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Advanced or Metastatic Esophageal CancerPhase 1/2NCT06474468

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

A Phase 1/2 study testing SHR-A2102；Adebrelimab；Cisplatin in people with Advanced or Metastatic Esophageal Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced or Metastatic Esophageal Cancer
What is being tested?
SHR-A2102；Adebrelimab；Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteChina
Study dates
20 Jun 2024to Oct 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
  • Subjects with pathology confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma;
  • The ECOG score is 0 or 1；
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  • Expected survival ≥12 weeks
  • Good level of organ function
  • Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Who cannot join

  • 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
  • Have antitumor therapy was received 4 weeks before the start of the study；
  • Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors
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  • Systemic antitumor therapy was received 4 weeks before the start of the study
  • Treatment with CYP3A4, CYP2D6, P-gp, or BCRP booster or inducer is less than 5 drug half-lives from the date of first administration
  • Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period;
  • Perform non-chest radiation therapy with >30Gy within 28 days before dosing, chest radiation therapy with >30Gy within 24 weeks before first dosing, and radiation therapy with ≤30Gy within 14 days before first dosing
  • Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria
  • Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；
  • Systemic immunosuppressive therapy was administered within 14 days prior to the first study
  • Subjects with known or suspected interstitial pneumonia;
  • In the first study, a single blood loss ≥50ml or a cumulative daily blood loss ≥300m occurred within 1 month before medication
  • Subjects with severe cardiovascular and cerebrovascular disease;
  • Arterial/venous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months prior to initial administration
  • Had been diagnosed with any other malignancy
  • Subjects who had a severe infection within 28 days prior to the first dose
  • Active hepatitis B or active hepatitis C
  • Patients with active pulmonary tuberculosis within 1 year prior to enrolment
  • History of immune deficiency
  • Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, or other monoclonal antibody/fusion protein drugs
  • Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Trial locations and contacts

1 site in 1 country.

Zongyan Xie contact

0518-82342973

zongyan.xie.zx3@hengrui.com

China1 site, 1 recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Jinming Yu

    Recruiting

Other trials in China

About this study

Official title: A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer

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

Being tested
SHR-A2102；Adebrelimab；Cisplatin
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • SHR-A2102；Adebrelimab；CisplatinDrug

    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.

Study groups in NCT06474468
Study groupRoleWhat they receive
Treatment group A/BExperimentalA：SHR-A2102+Adebrelimab B：SHR-A2102+Adebrelimab+Cisplatin
Receives: Drug: SHR-A2102；Adebrelimab；Cisplatin

What is being measured

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

  1. RP2D

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

    Measured: 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；

    Measured: 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

    Measured: 18 months after the last subject was enrolled in the group

Secondary outcomes (4)

  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；

    Measured: 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；

    Measured: 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；

    Measured: 18 months after the last subject was enrolled in the group

  4. OS(Investigator evaluation)

    Since C1D1 and death from any cause；

    Measured: 18 months after the last subject was enrolled in the group

Timeline

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

  1. First posted25 Jun 2024
  2. Study start20 Jun 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474468
Sponsor's protocol ID
SHR-A2102-203
Status last verified
Jun 2024
First submitted
6 Jun 2024
Last updated
3 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A2102；Adebrelimab；Cisplatin in people with Advanced or Metastatic Esophageal Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. 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 24 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: status not confirmed, as of the sponsor's last update on 3 Jan 2025. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

Contact Zongyan Xie (0518-82342973, zongyan.xie.zx3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: through phase IB completion, an average of 1 years). The study lists 3 primary outcomes in all. 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 NCT06474468.

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 3 Jan 2025.

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