Ariely (adebrelimab) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Peking University Shenzhen Hospital

Biomarker • New P2 trial • Oncology

A phase 2, randomized, multicenter study of adjuvant adebrelimab plus capecitabine in resected cholangiocarcinoma with high-risk factors: ACHIEVE. (ASCO 2025) - P2 | "Key secondary endpoints include overall survival (OS) and RFS, minimal residual disease (MRD), and patient-reported tolerability, and safety. Enrollment has begun, with six sites in mainland China participating."

Clinical • P2 data • Biliary Cancer • Cholangiocarcinoma • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

NEO-ERA-01: A multi-center, single-arm, phase II study with neoadjuvant therapy of HAIC (GEMOX) combined with adebrelimab and lenvatinib for resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors. (ASCO 2025) - P2 | "Pts received 2-4 cycles of neoadjuvant therapy, consisting of HAIC-GEMOX (Oxaliplatin 85mg/m2 and Gemcitabine 800mg/m2 on Days 1 Q3W), Adebrelimab (1200mg on Days 3 Q3W) and Lenvatinib (8mg on Days 5-21 Q3W) , followed by curative-intent surgical resection. Neoadjuvant treatment with HAIC (GEMOX), Adebrelimab and Lenvatinib is feasible and safe prior to resection of ICC, without negatively affecting perioperative outcomes. Continued recruitment and follow-up are still ongoing. Clinical trail information: NCT06208462."

Clinical • P2 data • Biliary Cancer • Cardiovascular • Cholangiocarcinoma • Cough • Hematological Disorders • Hypertension • Oncology • Respiratory Diseases • Solid Tumor • Thrombocytopenia

Efficacy of adebrelimab with chidamide, gemcitabine, and S-1 in locally advanced or metastatic pancreatic cancer: A phase II study. (ASCO 2025) - P2 | "Chidamide enhanced the efficacy of immunotherapy and chemotherapy, improving outcomes compared to chemotherapy alone or in combination with immunotherapy. The ADEPT regimen showed promising antitumor activity and favorable tolerability as first-line therapy for locally advanced or metastatic pancreatic cancer. Further data from a large cohort and longer follow-up will be presented."

Clinical • Metastases • P2 data • Anemia • B Cell Lymphoma • Breast Cancer • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hepatology • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pancreatic Cancer • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • CA 19-9

Phase II clinical study of the efficacy and safety of adebrelimab in combination with lenvatinib as second-line treatment for advanced intrahepatic cholangiocarcinoma. (ASCO 2025) - P2 | "Adebrelimab combined with lenvatinib showed promising antitumor activity and manageable safety profile in patients with unresectable or metastatic ICC who had progressed on or were intolerant to first-line chemotherapy. These findings provide a rationale for further investigation of this regimen as a second-line treatment option."

Clinical • Combination therapy • Metastases • P2 data • Anemia • Biliary Cancer • Cholangiocarcinoma • Hepatitis B • Infectious Disease • Leukopenia • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • Thrombocytopenia

SHR-A1811 plus adebrelimab in unresectable or metastatic triple-negative breast cancer: Results from a phase 1b/2 expansion cohort. (ASCO 2025) - P2 | "We evaluated SHR-A1811 in combination with adebrelimab (anti-PD-L1 antibody), pyrotinib (irreversible, pan-HER receptor tyrosine kinase inhibitor), pertuzumab, or albumin-bound paclitaxel in unresectable or metastatic breast cancer in an open-label, dose-finding and efficacy expansion phase 1b/2 study. SHR-A1811 plus adebrelimab had a good safety and tolerability profile. The combination showed encouraging antitumor activity in unresectable or metastatic TNBC, irrespective of HER2 or PD-L1 expression status. Phase 2 preliminary efficacy summary.11HER2 and PD-L1 results were based on central lab assessment."

IO biomarker • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A phase II clinical study of adebrelimab and bevacizumab combined with cisplatin/carboplatin in triple-negative breast cancer patients with brain metastases. (ASCO 2025) - P2 | "The triplet treatment of anti-PD-L1 Adebrelimab, bevacizumab and cisplatin/carboplatin, was the first regimen demonstrating a high intracranial anti-tumor activity, a prolonged CNS-PFS and OS with a good safety profile. Warranting further investigation in this highly aggressive disease. Clinical trial information: NCT04303988."

Clinical • P2 data • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

SHR-8068 plus adebrelimab and bevacizumab for advanced hepatocellular carcinoma (aHCC): A phase 1b/2 study. (ASCO 2025) - P1/2, P3 | "SHR-8068 combined with adebrelimab and bevacizumab showed promising efficacy and manageable safety in aHCC. A more favorable benefit-risk profile was observed for SHR-8068 given as a priming dose. A phase 3 trial (NCT06618664) is currently underway to further assess the combination as 1L treatment for aHCC."

Metastases • P1/2 data • Cardiovascular • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor

A prospective, single-arm, phase II study of adebrelimab plus carboplatin and albumin-bound taxanol as neoadjuvant therapy in patients with resectable locally advanced head and neck squamous cell carcinoma. (ASCO 2025) - P2 | "As a course of treatment every three weeks, albumin-bound paclitaxel 260 mg/m2, carboplatin AUC=5 and Adebrelimab 1200 mg were given intravenously on the first day of every three weeks. In terms of head and neck squamous cell carcinoma, Phase I clinical studies have confirmed the therapeutic safety and tumor activity of PD-L1 inhibitors. In this Phase II study, the PD-L1 inhibitor (Adebrelimab) demonstrated a favorable therapeutic response to locally advanced head and neck squamous cell carcinoma, and we look forward to final therapeutic data."

Clinical • Metastases • P2 data • Alopecia • Dermatology • Head and Neck Cancer • Immunology • Oncology • Pruritus • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A prospective, single-arm, phase II trial of adebrelimab plus nab-paclitaxel and carboplatin in patients with unresectable advanced metastatic or recurrent thymic carcinomas. (ASCO 2025) - P2 | "In previously untreated advanced TCs, preliminary results showed that adebrelimab plus nab-paclitaxel and carboplatin is effective and safe. It provides a new treatment option in pts with advanced TCs."

Clinical • Metastases • P2 data • Immunology • Myositis • Oncology • Solid Tumor • Thymic Carcinoma • Thymus Cancer

Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Jiangsu Cancer Institute & Hospital

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

Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC (clinicaltrials.gov) - P2 | N=164 | Not yet recruiting | Sponsor: Zhigang Li | Initiation date: Mar 2025 ➔ Jul 2025

Trial initiation date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=762 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Adebrelimab Combined with Short-Course Radiotherapy and CAPOX as Total Neoadjuvant Therapy for pMMR Locally Advanced Rectal Cancer: Interim Results (ESMO-GI 2025) - No abstract available

Clinical • Metastases • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Adebrelimab plus apatinib for maintenance treatment of extensive-stage small cell lung cancer after first-line induction with adebrelimab plus chemotherapy (CLOG2402-ADAPT): a multi-center, single-arm, phase 2 clinical trial (ELCC 2025) - P=N/A, P2 | "The phase III ETER701 clinical trial demonstrated the survival benefits of adding anlotinib to benmelstobart and chemotherapy, but the risks of hemoptysis and occult blood test positive cannot be ignored. The primary endpoint is progression-free survival (PFS). The secondary endpoints include objective response rate, disease control rate, PFS2, duration of response, overall survival, and safety."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC (clinicaltrials.gov) - P1/2 | N=400 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Shanghai Zhongshan Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Sep 2025

Enrollment closed • Trial completion date • Biliary Cancer • Cholangiocarcinoma • Hepatology • Oncology • Solid Tumor • CTLA4

SHR-A1811-Ib/II-205: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=258 ➔ 76 | Trial primary completion date: Jul 2026 ➔ Apr 2025 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

ACADEMY: A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Neoadjuvant SNF Precision Therapy Phase III (clinicaltrials.gov) - P3 | N=404 | Not yet recruiting | Sponsor: Fudan University

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: China Medical University, China

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

Phase II clinical study of adebrelimab plus apatinib and SOX regimen for conversion therapy of advanced gastric or gastroesophageal junction adenocarcinoma (ChiCTR) - P2 | N=49 | Recruiting | Sponsor: Beijing Friendship Hospital, Capital Medical University; Beijing Friendship Hospital, Capital Medical University

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