iparomlimab (QL1604) / Qilu Pharma - LARVOL DELTA

A Phase 2 Trial of QLC5508 (MHB088C) Plus QL1706 or QL2107 as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (IASLC-WCLC 2026) - "This study aimed to evaluate the efficacy and safety of QLC5508 in combination with QL1706 (iparomlimab and tuvonralimab, a bifunctional antibody targeting PD-1 and CTLA-4) or QL2107 (a pembrolizumab biosimilar) as first-line treatment in patients with ES-SCLC. Conclusions : QLC5508 in combination with QL1706 or QL2107 as first-line treatment showed promising anti-tumor activity and a manageable safety profile in patients with ES-SCLC. The combined regimen of B7H3 ADC plus PD-1 or PD-1/CTLA-4 antibody is a potential therapy for ES-SCLC and worthy of further exploration."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

CCGLC-017: Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: Tongji Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor • PD-L1

Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombosis

Case Report: Iparomlimab and Tuvonralimab-based therapy for epithelioid malignant peritoneal mesothelioma: a three-case series. (PubMed, Front Oncol) - "QL1706 plus bevacizumab subsequently produced stable disease with symptomatic improvement for approximately 7 months...QL1706 plus dose-reduced lenvatinib achieved a partial response that remained ongoing for more than 10 months...QL1706-based therapy achieved disease control in all three patients with EMPM who had limited conventional treatment options, including a durable response in an elderly patient with PD-L1-negative disease and rapid tumor regression with QL1706 monotherapy. The contrasting clinical courses suggest that overall benefit depends not only on tumor sensitivity but also on the accompanying treatment strategy and baseline organ function."

Journal • Glomerulonephritis • Mesothelioma • Nephrology • Oncology • Peritoneal Mesothelioma • Renal Disease • Solid Tumor • PD-L1

A Single-Arm Study of QL1706 Combined With DOS as Neoadjuvant Therapy for Locally Advanced Gastric/GEJ Adenocarcinoma (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University

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

Low-dose interleukin-2 combined with thalidomide for a severe cutaneous immune-related adverse event associated with PD-1/CTLA-4 bispecific antibody therapy: a case report. (PubMed, Immunotherapy) - "We report the case of a patient with gastric cancer who developed rapidly progressive erythema and pruritus after treatment with iparomlimab and tuvonralimab. Because Ld-IL2, thalidomide, and corticosteroids were administered concurrently, the independent contribution of each treatment and the underlying immunological mechanism could not be determined. However, further studies are warranted to clarify the potential value of this combined regimen in the management of such adverse events."

Adverse events • Journal • Dermatology • Gastric Cancer • Oncology • Pruritus • Solid Tumor • CTLA4

Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombosis

Iparomlimab and tuvonralimab in previously treated patients with cervical cancer. (PubMed, Cell Rep Med) - P2 | "This multi-center single-arm phase 2 trial recruits patients with recurrent or metastatic cervical cancer (r/m CC) who have failed at least first-line platinum-based chemotherapy with or without bevacizumab. QL1706 shows promising efficacy and is well tolerated in previously treated patients with r/m CC. The trial is registered at clinicaltrials.gov (NCT05557565)."

Journal • Cervical Cancer • Oncology • Solid Tumor

A Prospective, Single-Arm, Single-Center Phase II Clinical Trial of Iparomlimab/Tuvonralimab as Neoadjuvant Immunotherapy for Locally Advanced Gastric Adenocarcinoma with Microsatellite Instability-High/Deficient Mismatch Repair (MSI-H/dMMR) (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Beijing Cancer Hospital; Beijing Cancer Hospital

dMMR • Mismatch repair • MSI-H • New P2 trial • Gastric Adenocarcinoma • Gastric Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

A single-arm, exploratory study of Iparomlimab and Tuvonralimab (QL1706) combined with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable or metastatic intrahepatic cholangiocarcinoma (ChiCTR) - P4 | N=32 | Recruiting | Sponsor: Qilu Hospital of Shandong University; Qilu Hospital of Shandong University

New P4 trial • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Neoadjuvant treatment of QL1706 in patients with resectable microsatellite instability-high/mismatch repair-deficient colon cancer: Results from a phase 1b trial. (ASCO 2026) - P3 | "This study aimed to evaluate the efficacy and safety of iparomlimab and tuvonralimab (QL1706), a bifunctional antibody targeting both PD-1 and CTLA-4, as neoadjuvant treatment in patients with microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) colon cancer. Neoadjuvant treatment of QL1706 showed promising pCR rate and manageable safety in patients with MSI-H/dMMR colon cancer. A phase 3 trial is ongoing to further confirm the efficacy and safety of QL1706 as neoadjuvant treatment in patients with resectable MSI-H/dMMR colon cancer."

Clinical • dMMR • Mismatch repair • MSI-H • P1 data • Acute Kidney Injury • Colon Cancer • Colorectal Cancer • Genetic Disorders • Immunology • Microsatellite Instability • Nephrology • Oncology • Renal Disease • Solid Tumor • MSI

A double-blind, double-dummy, randomized, controlled phase 3 trial of iparomlimab and tuvonralimab (QL1706) vs QL1604 as consolidation therapy following concurrent or sequential chemoradiotherapy (cCRT/sCRT) in patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). (ASCO 2026) - P3 | "An interim analysis is planned. The study will be conducted across around 79 sites in China, and enrollment is ongoing."

Clinical • IO biomarker • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

The exploration of iparomlimab and tuvonralimab combined with de-escalated chemotherapy as an innovative neoadjuvant treatment strategy for locally advanced cervical cancer: a case report from the NICE-CC trial. (PubMed, Front Immunol) - "In conclusion, this case highlights the potential of one cycle of neoadjuvant dual immunotherapy combined with standard chemotherapy, followed by two additional cycles of dual immunotherapy, for the treatment of LACC. This innovative treatment regimen warrants further investigation in the ongoing NICE-CC trial."

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

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - P2 | N=39 | Recruiting | Sponsor: Peking Union Medical College | Trial primary completion date: Jul 2026 ➔ Jul 2028

Trial primary completion date • Oncology • Salivary Gland Cancer • HER-2 • NTRK

SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Second Affiliated Hospital of Nanchang University | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Oncology • Solid Tumor • PD-L1

A randomized, open-label, multicenter clinical study comparing the combination of epalorlimovalizumab and bevacizumab with TAS-102 versus bevacizumab combined with TAS-102 in the second-line treatment of advanced colorectal cancer (ChiCTR) - P4 | N=84 | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital | Initiation date: Aug 2025 ➔ Apr 2026

Trial initiation date • Colorectal Cancer • Oncology • Solid Tumor • APOC1 • APOE • CXCL10 • CXCL9 • GBP1 • GBP4 • GBP5 • MX1 • PSMB9 • RSAD2 • SDC2 • SPP1 • STAT1 • TAP1

Single-Arm, Phase II Clinical Study of Ipalolimab and Tovorelimab in Combination with Regorafenib and Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (G/GEJ) Adenocarcinoma (ChiCTR) - P2 | N=35 | Sponsor: Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi

New P2 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • PD-L1

Iparomlimab Plus Tovorilimab Combined With Bevacizumab and Chemotherapy as First-Line Treatment for Advanced Mesothelioma (clinicaltrials.gov) - P2 | N=37 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Mesothelioma • Oncology • Solid Tumor

A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

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

Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=26 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Huazhong University of Science and Technology

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

A Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P4 | N=55 | Not yet recruiting | Sponsor: Huazhong University of Science and Technology

Heterogeneity • New P4 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

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

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