested?
PD-1/IL-2α-bias bispecific antibody fusion protein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
30 Jun 2026to 30 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Signed informed consent prior to study entry and willingness/ability to comply with study treatment, visits, and other protocol-specified procedures
  • Adequate organ function
  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • Women who are pregnant or lactating
  • Active autoimmune disease or history of autoimmune disease
  • Known positive HIV test, active hepatitis B, hepatitis C (HCV), tuberculosis, or a history of these infections.
  • Clinically significant cardiovascular or cerebrovascular disease.
  • 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.
  • Uncontrolled or unstable intercurrent illness
  • 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.
  • Poor gastrointestinal function, malabsorption syndrome, or active gastrointestinal ulcer.
  • History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Congenital or acquired immunodeficiency.
  • Severe malnutrition requiring parenteral nutrition support, except for malnutrition corrected for more than 4 weeks before the first dose of study treatment.
  • 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.
  • Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or higher cirrhosis.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhihao Lu contact

+86-010-50847588

zhihaolupku@bjmu.edu.cn

China1 site

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 102206

    Zhihao Lu, +86-010-50847588, zhihaolupku@bjmu.edu.cn

Other trials in China

About this study

Official title: 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.

Being tested
PD-1/IL-2α-bias bispecific antibody fusion protein
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1/IL-2α-bias bispecific antibody fusion proteinDrug

    PD-1/IL-2α-bias bispecific antibody fusion protein: administered according to protocol-defined procedure

Study groups in NCT07688291
Study groupRoleWhat they receive
Single ArmExperimentalNot described
Receives: Drug: PD-1/IL-2α-bias bispecific antibody fusion protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured: 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 outcomes (8)

  1. Disease Control Rate

    Measured: Up to 24 months

  2. Progression Free Survival

    Measured: Up to 24 months

  3. Overall Survival

    Measured: 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.

  4. Incidence of Adverse Events (AE)

    Measured: Up to 24 months

  5. Incidence of treatment-emergent adverse Events (TEAE)

    Measured: Up to 24 months

  6. Incidence of treatment-related adverse Events (TRAE)

    Measured: Up to 24 months

  7. Incidence of Immune-related adverse Events (irAE)

    Measured: Up to 24 months

  8. Incidence of serious adverse events (SAE)

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07688291
Sponsor's protocol ID
BJGBYY-IIT-LCYJ-2026-030
Status last verified
Jun 2026
First submitted
5 Jun 2026
Last updated
7 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, Yang S, Fan Y, Shi J, Zhang X, Shen L, Shu Y, Wang C, Dai T, Mao T, Chen L, Guo Z, Liu B, Pan H, Cang S, Jiang Y, Wang J, Ye M, Chen Z, Jiang D, Lin Q, Ren W, Wang J, Wu L, Xu Y, Miao Z, Sun M, Xie C, Liu Y, Wang Q, Zhao L, Li Q, Huang C, Jiang K, Yang K, Li D, Liu Y, Zhu Z, Chen R, Jia L, Li W, Liao W, Liu HX, Ma D, Ma J, Qin Y, Shi Z, Wei Q, Xiao K, Zhang Y, Zhang Y, Chen X, Dai G, He J, Li J, Li G, Liu Y, Liu Z, Yuan X, Zhang J, Fu Z, He Y, Ju F, Liu Z, Tang P, Wang T, Wang W, Zhang J, Luo X, Tang X, May R, Feng H, Yao S, Keegan P, Xu RH, Wang F. Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial. Cancer Cell. 2022 Mar 14;40(3):277-288.e3. doi: 10.1016/j.ccell.2022.02.007. Epub 2022 Mar 3.

    PubMed 35245446

  • Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.

    PubMed 35440464

  • Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.

    PubMed 34519801

  • Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.

    PubMed 34454674

  • Rustgi AK, El-Serag HB. Esophageal carcinoma. N Engl J Med. 2014 Dec 25;371(26):2499-509. doi: 10.1056/NEJMra1314530. No abstract available.

    PubMed 25539106

  • Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.

    PubMed 39036382

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1/IL-2α-bias bispecific antibody fusion protein in people with Esophageal Squamous Carcinoma Cell, run by Beijing GoBroad Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhihao Lu (+86-010-50847588, zhihaolupku@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07688291, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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