AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma - LARVOL DELTA

Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR + / HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Harbin Medical University | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Efficacy and Safety of Adebrelimab Plus Chemotherapy as Neoadjuvant Treatment for Unresectable Locally Advanced Thymic Carcinoma (IASLC-WCLC 2025) - "Given the unmet clinical need for this rare malignancy, we conducted this study to evaluate the efficacy and safety of adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy for unresectable locally advanced thymic carcinoma. Conclusions : In patients with unresectable locally advanced thymic carcinoma, neoadjuvant adebrelimab combined with chemotherapy demonstrated promising efficacy and an acceptable safety profile. The trial is still ongoing to complete accrual in stage II."

Clinical • Metastases • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thymic Carcinoma • Thymus Cancer

A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Adebrelimab Beyond Progression Plus Chemotherapy or Targeted Therapy as Second-Line Treatment for Extensive-Stage Small Cell Lung Cancer (IASLC-WCLC 2025) - P3 | "Introduction : The phase III IMfirst study (EudraCT: 2019-002784-10) showed that compared with no follow-up therapy and other treatments, atezolizumab beyond progression tends to prolong overall survival. Twenty-four-point-four percent of patients in the ASTRUM-005 trial continued to receive serplulimab after disease progression, which may be one of the key factors contributing to a lower overall survival hazard ratio (HR) of non-head-to-head comparison to the IMpower133, CASPIAN, and CAPSTONE-1 trials (HR 0.62 vs 0.76, 0.71, 0.73, respectively)...The secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety. Additional indicators include the relationship between T-cell subpopulation typing and number and therapeutic efficacy and the relationship between nutritional indicators and therapeutic effectiveness."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: Yongjun Chen

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Adebrelimab plus Apatinib and Etoposide in the Treatment of HER2-Negative Breast Cancer Brain Metastasis: A Phase II Study (ESMO 2025) - No abstract available

P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P2 trial • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Adebrelimab Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Hebei Medical University Fourth Hospital | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Neoadjuvant Treatment of Locally Advanced Hypopharyngeal Cancer With Adebrelimab Combined With TP Chemotherapy Regimen (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

New P2 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Efficacy and safety of immunotherapy or antiangiogenic agent-based treatment strategies versus chemotherapy as first-line treatment for extensive-stage small cell lung cancer: a network meta-analysis. (PubMed, Front Pharmacol) - "Immune checkpoint inhibitors (ICIs) combined with etoposide-platinum are recommended as the standard first-line therapy for extensive-stage small cell lung cancer (ES-SCLC)...The drug combination patterns included ipilimumab, durvalumab, adebrelimab, atezolizumab, socazolimab, pembrolizumab, serplulimab, tislelizumab, toripalimab, durvalumab + tremelimumab, tiragolumab + atezolizumab, benmelstobart + anlotinib, bevacizumab + atezolizumab, anlotinib, bevacizumab in combination with chemotherapy...The toxicity of ICI + Antiangio + Chemo was acceptable but needed careful attention. These findings clarified the roles of ICIs and antiangiogenic agent-based treatment strategies in this population."

Journal • Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Perioperative Adebrelimab Plus Chemotherapy in Patients With Resectable Stage II-III NSCLC: 4-Year Update From a Phase 1b/3 Trial (IASLC-WCLC 2025) - P3 | "Patients received neoadjuvant treatment with 3 cycles of intravenous adebrelimab (20 mg/kg; day 1, Q3W), nab-paclitaxel (100 mg/m 2; days 1, 8, and 15, Q3W), and carboplatin (area under the curve 5 mg/mL per min; day 1, Q3W), followed by surgical resection and 16 additional cycles of adjuvant adebrelimab (20 mg/kg; day 1, Q3W). The safety profile remained consistent with previous reports, with no new safety signals identified. The randomized, double-blind, placebo-controlled phase 3 part of the trial is ongoing, with primary results expected soon."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR

Phase Ib/II Clinical Study of Adebrelimab Combined with Decitabine, Nab-Paclitaxel, and Gemcitabine as First-Line (IL) Treatment for Metastatic Pancreatic Cancer (mPC) (ESMO 2025) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Pancreatic Cancer • Solid Tumor

HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Ruijin Hospital

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=68 | Recruiting | Sponsor: Fudan University

New P1/2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Hebei Medical University Fourth Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Adebrelimab Plus Apatinib in Advanced Esophageal Squamous Cell Carcinoma Following Immune Checkpoint Inhibitors: Preliminary Results from Cohort 3 of CAP 02 Study (ESMO 2025) - No abstract available

Checkpoint inhibition • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A single-arm, prospective clinical study on the perioperative treatment of locally advanced squamous cell carcinoma of the head and neck with adebrelimab combined with apatinib mesylate (ChiCTR) - P4 | N=30 | Recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New P4 trial • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy and Safety of Cross-Line Adebrelimab Combined With Apatinib and Nab-Paclitaxel in Recurrent Small Cell Lung Cancer (IASLC-WCLC 2025) - "Introduction : Treatment options for relapsed small cell lung cancer (SCLC) remain limited, with second-line standard regimens (e.g., topotecan) demonstrating an objective response rate (ORR) of <25% and a median overall survival (OS) of 6-8 months. The CAPSTONE-1 study established adebrelimab combined with carboplatin and etoposide as the first-line standard of care for patients with extensive-stage SCLC in China...Patients received induction therapy comprising adebrelimab (1200 mg q3w), apatinib (250 mg qd), and nab-paclitaxel (200 mg/m2 q3w) for 2-4 cycles, followed by maintenance therapy with adebrelimab and apatinib until disease progression or intolerable toxicity. The primary endpoint was ORR, the secondary endpoints included PFS, OS, disease control rate (DCR),duration of response and safety assessed by CTCAE v5.0."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Adebrelimab as Consolidation Therapy in Limited-Stage Small Cell Lung Cancer After Hyperfractionatedradiotherapy Combined With Chemotherapy (IASLC-WCLC 2025) - "Patients will receive hyperfractionated radiotherapy at a dosage of 45 Gy (1.5 Gy bid, 5 days a week for 3 weeks) in combination with etoposide (100 mg/m 2 , iv, q3w) and platinum drugs (cisplatin 75 mg/m 2 or carboplatin AUC 5, iv, q3w) followed by maintenance with adebrelimab (1200 mg, iv, q3w) and etoposide/platinum drugs for up to 24 months. Based on an estimated improvement in 12-month PFS from 42% to 65% (one-sided α=0.05, 80% power) with a 24-month follow-up, a total of 36 evaluable patients are required assuming a 10% dropout rate. The trial is currently recruiting."

Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Adebrelimab Plus Irinotecan Liposome in ES-SCLC After First-Line Therapy: A Phase II Study (AIPATH) (IASLC-WCLC 2025) - P2 | "Methods : This multicenter, multicohort prospective phase II trial in China enrolls ES-SCLC patients aged 18-75 years with histologically or cytologically confirmed diagnoses, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, progression after first-line treatment with etoposide and platinum-based chemotherapy, at least one measurable, non-irradiated target lesion per RECIST version 1.1, a life expectancy ≥ 12 weeks, and adequate organ function. Primary endpoint is objective response rate.Secondary endpoints include overall survival (OS), 6-month OS rate, progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and safety. Exploratory endpoints include biomarker analysis, quality of life assessments, and long-term survivor characteristic.Trial registration: ChiCTR2400089170."

Clinical • IO biomarker • P2 data • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Pneumonia • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor