A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements;

The age of signing the informed consent is 18 -70 years, regardless of gender;

Provide archived or fresh tumor tissue for vendor test;

At least one measurable lesion according to RECIST v1.1 criteria;

Disqualifiers

Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases;

Patients with uncontrolled tumor-related pain as determined by the investigator.

Moderate or severe ascites with clinical symptoms (i.e., those who required therapeutic puncture or drainage within 2 weeks before the study treatment, and only those who showed a small amount of ascites without clinical symptoms could be included in the study); Unable to control or moderate or higher amounts of pleural effusion or pericardial effusion

A history of gastrointestinal perforation and/or fistula within 6 months prior to initial medication, or significant tumor invasion of adjacent organs (large arteries or trachea, etc.), resulting in a higher risk of bleeding or fistula

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A2102;Adebrelimab;Cisplatin

    Drug

    Drug: SHR-A2102 Administration by intravenous infusion for a cycle of 3 weeks. Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks. Drug: Cisplatin Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

148 Participants
are divided into 1 treatment group
Group A: Treatment group A/BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RP2D

RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages;

Time frame
through phase IB completion, an average of 1 years
2

Incidence and severity of AE(DLT):

According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose;

Time frame
from Day1 to 90 days after last dose
3

ORR:

efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1

Time frame
18 months after the last subject was enrolled in the group

Secondary outcomes

1

DCR

Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;

Time frame
18 months after the last subject was enrolled in the group
2

DOR

Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;

Time frame
18 months after the last subject was enrolled in the group
3

PFS(Investigator evaluation)

Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;

Time frame
18 months after the last subject was enrolled in the group
4

OS(Investigator evaluation)

Since C1D1 and death from any cause;

Time frame
18 months after the last subject was enrolled in the group

Other outcomes

Sponsors and contacts

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