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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

ConditionEsophageal Squamous Carcinoma Cell
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing GoBroad Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Disease Control Rate

Time frame
Up to 24 months
2

Progression Free Survival

Time frame
Up to 24 months
3

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.
4

Incidence of Adverse Events (AE)

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing GoBroad Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: