TRK-950 / Toray - LARVOL DELTA

A Study of TRK-950 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=49 | Recruiting | Sponsor: Toray Industries, Inc | Active, not recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

Radiopharmaceutical application of TRK-950, an anti-CAPRIN-1 therapeutic antibody (AACR-NCI-EORTC 2025) - "Furthermore, these results were also observed in the 4T1 tumor-bearing model with radiolabeled TRK-950-F(ab')2, which has shorter pharmacokinetics. Additionally, dosimetry data indicated that the radiation-related biological risk of radiolabeled TRK-950 in human is expected to be clinically acceptable.Conclusion This study demonstrates that radiopharmaceuticals targeting CAPRIN-1, including radiolabeled TRK-950 and TRK-950-F(ab')2, have high potential as radiopharmaceuticals."

Late-breaking abstract • Oncology • Solid Tumor • CAPRIN1

A Study of TRK-950 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: Toray Industries, Inc | Phase classification: P1 ➔ P1/2 | N=13 ➔ 49

Enrollment change • Phase classification • Melanoma • Oncology • Solid Tumor

A Study of TRK-950 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: Toray Industries, Inc | Trial completion date: Jun 2025 ➔ Dec 2027 | Trial primary completion date: Jun 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Solid Tumor

Phase I first-in-human Study of TRK-950, an IgG1 Antibody Specific to CAPRIN-1, in Patients with Advanced Solid Tumors. (PubMed, Cancer Res Commun) - "TRK-950 is safe and well tolerated, has a favorable PK profile, and should be further investigated as a monotherapy and in combination with standard treatment for various types of solid tumors."

Journal • P1 data • Back Pain • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • CAPRIN1

Radiopharmaceutical application of TRK-950, an anti-CAPRIN-1 therapeutic antibody. (PubMed, J Cancer Res Clin Oncol) - "This study demonstrates that radiopharmaceuticals targeting CAPRIN-1, including radiolabeled TRK-950 and TRK-950-F(ab')2, have high potential as radiopharmaceuticals."

Journal • Oncology • Solid Tumor • CAPRIN1

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=187 | Active, not recruiting | Sponsor: Toray Industries, Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Gastric Cancer • Genito-urinary Cancer • Melanoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor

Development and validation of an antidrug antibody assay for TRK-950 using Melon™ gel and SPEAD pretreatment. (PubMed, Bioanalysis) - P1 | "Clinical trials (NCT05423262) employing this improved analytical method have been conducted, and the results confirm the low immunogenicity of TRK-950. The combination of pretreatment with Melon™ gel and SPEAD is applicable for clinical ADA assays."

Journal • Oncology • Solid Tumor • CAPRIN1

A Study of TRK-950 in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: Toray Industries, Inc | Trial completion date: Feb 2025 ➔ Jun 2025 | Trial primary completion date: Feb 2025 ➔ Jun 2025

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

Bolt Biotherapeutics, Inc. Provides Update on Global Cancer Immunotherapy Co-Development with Toray Industries, Inc. (GlobeNewswire) - "Bolt Biotherapeutics, Inc., announced today that the target of their worldwide co-development collaboration with Toray Industries, Inc. is Caprin-1, a novel cancer target discovered by Toray. The collaborators are developing a Boltbody Immune-Stimulating Antibody Conjugate (ISAC) targeting Caprin-1, which is applicable to multiple solid tumor types. Under the existing Joint Development and License Agreement, Toray supplies its proprietary antibodies targeting Caprin-1, such as the antibody TRK-950, and Bolt contributes proprietary linker-payloads from its Boltbody ISAC platform technology. Bolt plans to co-develop and jointly commercialize the resulting ISAC product candidate with Toray."

Licensing / partnership • Solid Tumor

A Study of TRK-950 When Used in Combination with Ramucirumab and Paclitaxel in Patients with Gastric Cancer (clinicaltrials.gov) - P2 | N=146 | Recruiting | Sponsor: Toray Industries, Inc | Trial completion date: Aug 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CAPRIN1

A Study of TRK-950 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: Toray Industries, Inc | Recruiting ➔ Active, not recruiting | N=19 ➔ 13

Enrollment change • Enrollment closed • Metastases • Oncology • Solid Tumor

A randomized, multicenter, open-label, phase 2 study of TRK-950 in combination with ramucirumab and paclitaxel as second-line therapy in patients with Caprin-1 positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. (ASCO 2024) - P1, P2 | "41, No. 4, suppl."

Clinical • Combination therapy • P2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CAPRIN1 • HER-2

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=187 | Recruiting | Sponsor: Toray Industries, Inc | Trial completion date: Aug 2024 ➔ Mar 2025 | Trial primary completion date: Aug 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Melanoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor

A Study of TRK-950 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: Toray Industries, Inc | Active, not recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A randomized, multicenter, open-label, phase 2 study of TRK-950 in combination with ramucirumab and paclitaxel as second-line therapy in patients with CAPRIN-1 positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. (ASCO-GI 2024) - P1, P2 | "4, suppl. Clinical trial information: NCT06038578."

Clinical • Combination therapy • P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CAPRIN1 • HER-2

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=169 | Recruiting | Sponsor: Toray Industries, Inc

Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Melanoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor

A Study of TRK-950 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: Toray Industries, Inc

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=169 | Recruiting | Sponsor: Toray Industries, Inc | Phase classification: P1b ➔ P1

Metastases • Phase classification • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Melanoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor

A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer (clinicaltrials.gov) - P2 | N=146 | Not yet recruiting | Sponsor: Toray Industries, Inc

Combination therapy • New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CAPRIN1

A Study of TRK-950 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: Toray Industries, Inc | Trial completion date: Jul 2023 ➔ Dec 2023 | Trial primary completion date: Jul 2023 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer (clinicaltrials.gov) - P2 | N=146 | Recruiting | Sponsor: Toray Industries, Inc | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CAPRIN1

Phase 2 trial of Caprin-1 targeting antibody TRK-950 in combination with ramucirumab/paclitaxel begins for second-line treatment of advanced gastric cancer (Korea Biomedical Review) - "On August 30, Toray announced that it will conduct an international, open-label, phase 2 study in the United States, Japan, and South Korea targeting gastric cancer patients for TRK-950, a monoclonal antibody against Caprin-1, a novel cancer therapeutic target discovered by the company announced that it would start....The phase 2 study is a randomized controlled trial targeting patients with gastric cancer that strongly expresses Caprin-1, with one group receiving TRK-950 in combination with ramucirumab and paclitaxel and another group receiving ramucirumab and paclitaxel as second-line treatments for advanced gastric cancer....The company has received approval to conduct the trial from the U.S. Food and Drug Administration (FDA), and has completed the submission of a clinical trial plan in Japan. Currently under review in Korea."

IND • New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Identification of Membrane-expressed CAPRIN-1 as a Novel and Universal Cancer Target, and Generation of a Therapeutic Anti-CAPRIN-1 Antibody TRK-950. (PubMed, Cancer Res Commun) - P1, P1b | "Here, we have successfully identified CAPRIN-1 as a novel truly cancer-specific target, universally expressed on membranes of various cancer cells including cancer stem cells. Clinical studies are underway for the anti-CAPRIN-1 therapeutic antibody TRK-950."

Journal • Oncology • Solid Tumor • CAPRIN1

Identification of membrane-expressed CAPRIN-1 as a novel and universal cancer target and generation of a therapeutic anti-CAPRIN-1 antibody TRK-950 (AACR 2023) - P1, P1b | "Together our data demonstrate that CAPRIN-1 is a novel and universal target for cancer therapies. A phase I clinical study of TRK-950 (NCT02990481) has been completed and a phase Ib study (combination with approved drugs) is currently underway (NCT03872947)."

Oncology • Solid Tumor • CAPRIN1