177Lu HTK03170 / BC Cancer Agency - LARVOL DELTA

First in human evaluation of 177Lu-HTK03170: Biodistribution and dosimetry in patients with mCRPC (SNMMI 2025) - P1/2 | "The highest activity levels in the kidneys, salivary glands and tumors were observed at 27.7 hours p.i (Fig. 1), however, the washout rates varied across these tissues. In the kidneys, peak uptake reached 3.4 ± 1.3 × 10-2 %IA/g at 27.7 h p.i., with an effective half-life of 39.3 h. Uptake in the parotid and submandibular glands was notably lower, measured at 1.6 ± 0.8 × 10-2 %IA/g and 1.9 ± 1.2 × 10-2 %IA/g, respectively, at 27.7 h p.i., with effective half-lives of 62.0 and 62.7 h. Tumor uptake was 13.4 ± 17.4 × 10-2 %IA/g at 27.7 h p.i. exhibiting the longest washout effective half-life of 95.1 h. Our preliminary results indicated that the kidneys, salivary glands, and red marrow experienced the highest AD among the assessed normal tissues, with the kidneys having the highest AD."

Clinical • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Salivary Gland Cancer • Solid Tumor

First in human evaluation of 177Lu-HTK03170: Biodistribution and dosimetry in patients with mCRPC (SNMMI 2025) - P1/2 | "The highest activity levels in the kidneys, salivary glands and tumors were observed at 27.7 hours p.i (Fig. 1), however, the washout rates varied across these tissues. In the kidneys, peak uptake reached 3.4 ± 1.3 × 10-2 %IA/g at 27.7 h p.i., with an effective half-life of 39.3 h. Uptake in the parotid and submandibular glands was notably lower, measured at 1.6 ± 0.8 × 10-2 %IA/g and 1.9 ± 1.2 × 10-2 %IA/g, respectively, at 27.7 h p.i., with effective half-lives of 62.0 and 62.7 h. Tumor uptake was 13.4 ± 17.4 × 10-2 %IA/g at 27.7 h p.i. exhibiting the longest washout effective half-life of 95.1 h. Our preliminary results indicated that the kidneys, salivary glands, and red marrow experienced the highest AD among the assessed normal tissues, with the kidneys having the highest AD."

Clinical • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Salivary Gland Cancer • Solid Tumor

First in human evaluation of 177Lu-HTK03170: Biodistribution and dosimetry in patients with mCRPC (SNMMI 2025) - P1/2 | "The highest activity levels in the kidneys, salivary glands and tumors were observed at 27.7 hours p.i (Fig. 1), however, the washout rates varied across these tissues. In the kidneys, peak uptake reached 3.4 ± 1.3 × 10-2 %IA/g at 27.7 h p.i., with an effective half-life of 39.3 h. Uptake in the parotid and submandibular glands was notably lower, measured at 1.6 ± 0.8 × 10-2 %IA/g and 1.9 ± 1.2 × 10-2 %IA/g, respectively, at 27.7 h p.i., with effective half-lives of 62.0 and 62.7 h. Tumor uptake was 13.4 ± 17.4 × 10-2 %IA/g at 27.7 h p.i. exhibiting the longest washout effective half-life of 95.1 h. Our preliminary results indicated that the kidneys, salivary glands, and red marrow experienced the highest AD among the assessed normal tissues, with the kidneys having the highest AD."

Clinical • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Salivary Gland Cancer • Solid Tumor

Comparison of Extrapolation Methods for Animal-to-Human Dosimetry of PSMA targeting agents: 177Lu-HTK03170 and 177Lu-PSMA-617 (SNMMI 2025) - P1/2, P2 | "For 177Lu-HTK03170, M3 delivered the most accurate kidney AD prediction, achieving a ratio of 0.95 with the mean patient data, while M1 performed better for bone marrow (ratio 0.40) and M6 for salivary glands (ratio 0.46). In contrast, for 177Lu-PSMA-617, M4 yielded the best prediction for kidney AD (ratio 1.27), while M5 provided a closer estimate for bone marrow and salivary glands with ratios 0.76 and 0.40, respectively. Despite variations in accuracy (Fig."

Oncology

The 177Lu-HTK03170 Trial at the BC Cancer Center (SNMMI 2025) - "Sponsored by Dosimetry Task Force"

Oncology

Comparison of Extrapolation Methods for Animal-to-Human Dosimetry of PSMA targeting agents: 177Lu-HTK03170 and 177Lu-PSMA-617 (PSMA 2025) - No abstract available

First in human evaluation of 177Lu-HTK03170: Biodistribution and dosimetry in patients with mCRPC (PSMA 2025) - No abstract available

Clinical • P1 data • Castration-Resistant Prostate Cancer • Prostate Cancer

177Lu-HTK03170 in MCRPC with PSMA Positive Disease (clinicaltrials.gov) - P1/2 | N=50 | Suspended | Sponsor: British Columbia Cancer Agency | Recruiting ➔ Suspended

Trial suspension • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

177Lu-HTK03170 in mCRPC With PSMA Positive Disease (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: British Columbia Cancer Agency | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

177Lu-HTK03170 in mCRPC With PSMA Positive Disease (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: British Columbia Cancer Agency | Initiation date: Mar 2023 ➔ Oct 2023

Metastases • Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

177Lu-HTK03170 in mCRPC With PSMA Positive Disease (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: British Columbia Cancer Agency | Trial completion date: Dec 2027 ➔ May 2027 | Initiation date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2026 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

177Lu-HTK03170 in mCRPC With PSMA Positive Disease (clinicaltrials.gov) - P1/2 | N=56 | Not yet recruiting | Sponsor: British Columbia Cancer Agency

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor