Tabosun (ipilimumab N01 injection) / Innovent Biologics, Fortvita Biologics - LARVOL DELTA

Organ-preservation value of sequential PD-1 inhibitors followed by selective sintilimab/IBI310/lenvatinib in non-metastatic MSI-H/dMMR gastric and colon cancer. (ESMO 2026) - No abstract available

dMMR • Metastases • MSI-H • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Effectiveness and safety of IBI310 combined with sintilimab versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma (aHCC): A randomized, open-label, controlled, multicenter phase III clinical study. (ASCO 2026) - P3 | "Compared with sorafenib group, combination treatment of IBI310 + sintilimab as first-line treatment demonstrated survival benefits and a manageable safety profile in aHCC. Survival data."

Clinical • Metastases • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Surufatinib combined with sintilimab and IBI310 for the treatment of high-grade advanced-neuroendocrine neoplasms: A single arm, open-label, single-center, phase II study. (PubMed, Int J Cancer) - P2 | "Serious adverse events occurred in 45.2% of patients. These findings suggest that surufatinib, IBI310, and sintilimab may offer clinical benefit with manageable toxicity in patients with advanced HG-NENs."

Journal • P2 data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

A Clinical Study to Evaluate the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) Combined with IBI310 and Sintilimab as Neoadjuvant Therapy for Hepatocellular Carcinoma Prior to Hepatectomy (ChiCTR) - P=N/A | N=43 | Not yet recruiting | Sponsor: The Third Affiliated Hospital of Naval Medical University; The Third Affiliated Hospital of Naval Medical University

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

Bringing immunotherapy to clinical practice in dMMR/MSI-high colon cancer. (PubMed, Cancer Cell) - "showed that dual anti-CTLA-4/PD-1 IBI310/sintilimab for 6 weeks improved pathological complete response over sintilimab in patients with cT4/N+ tumors. This combination represents a referral regimen for neoadjuvant or organ-preserving strategies."

dMMR • Journal • MSI-H • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. (ASCO 2024) - P3 | "Neoadjuvant IBI310 plus sintilimab significantly improved pCR rate than sintilimab alone in MSI-H/dMMR CRC. The safety profiles were comparable and manageable in both treatment arms."

Clinical • Mismatch repair • P1 data • Cardiovascular • Colorectal Cancer • Endocrine Disorders • Gastrointestinal Cancer • Gastrointestinal Disorder • Microsatellite Instability • Oncology • Solid Tumor • MSI

Neoadjuvant Immunotherapy in Localized dMMR/MSI-H Colon Cancer: A Systematic Review of Pathological Response and Surgical Outcomes. (PubMed, Ann Surg Oncol) - "Neoadjuvant immune checkpoint inhibition demonstrates substantial pathological activity and apparent surgical feasibility in selected localized dMMR/MSI-H colon cancer. Longer follow-up and comparative trials are needed to define regimen, timing, patient selection, and durable oncological benefit."

dMMR • Journal • MSI-H • Review • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CTLA4 • MSI

Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2/3 | N=720 | Recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Xijing Hospital

New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor • MSI

A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC (clinicaltrials.gov) - P3 | N=344 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed

Trial completion • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2/3 | N=720 | Not yet recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

New P2/3 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

NeoShot: A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer (clinicaltrials.gov) - P3 | N=453 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

dMMR • Enrollment closed • Mismatch repair • MSI-H • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

TACE or Ablation Combined with Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma with Intermediate-High Recurrence Risk (ChiCTR) - P2 | N=90 | Sponsor: The First Afliated Hospital of Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-sen University

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment. (clinicaltrials.gov) - P2/3 | N=680 | Recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

Initial efficacy of surufatinib plus sintilimab and IBI310 for patients with high-grade advanced-neuroendocrine neoplasm: A multicenter, single arm phase 2 study (AACR 2024) - "Ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) has been recommended for extrapulmonary and non-pancreatic NEC if the disease progresses following chemotherapy by the NCCN guidelines for neuroendocrine tumors. Surufatinib combined with Sintilimab and IBI310 showed a potential antitumor activity and a tolerable safety profile, providing an additional treatment option for pts with high-grade NEN."

Clinical • Metastases • P2 data • Endocrine Cancer • Neuroendocrine Neoplasm • Neuroendocrine Tumor • Oncology • Solid Tumor • FGFR1

ACTION-I: TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment. (clinicaltrials.gov) - P2/3 | N=680 | Not yet recruiting | Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

New P2/3 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC (clinicaltrials.gov) - P3 | N=344 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Trial completion • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Innovent Biologics, Inc…announces that the New Drug Application (NDA) for TABOSUN (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by China's National Medical Products Administration (NMPA (The Manila Times) - "Approval is based on results from the randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742), which evaluated the safety and efficacy of ipilimumab N01 combined with sintilimab as neoadjuvant therapy compared with direct radical surgery for MSI-H/dMMR colon cancer."

China approval • dMMR • MSI-H • Colon Cancer

Neoadjuvant IBI310 plus sintilimab in locally advanced MSI-H/dMMR colon cancer: Interim results of the phase III neoshot study (ESMO-IO 2025) - P3 | "In experimental arm, TEAEs led to surgery delay in 6.6% pts (median 15.5 days [range: 3.5-26.5]) and no TEAE led to surgery cancellation.Conclusions Neoadjuvant IBI310 + sintilimab showed encouraging pCR rate in locally advanced colon cancer. The study is currently ongoing, with continued patient recruitment and EFS follow-up."

Clinical • dMMR • Metastases • MSI-H • P3 data • P3 data: top line • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Neoadjuvant treatment of IBI310 plus sintilimab in locally advanced MSI-H/dMMR colon cancer: A randomized phase 1b study. (PubMed, Cancer Cell) - P3 | "One death occurred in each arm due to postoperative complication and adverse events. These findings demonstrate the added benefit of neoadjuvant IBI310 plus sintilimab over sintilimab monotherapy for locally advanced MSI-H/dMMR colon cancer."

dMMR • Journal • MSI-H • P1 data • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CTLA4 • MSI

Updated results from a multicenter, single-arm phase II study of surufatinib plus sintilimab and IBI310 in patients with high-grade advanced-neuroendocrine neoplasm (HG-NEN). (ASCO 2025) - P2 | "Ipilimumab (anti-CTLA-4 antibody) plus nivolumab (anti-PD-1 antibody) is recommended by the NCCN guidelines for extrapulmonary and non-pancreatic neuroendocrine carcinomas (NEC) that progress after chemotherapy. Surufatinib combined with sintilimab and IBI310 demonstrated promising efficacy and manageable safety in HG-NEN, with greater benefit observed in earlier treatment lines. This regimen may offer a new therapeutic option for patients with HG-NEN."

Clinical • Metastases • P2 data • Cardiovascular • Endocrine Cancer • Hematological Disorders • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Pancreatitis • Solid Tumor • Thrombocytopenia • CSF1R • FGFR1

A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers (clinicaltrials.gov) - P1 | N=148 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion

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

Sintilimab Combined with IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Peking University | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • PD-L1