Qibeian (iparomlimab/tuvonralimab) / Sound Biologics, Qilu Pharma - LARVOL DELTA

Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCC (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Changhai Hospital

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

Neoadjuvant therapy of iparomlimab and tuvonralimab combined with chemotherapy-eclipse for locally advanced cervical cancer (NICE-CC): an investigator-initiated, multicentre, open-label, phase II trial (SGO 2026) - No abstract available

Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

QLS5132 Combination Therapy in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=626 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Endometrial Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerability, and Efficacy. (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Tao Zhang

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

Iparomlimab/Tuvonralimab + Standard Chemotherapy and Olaparib in Platinum-Sensitive Recurrent Ovarian Cancer (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University

New P2 trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • BRCA

SHR-A1811 plus QL1706 versus standard therapy as first-line treatment for locally advanced or metastatic HER2-overexpressing non-small cell lung cancer: an open-label, single-arm, phase II clinical trial (ChiCTR) - P2 | N=39 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CTCs • EGFR • HER-2 • ROS1

An Exploratory Study of QL1706 Plus Chemotherapy in Perioperative NSCLC (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Peking Union Medical College Hospital

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Jiangsu Cancer Institute & Hospital

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

SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Fujian Cancer Hospital | Trial completion date: Dec 2027 ➔ Dec 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2026 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Tumor mutational burden • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Neoadjuvant therapy of iparomlimab and tuvonralimab combined with chemotherapy-extenuated for locally advanced cervical cancer (NICE-CC): an investigator-initiated, multicentre, open-label, phase II trial. (PubMed, J Gynecol Oncol) - P2 | "A total of 43 patients diagnosed with International Federation of Gynecology and Obstetrics 2018 stage IB3, IIA2, IIB, or IIIC1r will receive iparomlimab and tuvonralimab (5 mg/kg, intravenously), nab-paclitaxel (60 mg/m², intravenously), and cisplatin (75-80 mg/m², intravenously) for the first cycle. Additionally, the exploratory endpoint will focus on identifying predictive biomarkers associated with tumor response. ClinicalTrials.gov Identifier: NCT07055399."

IO biomarker • Journal • P2 data • Cervical Cancer • Cervical Squamous Cell Carcinoma • Gynecology • Obstetrics • Oncology • Solid Tumor • Squamous Cell Carcinoma • CTLA4

QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Affiliated Hospital of Nantong University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2

Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=82 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Sun Yat-sen University

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

Phase II Clinical Trial of QL1706 in Combination with Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (ChiCTR) - P2 | N=31 | Not yet recruiting | Sponsor: The affiliated hospital of Qingdao university; The affiliated hospital of Qingdao university

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

NEO-ITHRAN: Neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer (clinicaltrials.gov) - P2 | N=55 | Not yet recruiting | Sponsor: RenJi Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A prospective, single-arm, single-center Phase II clinical study to evaluate the efficacy and safety of iparomlimab (QL1706) combined with paclitaxel (albumin-bound) induction + paclitaxel (albumin-bound) concurrent chemoradiotherapy + iparomlimab (QL1706) maintenance as first-line treatment for unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ChiCTR) - P2 | N=37 | Not yet recruiting | Sponsor: Chinese People's Liberation Army (PLA) General Hospital; Chinese People's Liberation Army (PLA) General Hospital

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

First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunotherapy Combined With Chemotherapy (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Iparomlimab and tuvonralimab (QL1706) with bevacizumab and/or chemotherapy in first-line (1L) treatment of advanced hepatocellular carcinoma (aHCC): A randomized, open-label, phase II/III study (DUBHE-H-308) (ESMO 2024) - P2/3 | "Thus the Phase 2 part of DUBHE-H-308 study (NCT05976568) investigating QL1706 with bev and/or chemotherapy (chemo) for 1L treatment of aHCC was conducted and the results were reported here. Patients (pts) were randomly assigned (1:1:1:1) to the arm 1 QL1706 (7.5 mg/kg, Q3W) + bev (15 mg/kg, Q3W)+chemo (aHCC regimen, namely oxaliplatin 85 mg/m2 plus capecitabine 1000 mg/m2, Q3W, up to 4 cycles), the arm 2 QL1706 + bev, the arm 3 QL1706 + chemo, or the arm 4 another PD-1 antibody sintilimab (200 mg, Q3W)+ bev. In the Phase 2 part of DUBHE-H-308 study, QL1706 plus bev with chemo showed encouraging preliminary efficacy and a manageable safety profile in 1L treatment of aHCC. QL1706 + bev + XELOX was selected as study arm by Independent Data Monitoring Committee for future Phase 3 study."

Clinical • Late-breaking abstract • Metastases • P2/3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Exploratory Study of Transarterial Chemoembolization (TACE) Combined with Eparlitozoviril Antibody and Lenvatinib for Intermediate-to-Advanced Hepatocellular Carcinoma (ChiCTR) - P=N/A | N=30 | Recruiting | Sponsor: The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Jiangsu Cancer Institute & Hospital

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2

Phase 2 Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Single-Arm Trial of QL1706, Lenvatinib, and Nab-Paclitaxel for Advanced Refractory Penile Cancer (clinicaltrials.gov) - P2 | N=47 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor

QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

A Single-Arm, Phase II Clinical Study of QL1706 in Combination with Lenvatinib for the Neoadjuvant Treatment of Resectable Extremity and Mucosal Melanoma (ChiCTR) - P2 | N=20 | Recruiting | Sponsor: Fujian Provincial Tumor Hospital; Fujian Provincial Tumor Hospital

New P2 trial • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • PD-L1