Cipterbin (inetetamab) / 3SBio - LARVOL DELTA

Neoadjuvant Inetetamab and Pyrotinib and Nab-paclitaxel for HER2+Breast Cancer (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Xijing Hospital | Not yet recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

An Open-label, Two-Cohort, Phase II Study Evaluating Efficacy and Safety of NLX + NVB-Based Regimens in HER2-Positive MBC (ChiCTR) - P4 | N=321 | Not yet recruiting | Sponsor: Shanghai GoBroad Cancer Hospital; Shanghai GoBroad Cancer Hospital

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Inetetamab Combined with Pyrotinib for HER2-Positive Advanced Breast Cancer: A Multicenter Real-World Retrospective Study (ESMO 2026) - No abstract available

Metastases • Real-world • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world outcomes and safety of inetetamab plus pyrotinib and chemotherapy in HER2-positive metastatic breast cancer: A multicenter retrospective study. (PubMed, Ther Adv Med Oncol) - "In first-line setting, baseline lymphovascular invasion (LVI) and multiple metastases were independent prognostic factors, and trastuzumab-naïve patients had a numerically longer median PFS of 27.0 months than those with prior trastuzumab exposure. The IPyC regimen was associated with manageable toxicity, with grade 3-4 diarrhea (26.2%), neutropenia (16.6%), and leukopenia (12.6%) as the most common adverse events (AEs). As a retrospective descriptive study, our analysis describes the use and outcomes of the IPyC regimen across multiple lines of therapy in HER2-positive MBC, highlighting the need for and supporting the design of prospective studies to evaluate this regimen."

Journal • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Dual HER2-targeted therapy with pyrotinib plus inetetamab and adebrelimab in previously treated HER2-amplified metastatic colorectal cancer: A prospective, single-arm, phase II clinical trial. (ASCO 2026) - P=N/A | "The novel triple combination of adebrelimab, pyrotinib, and inetetamab represents a viable and active strategy for HER2-amplified mCRC after prior therapy. The observed efficacy in patients refractory to prior HER2-targeted therapies, including ADCs, warrants further investigation of this regimen in this population with limited options."

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

Neoadjuvant toripalimab combined with inetetamab, pertuzumab, and nab‑paclitaxel in HER2‑positive breast cancer (TORCH): A phase II trial. (ASCO 2026) - P4 | "The combination of toripalimab, dual anti‑HER2 blockade (inetetamab/pertuzumab), and nab‑paclitaxel showed promising efficacy and manageable toxicity in the neoadjuvant setting for HER2‑positive BC. These findings support further evaluation in randomized trials."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and safety results of a prospective phase II study (IPUtrial) of inetetamab and pyrotinib in combination with utidelone for first- or second-line treatment of HER2-positive metastatic breast cancer. (ASCO 2026) - "Patients who have previously used trastuzumab must meet the followings: for first-line treatment, neoadjuvant therapy was effective, and relapse occurred over 1 year after the end of adjuvant therapy; for second-line treatment, progressed in previous adjuvant/neoadjuvant therapy or progressed within 1 year of completion of trastuzumab therapy; disease progression occurred after 6 months of treatment with trastuzumab in advanced setting. The regimen demonstrated clinically meaningful activity of this triplet regimen for the first/second-line treatment of HER2-positive MBC, evidenced by high ORR (82.4%), durable median PFS (13.1 months), with encouraging 35-month OS rate (78.5%). Predominant toxicities (diarrhea, neuropathy) were controllable through supportive measures and dose adjustments. These data support phase III evaluation of this combination strategy."

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Inetetamab plus camrelizumab and utidelone for pretreated HER2-positive advanced breast cancer: a prospective, single-arm, phase 2 study. (PubMed, BMC Med) - P2 | "The combination of inetetamab, camrelizumab, and utidelone demonstrated promising efficacy and a manageable safety profile in heavily pretreated patients with HER2-positive MBC. These findings support this regimen as a viable treatment option in this setting and warrant further investigation in randomized controlled trials."

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • HER-2

First-line Inetetamab Plus PD-1 And Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma: A Prospective, Single-arm, Phase II study (ChiCTR) - P2 | N=32 | Not yet recruiting | Sponsor: HenanCancerHospital; HenanCancerHospital

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

BRIGHT: RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure (clinicaltrials.gov) - P2/3 | N=268 | Not yet recruiting | Sponsor: Fudan University

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-World Outcomes With Inetetamab-Based Regimens for HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Analysis in China. (PubMed, Cancer Control) - "Patients previously treated with trastuzumab without HER2-TKIs had longer median PFS than those with prior TKI exposure (12.8 vs 5.7 months; P = 0.001). No treatment-related deaths were reported.ConclusionInetetamab-based regimens have shown promising efficacy and are well-tolerated for patients with HER2-positive MBC. These anti-HER2 regimens could be considered an alternative treatment option for this disease."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Inetetamab-Based Regimens for Patients with HER2-Positive Metastatic Breast Cancer: A Real-World Retrospective Study. (PubMed, Breast Cancer (Dove Med Press)) - "The most frequently combined chemotherapy was vinorelbine (83/90,92.2%). The most frequently concomitant targeted drug was pyrotinib (70/90,77.8%)...Inetetamab offers a promising option and a manageable safety profile for HER2-positive MBC who pretreated with multiple-line therapies. Meanwhile, inetetamab plus small-molecule TKIs regimens shows good anti-tumor efficacy for MBC with brain metastases, which deserves further validation in a larger group trial."

Journal • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Early use of CDK4/6 inhibitor combined with endocrine therapy plus anti-HER2 antibody may get more survival benefit in HR+/HER2+ advanced breast cancer: result from a phase II single-arm mini cohort study (CABC016) (SABCS 2025) - P2 | "Patients are treated with palbociclib at a dose of 125 mg daily on days 1 - 21 of a 28 - day cycle, plus trastuzumab (H, trastuzumab or inetetamab) or trastuzumab plus pertuzumab (HP) intravenously on day 1 of each 21-day cycle. ET options included aromatase inhibitor (AI), tamoxifen or fulvestrant depend on endocrine sensitivety, with ovarian suppression required for premenopausal patients... This mini cohort study showed palbociclib plus ET plus anti-HER2 antibody could be one of the optimal initial treatment options for metastatic setting of HR+/HER2+ breast cancer, especially for early use during ET-based regimen, even for stable brain disease."

Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Case Report: Effectiveness of Inetetamab combined with immunochemotherapy as first-line treatment in two cases of advanced gastric cancer with HER2 expression: a retrospective analysis. (PubMed, Front Oncol) - "They were treated with a combination of Inetetamab, Tislelizumab, and the XELOX regimen (Inetetamab 300mg administered on Day 1; Tislelizumab 200mg administered on Day 1; Oxaliplatin 150mg administered on Day 2; Capecitabine 1.5g orally twice daily on Days 1-14; repeated every 3 weeks per cycle). The findings of this study suggest a novel first-line treatment strategy for advanced gastric cancer, potentially improving treatment efficacy and quality of life for HER2-positive gastric cancer patients. Nevertheless, further clinical trials are warranted to validate the efficacy and safety of this treatment approach."

Journal • Retrospective data • Gastric Cancer • Oncology • Solid Tumor • HER-2

Combined treatment of inetetamab plus pyrotinib and vinorelbine in managing advanced HER2-positive breast cancer patients (ILLUMINE): a multicenter, retrospective, real-world study. (PubMed, Transl Breast Cancer Res) - "No severe TAAEs were observed during the investigation. The triple regimen of inetetamab plus pyrotinib and vinorelbine exhibited promising therapeutic effects and was tolerable for participants with HER2-positive ABC."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and Safety of Inetetamab-Based Therapies in HER2-Positive Breast Cancer: A Systematic Review and Meta-Analysis (DGHO 2025) - "Inetetamab, a novel anti-HER2 monoclonal antibody, has shown promise as an alternative to trastuzumab, demonstrating comparable efficacy and safety in both neoadjuvant and metastatic settings. Inetetamab-based therapies demonstrate significant efficacy with a high CBR and ORR in HER2-positive breast cancer. While neutropenia and anemia are common adverse effects, their incidence is consistent with established HER2-targeted regimens. These findings support inetetamab as a viable therapeutic alternative, warranting further prospective validation to refine treatment protocols and enhance patient outcomes."

Retrospective data • Review • Anemia • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and Safety of Inetetamab-Containing Regimens in Patients with HER2-Positive Advanced Solid Tumors (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Shanghai Geriatric Medical Center; Shanghai Geriatric Medical Center

New trial • Solid Tumor • HER-2

Evaluating the Impact of Monoclonal Antibodies on Survival Outcomes in Advanced Gastric Cancer: A Systematic Review of RCTs (ACG 2025) - "Pembrolizumab plus chemotherapy also significantly enhances survival outcomes. In Boku et al., 2021, nivolumab demonstrated a significant OS benefit over placebo (5.3 vs 4.1 months) and a modest PFS benefit (1.61 vs 1.45 months). In Kong et al., 2024, inetetamab improved PFS compared to trastuzumab (8.5 vs 7.3 months, P = 0.046), but OS (15.4 vs 14.3 months) was not significantly different. Kang et al., 2024 reported that bemarituzumab plus mFOLFOX6 significantly improved both PFS (12.9 vs 8.2 months) and OS (24.7 vs 12.9 months) compared to placebo."

Metastases • Review • Gastric Cancer • Oncology • Solid Tumor

Personalized Treatment for Invasive Ductal Breast Carcinoma with Lung and Liver Metastases Based on Patient-Derived Organoids: A Case Report. (PubMed, Onco Targets Ther) - "After treatment with erebulin, carboplatin and inetetamab sensitive revealed by the organoid drug sensitivity testing, partial response in lung metastasis and stable disease in liver metastasis were achieved. This typical case suggests that for the individual patients with advanced refractory breast cancer, especially those exhausting the standard treatment options, the PDOs may serve as an effective model for assessing individual drug sensitivity to optimize treatment decisions and improve treatment response."

Journal • Breast Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A retrospective multicenter cohort study on the efficacy and safety of inetetamab and pyrotinib combined with chemotherapy (IPyC) for HER2+ metastatic breast cancer (ESMO 2025) - "Funding Fujian Provincial Health Technology Project (grant number: 2022GGB012). Table: 545P Characteristics 1st L 2nd L Higher L Median age (range), years 47 (26-65) 49 (27-78) 47 (27-74) ER/PR Positive 51 48 47 Negative 45 50 60 HER2 status IHC 3+ 69 80 91 IHC 2+ & FISH + 27 18 16 Previous anti-HER2 therapy H or HP only 53 92 15 H or HP combined with TKI 0 5 81 Naïve 43 0 0 ADCs 0 1 11 Tumor thrombus Yes 30 32 24 No 66 66 83 Multiple metastases <3 sites 65 60 44 ≥3 sites 31 38 63 Metastatic sites Visceral 60 71 88 Non-visceral 36 27 19 Trastuzumab resistance status Sensitivity 96 0 0 Resistance 0 98 107 TKI resistance status Sensitivity 96 73 18 Resistance 0 25 89 Conclusions IPyC regimen achieves durable disease control with manageable toxicity, offering a CNS-protective strategy. Legal entity responsible for the study The authors."

Metastases • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

The necessity of adding anti-HER2 antibody to TKI in trastuzumab-resistant, HER2-positive ABC: A multicenter real-world study (ESMO 2025) - "Methods This real-world study consecutively enrolled HER2-positive ABC patients treated with TKI alone or combined with antibody (inetetamab/trastuzumab) at 3 institutions (including the National Cancer Center, China) from October 2014 to April 2024. Further studies are warranted to identify the population that may benefit from the antibody-combined therapy. Legal entity responsible for the study Chinese Academy of Medical Sciences and Peking Union Medical College - National Cancer Center, Cancer Hospital."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

SHINE-HER: SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Fudan University

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

Real-world efficacy and safety of inetetamab-based therapy in HER2-positive metastatic breast cancer patients with prior exposure to trastuzumab. (PubMed, Front Oncol) - "The most common all-grade AEs were neutropenia (182/500, 36.4%) and leukopenia (157/500, 31.4%). Inetetamab was promising in HER2-positive MBC patients who had prior exposure to trastuzumab, offering a new option for patients with a prior failure of trastuzumab."

Journal • Real-world evidence • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

The efficacy and safety of neoadjuvant Ineteramab, Pertuzumab, Toripalimab and Paclitaxel in Patients With Her2-Positive Breast Cancer (A Single-Center Clinical Trial) (ChiCTR) - P4 | N=47 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-world efficacy and safety of inetetamab-based therapy in HER2-positive metastatic breast cancer patients with prior exposure to trastuzumab (Frontiers) - "A multicenter retrospective study collected clinicopathological data from a total of 500 patients between Jul 2020 and Oct 2023...In the overall cohort, we observed a median PFS of 8.0 months, an ORR of 28.6% and a DCR of 89.2% (median treatment line: third line). Meanwhile, patients who received a combination treatment regime of inetetamab + tyrosine kinase inhibitors (TKIs) + chemotherapy achieved the most prolonged PFS of 9.0 months and the higher ORR of 29.3%. Ki67 index, distant lymph nodes metastasis and treatment strategy were independent predictors of PFS. The most common all-grade AEs were neutropenia (182/500, 36.4%) and leukopenia (157/500, 31.4%).Inetetamab was promising in HER2-positive MBC patients who had prior exposure to trastuzumab, offering a new option for patients with a prior failure of trastuzumab."

Real-world • Real-world evidence • HER2 Positive Breast Cancer