iparomlimab (QL1604) / Qilu Pharma - LARVOL DELTA

Iparomlimab and Tuvonralimab Injection in Combination With Lenvatinib or Axitinib for the Treatment of Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma That Has Failed First-Line Systemic Therapy (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Peking Union Medical College Hospital

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

Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer (clinicaltrials.gov) - P2 | N=29 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

ITHRAN: Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=123 | Recruiting | Sponsor: Wenjin Yin | Not yet recruiting ➔ Recruiting

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

Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Neoadjuvant short-course radiotherapy (SCRT) plus iparomlimab and tuvonralimab (QL1706), CAPOX, and regorafenib in locally advanced rectal cancer (LARC): A randomized, multicenter, non-comparative phase II trial in progress (ESMO 2025) - P2 | "In Group A, two cycles of induction treatment with QL1706 (5 mg/kg, D1), capecitabine (1000 mg/m 2 , bid, D1–14), oxaliplatin (130 mg/m 2 , D1), and regorafenib (80 mg, qd, D1–14) for a 21-day cycle will be given, followed by SCRT (5×5Gy), and four cycles of consolidation treatment the same as the induction treatment. Secondary endpoints include overall response rate, major pathologic response rate, tumor regression grade, R0 resection rate, organ preservation rate, two-year event-free survival rate, two-year disease-free survival rate, and five-year overall survival rate. Safety endpoints are adverse event, surgical complication, postoperative mortality, etc. Sample size is 44 in each group."

Clinical • Metastases • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Study on the Safety and Efficacy of Iparomlimab and Tuvonralimab Combined with Lenvatinib as Neoadjuvant Therapy for High-Risk Localized and Locally Advanced Renal Cell Carcinoma (ChiCTR) - P4 | N=19 | Not yet recruiting | Sponsor: Shandong Provincial Hospital; Shandong Provincial Hospital

New P4 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Real-world safety assessment of iparomlimab and tuvonralimab (QL1706) in advanced solid tumors: A multicenter observational study (ESMO 2025) - P4 | "However, the current findings are limited by the short follow-up duration. Further prospective studies with longer follow-up periods are warranted to evaluate the efficacy of QL1706 and its potential impact on survival outcomes in patients with solid tumors."

Clinical • Metastases • Observational data • Real-world • Real-world evidence • Hepatocellular Cancer • Oncology • Solid Tumor

THE SAFETY OF IPAROMLIMAB AND TUVONRALIMAB(QL1706) IN TREATMENT OF CERVICAL CANCER: A MULTICENTER PROSPECTIVE REAL-WORLD STUDY (IGCS 2025) - P=N/A | "As of March 31, 2025, a total of 32 CC patients (median age: 60 years; range: 32–84 years) were enrolled .Among the patients , the majority (66%) were diagnosed with Stage III or IV disease, all of whom had squamous cell carcinoma. The majority of patients had metastatic or recurrent CC, with 26 patients (81.25%) presenting one or more metastatic lesions. Most patients (29 [90.63%]) had ECOG performance status of 0~1."

Clinical • Real-world • Real-world evidence • Cervical Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CTLA4

Safety and efficacy of iparomlimab and tuvonralimab (QL1706) plus lenvatinib in previously untreated patients with clear cell renal cell carcinoma: Results from a phase Ib study (ESMO 2025) - P1/2 | "Background Immunotherapy-based combinations including pembrolizumab plus lenvatinib are standard first-line treatment for clear-cell renal cell carcinoma (ccRCC). Conclusions QL1706 plus lenvatinib showed well tolerability, manageable safety, and promising anti-tumor activity in first-line treatment for ccRCC, indicating its potential for this population. Further exploration of this combination is being planned."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CTLA4

Phase II, Single-Arm, Prospective, Single-Center Study of QL1706 Combined with Trastuzumab, Pertuzumab, and Albumin-Bound Paclitaxel as Neoadjuvant Therapy in HER2-Positive Breast Cancer Patients (ChiCTR) - P2 | N=76 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University; The Affiliated Hospital of Qingdao University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PD-L1 • PGR

Iparomlimab and Tuvonralimab combined with irinotecan liposome is used in recurrent/metastatic nasopharyngeal carcinoma after anti-PD - (L) 1 monoclonal antibody treatment (ChiCTR) - P2 | N=36 | Not yet recruiting | Sponsor: Chongqing University Cancer Hospital; Chongqing University Cancer Hospital

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A single-arm, single-center, phase II clinical study (ITBHaic Study) evaluating the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with Iparomlimab and Tuvonralimab(QL1706), and bevacizumab in initially potentially resectable hepatocellular carcinoma patients​ (ChiCTR) - P2 | N=34 | Not yet recruiting | Sponsor: Tianjin Cancer Hospital Airport Hospital; Tianjin Cancer Hospital Airport Hospital

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Iparomlimab and tuvonralimab (QL1706) vs cadonilimab for previously treated recurrent/metastatic cervical cancer (r/mCC): An unanchored matching-adjusted indirect comparison (MAIC) (ESMO 2025) - P1/2, P2 | "Adjustments for efficacy analysis included these variables plus prior bevacizumab use and radiotherapy...QL1706 could potentially serve as a new standard treatment option for this population. Legal entity responsible for the study Sun Yat-sen University Cancer Center."

Metastases • Cervical Cancer • Oncology • Solid Tumor

Prospective, Open-Label, Exploratory Clinical Study of TACE Combined with Iparomlimab and Tuvonralimab +/- TKI in the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Immune Checkpoint Inhibitors (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University

Checkpoint inhibition • New P4 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Single-Arm, Phase II Exploratory Study of Short-Course Radiotherapy (SCRT) Sequential to Iparomlimab and Tuvonralimab Combined with SOX Chemotherapy for Neoadjuvant Treatment of Gastric/Gastroesophageal Junction Adenocarcinom (ChiCTR) - P2 | N=38 | Not yet recruiting | Sponsor: Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute); Shandong First Medical University

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

A Single-Arm, Exploratory Study of Iparomlimab and Tuvonralimab Combined with GEMOX as First-Line Therapy for Unresectable or Metastatic Biliary Tract Malignancies (ChiCTR) - P4 | N=30 | Recruiting | Sponsor: The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University

New P4 trial • Biliary Cancer • Biliary Tract Cancer • Oncology

Exploratory Study of Systemic Therapy Containing Iparomlimab and Tuvonralimab Combined with TACE and/or HAIC in Conversion Therapy for Unresectable Intermediate to Advanced Hepatocellular Carcinoma (ChiCTR) - P3 | N=60 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University

New P3 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Iparomlimab and tuvonralimab (QL1706) plus bevacizumab and/or chemotherapy in first-line treatment for advanced hepatocellular carcinoma: Updated data from the phase II part of DUBHE-H-308 study (ESMO 2025) - P2/3 | "Methods Pts were randomized in a 1:1:1:1 ratio to receive QL1706 7.5 mg/kg plus bev 15 mg/kg and chemo of oxaliplatin 85 mg/m 2 plus capecitabine 1000 mg/m 2 (Group 1), QL1706 plus bev (Group 2), QL1706 plus chemo (Group 3), and sintilimab 200 mg plus bev (Group 4). Conclusions QL1706 plus bev and chemo showed encouraging efficacy and manageable safety profile in first-line treatment of HCC. QL1706 plus bev and chemo was selected as study group in the ongoing phase 3 study."

Clinical • Metastases • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor • CTLA4

A Single-Arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer (ChiCTR) - P2 | N=42 | Not yet recruiting | Sponsor: Qilu Hospital of Shandong University(Qingdao); Qilu Hospital of Shandong University(Qingdao)

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

An exploratory study on tuvonralimab/iparomlimab combined with chemotherapy for the treatment of advanced non-small cell lung cancer patients with EGFR uncommon mutations (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: Cancer Hospital, Chinese academy of Medical Sciences; Cancer Hospital, Chinese Academy of Medical Sciences

New trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and Safety of Iparomlimab/Tuvonralimab Combined with Chemotherapy in Patients with Non-small Cell Lung Cancer Leptomeningeal Metastasis: A Multicenter, Open-label, Single-arm Clinical Trial (ChiCTR) - P4 | N=33 | Not yet recruiting | Sponsor: The Affiliated Hospital of Fudan University, Hua Shan; The Affiliated Hospital of Fudan University, Hua Shan

New P4 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

A single-arm, single-center, open-label clinical trial of Iparomlimab and Tuvonralimab as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University

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

A single-arm, multicenter, exploratory clinical study on the third-line treatment of metastatic colorectal cancer with Iparomlimab and Tuvonralimab combined with anti-angiogenic drugs (ChiCTR) - P4 | N=44 | Not yet recruiting | Sponsor: Sichuan Provincial People's Hospital; Sichuan Provincial People's Hospital

New P4 trial • Colorectal Cancer • Oncology • Solid Tumor

A Single-Center, Single-Arm, Phase II Study of QL1706 (Iparomlimab and Tuvonralimab Injection) in Combination with Chemotherapy and Anti-angiogenic Therapy in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Failed Prior Platinum-Based Chemotherapy (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: The Second Affiliated Hospital Zhejiang University School of Medicine; The Second Affiliated Hospital Zhejiang University School of Medicine

New P2 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • MUC16