177Lu-DOTA-ibandronic acid (SKB107) / Sichuan Kelun Pharma - LARVOL DELTA

Safety and efficacy of the combination of hyperbaric oxygen and 177Lu-DOTA-IBA in treating metastatic bone pain due to tumors. (PubMed, Sci Rep) - "Hyperbaric oxygen combined with radionuclide therapy is safe and provides faster relief of bone pain in patients with bone metastases. Hyperbaric oxygen therapy can enhance the therapeutic effect of radionuclide therapy, and this combination warrants further evaluation for potential use in a clinical setting."

Journal • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

Unexpected Bilateral Lacrimal and Salivary Gland Uptake of 68Ga-DOTA-Ibandronic Acid on PET/CT. (PubMed, Clin Nucl Med) - "Unexpectedly, increased uptake was also noted in the bilateral lacrimal and salivary glands. This finding underscores the importance of evaluating potential radiation exposure to lacrimal and salivary glands before initiating 177Lu-DOTA-IBA-based radiopharmaceutical therapy."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Long-term Safety and Cumulative Efficacy of Multicycle 177Lu-DOTA-IBA Therapy in Bone Metastases: A Retrospective Cohort Study. (PubMed, Clin Nucl Med) - "For patients with bone metastases who can tolerate multicycle therapy, long-term 177Lu-DOTA-IBA treatment yields cumulative symptom improvement with no significant increase in cumulative toxicity risk, supporting its use as a long-term therapeutic strategy."

Journal • Retrospective data • Hematological Disorders • Oncology • Pain • Solid Tumor • Thrombocytopenia

Excellent Response to 177Lu-DOTA-IBA Therapy of Patients With Multiple Skeletal Metastases. (PubMed, Clin Nucl Med) - "No serious adverse events were observed in patients with multiple bone metastases who received 177Lu-DOTA-IBA. The therapeutic agent demonstrated promising efficacy, particularly for pain control and improved quality of life, suggesting that 177Lu-DOTA-IBA is a safe, effective therapeutic option for this population."

Journal • Hematological Disorders • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

[177Lu]Lu-DOTA-IBA plus EGFR-TKIs versus [177Lu]Lu-DOTA-IBA monotherapy for EGFR-mutated advanced non-small-cell lung cancer (NSCLC) with bone metastases: a prospective study. (PubMed, Eur J Nucl Med Mol Imaging) - No abstract available

Journal • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1 clinical stage (The Manila Times) - "SKB107 (RDC)[2]: The Phase 1 study is ongoing; SKB535/MK-6204 (novel ADC with potential FIC target): The Phase 1 clinical trial for SKB535 is ongoing in China; SKB445 (novel ADC with potential FIC target): The Phase 1 clinical trials for SKB445 is ongoing in China; SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China."

Trial status • Bone Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer • Pancreatic Cancer • Squamous Cell Carcinoma of Head and Neck

Revisiting the segmentation threshold for Lu-177 SPECT. (PubMed, Med Phys) - "An optimal 177Lu-specific threshold (∼50%) was derived and clinically validated, differing from the conventional 42% threshold used for 99mTc. The new threshold improved segmentation accuracy across different therapeutic radiopharmaceutical distributions."

Journal • Oncology

Safety and Efficacy Study of 225Ac-DOTA-IBA in the Treatment of Bone Metastases. (PubMed, Clin Nucl Med) - "This study indicated that 225Ac-DOTA-IBA was a promising and well-tolerated therapeutic for bone metastases, demonstrating acceptable toxicity and notable efficacy, including 177Lu-DOTA-IBA-refractory cases. Subgroup analyses indicated that patients with bone-only metastases derived particular clinical benefit."

Journal • Oncology • Pain • Solid Tumor

Remarkable Response to 177Lu-PSMA and 177Lu-DOTA-IBA Cocktail Therapy in a Patient With Dual Primary Malignancies. (PubMed, Clin Nucl Med) - "A patient with metastatic atypical right lung carcinoid underwent 68Ga-FAP2286 and 68Ga-DOTATATE PET/CT scans to assess eligibility for radionuclide therapy, which revealed insufficient coverage of all lesions by either tracer. Guided by these multimodal imaging, the patient received combined 177Lu-PSMA and 177Lu-DOTA-IBA therapy. Notably, he achieved near-complete remission of both primary malignancies and all metastases after one cycle of cocktail therapy and one cycle of 177Lu-DOTA-IBA therapy."

Journal • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

An Exploratory Study of 177Lu-PSMA-617 in Combination with 177Lu-TBM-001 for the Treatment (Cocktail Therapy) of Metastatic Chemoresistant Prostate Cancer (mCRPC) (ChiCTR) - P=N/A | N=30 | Recruiting | Sponsor: West Southwest Medical University Affiliated Hospital; West Southwest Medical University Affiliated Hospital

New trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SKB107: (PRNewswire) - "A RDC drug jointly developed by the Company and the Affiliated Hospital of Southwest Medical University...targeting bone metastases in solid tumors. In March 2025, an IND application for SKB107 was approved by the NMPA and the Phase 1 study is ongoing."

Trial status • Solid Tumor

Kelun-Biotech’s Radionuclide-Drug Conjugate (RDC) SKB107 Receives NMPA Approval For The Treatment of Bone Metastases in Solid Tumors (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical...announced that the Company has received a clinical trial notice approving the investigational new drug application for a radionuclide-drug conjugate (RDC) drug SKB107 (formerly TBM-001) from the Center for Drug Evaluation of the National Medical Products Administration. SKB107 is the first company RDC drug clinical project....It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be used for treatment of bone metastases in solid tumors"

New trial • Solid Tumor