Qibeian (iparomlimab/tuvonralimab) / Sound Biologics, 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

Iparomlimab and tuvonralimab (QL1706) vs zimberelimab for previously treated recurrent/metastatic cervical cancer (r/mCC): An unanchored matching-adjusted indirect comparison (MAIC) (ESMO Asia 2025) - P2 | "For efficacy and safety analysis, adjustments were made for age, histologic type, Eastern Cooperative Oncology Group (ECOG) performance status (PS), combined positive score (CPS), prior treatment lines, prior bevacizumab use and prior radiotherapy. After matching, QL1706 had effective sample sizes (ESS) of 90 for efficacy and 90.2 for safety analyses. These findings indicate that QL1706 demonstrated favourable efficacy and a comparable safety profile compared to zimberelimab for previously treated r/mCC patients. QL1706 could potentially serve as a new standard treatment option for this population."

Metastases • Cervical Cancer • Oncology • Solid Tumor • PD-L1

The safety and efficacy of iparomlimab and tuvonralimab (QL1706) in treatment of cervical cancer: A multicenter prospective real-world study (ESMO Asia 2025) - P=N/A | "These preliminary findings indicate that QL1706 demonstrates a manageable safety profile and promising efficacy in the treatment of cervical cancer."

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

A Phase 2 Randomized, Controlled Trial of QL1706 Plus Chemotherapy and Quad Shot for Driver Gene-negative Advanced Non-small Cell Lung Cancer. (clinicaltrials.gov) - P2 | N=104 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=290 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • 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

TITAN-HCC: Neoadjuvant and Adjuvant QL1706 With TACE in Resectable Hepatocellular Carcinoma Beyond Milan Criteria (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Fudan University

IO biomarker • New trial • Hepatocellular 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

Safety of long-term treatment of iparomlimab and tuvonralimab (QL1706) in phase I trial (ESMO-IO 2025) - P1, P1b | "The most common QL1706-related adverse events of ≥grade 3 with incidence of >1.0% were anemia (1.7%), lipase increased (1.5%), alanine aminotransferase (1.2%), aspartate aminotransferase, platelet count decreased (1.2%), and immune-mediated lung disease (1.2%).Conclusions Long-term treatment of QL1706 showed favorable safety profile, especially in severe toxicity, and no new safety signal was observed. The safety profile did not show obvious increase in pts receiving QL1706 for ≥12 months compared to those receiving QL1706 for <12 months.Clinical trial identification NCT04296994 and NCT05171790.Legal entity responsible for the study The authors."

Clinical • P1 data • Oncology • Solid Tumor • PD-1

QLC5508-201: A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=444 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor

QLMA-IIT-CC-001: Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or Locally Advanced HER2+ Breast Cancer (clinicaltrials.gov) - P2 | N=188 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=89 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Xijing Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DUBHE-L-303: A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=606 | Active, not recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Sun Yat-sen University | Initiation date: Jun 2025 ➔ Sep 2025

Trial initiation date • Oncology • Sarcoma • Soft Tissue Sarcoma • 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

A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment (clinicaltrials.gov) - P2 | N=18 | Not yet recruiting | Sponsor: Harbin Medical University

New P2 trial • pMMR • Colorectal Cancer • Oncology • Solid Tumor

A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Chemotherapy (FOLFOXIRI) as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Yanqiao Zhang

New P2 trial • pMMR • Colorectal Cancer • Oncology • Solid Tumor • BRAF

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

Efficacy and Safety of QL1706 combined with Regorafenib or Fruquintinib as Third-Line Therapy for Advanced Colorectal Cancer (ChiCTR) - P4 | N=26 | Not yet recruiting | Sponsor: Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital

New P4 trial • Colorectal Cancer • Oncology • 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

INNOVATE: Efficacy and Safety of Anti-PD-1/CTLA-4Bispecific Antibody (QL1706) Combined with Paclitaxel-Carboplatin as Neoadjuvant Therapy in Advanced High-Grade Serous Ovarian Cancer:A Prospective,Multicenter, Single-Arm Phase II Trial (ChiCTR) - P2 | N=45 | Not yet recruiting | Sponsor: First Affiliated Hospital of Bengbu Medical University; First Affiliated Hospital of Bengbu Medical University

New P2 trial • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • 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