Actively Recruiting
Study of SHR-A2102 With Adebrelimab, With or Without Cisplatin, in Advanced or Metastatic Esophageal Cancer Open-Label Phase IB/II Trial Evaluating Safety and Efficacy Conducted by Shanghai Hengrui Pharmaceutical Co., Ltd.
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2025-01-03
148
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of SHR-A2102 combined with Adebrelimab, with or without other antitumor therapies, in adults with advanced or metastatic esophageal cancer. The study aims to find the best dose of SHR-A2102 for this condition. This is a Phase IB/II open-label study involving multiple centers, focusing on patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma. The treatments include intravenous infusions of SHR-A2102, Adebrelimab, and Cisplatin, each given on a 3-week cycle. Participants may receive SHR-A2102 with Adebrelimab alone or with additional antitumor therapy depending on their treatment group. The study monitors the participants through initial treatment phases and evaluates responses over time. Participants will undergo various assessments to track treatment effects, including monitoring side effects from the start of treatment until 90 days after the last dose, and measuring response rates up to 18 months after enrollment. Safety and tolerability are continuously evaluated, with follow-up lasting about one year after treatment. Researchers also review patient survival expectations, organ function, and overall health throughout the study.
CONDITIONS
Official Title
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and follow the treatment and testing plan
- Age between 18 and 70 years, any gender
- Provide archived or fresh tumor tissue for testing
- Have at least one measurable tumor lesion by RECIST v1.1 criteria
- Diagnosed with locally advanced unresectable or metastatic esophageal squamous cell carcinoma
- ECOG performance status of 0 or 1
- Expected survival of 12 weeks or more
- Good organ function
- Use effective contraception if sexually active and of reproductive potential
You will not qualify if you...
- Untreated or uncontrolled active central nervous system metastases
- Uncontrolled tumor-related pain
- Moderate or severe ascites needing recent drainage or significant pleural/pericardial effusion
- History of gastrointestinal perforation or fistula within 6 months
- Prior antitumor therapy within 4 weeks before study start
- Previous antibody drugs with topoisomerase I inhibitors
- Use of certain enzyme boosters or inducers within 5 drug half-lives before first dose
- Recent major surgeries or expected elective surgeries during the study
- Recent radiation therapy above specified doses before dosing
- Ongoing toxicity from prior treatments above grade 1
- Recent live attenuated vaccines
- Recent immunosuppressive therapy
- Known or suspected interstitial pneumonia
- Significant recent blood loss
- Severe cardiovascular or cerebrovascular disease
- Recent arterial or venous thrombosis
- Other malignancies
- Severe infections within 28 days before dosing
- Active hepatitis B or C
- Active pulmonary tuberculosis within 1 year
- History of immune deficiency
- Severe allergy to study drugs
- Other conditions increasing risk or interfering with study participation per investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
Z
Zongyan Xie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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