ROSE12 / Roche - LARVOL DELTA

RSE101CT: A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=209 | Recruiting | Sponsor: Chugai Pharmaceutical | Trial completion date: Dec 2026 ➔ Oct 2027 | Trial primary completion date: Dec 2026 ➔ Oct 2027

Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ROSE12, a novel anti-CTLA-4 Switch antibody™ with FcγR affinity-enhanced Fc, evokes tumor-selective anti-tumor immune activation by extracellular ATP without systemic immune activation (AACR 2025) - P1 | "We also evaluated mROSE12 and FcγR affinity-enhanced ipilimumab (Ipi-ART)'s intratumoral Treg depletion and T cell activation in non-tumor tissues using flow cytometry. ROSE12 showed ATP-dependent binding to CTLA-4 and stronger FcγRIIIa-affinity than ipilimumab-NF. ROSE12 is a novel FcγR affinity-enhanced anti-CTLA-4 Switch antibody™ with potent anti-tumor efficacy and a wide therapeutic window due to tumor-selective activity. These results strongly support the clinical testing of ROSE12 in the treatment of solid tumors. Currently, ROSE12 is undergoing a phase 1 clinical study (NCT05907980)."

Oncology • Solid Tumor

Preclinical evaluation of toxicity reduction for ROSE12, a novel ATP-dependent anti-CTLA-4 Switch antibody™ with FcγR affinity-enhanced Fc (AACR 2025) - P1 | "Our study suggests that ROSE12, which has ATP dependency, may mitigate colonic toxicity by avoiding the depletion of Tregs in colon lamina propria. Thus, ROSE12 may show a wide therapeutic window. A phase I clinical trial for patients with solid tumors is ongoing (NCT05907980)."

Preclinical • Oncology • Solid Tumor

ROSE12, a novel anti-CTLA-4 FcγRs binding-enhanced antibody activated by extracellular adenosine triphosphate, shows tumor-selective regulatory T-cell depletion and antitumor efficacy without systemic immune activation. (PubMed, J Immunother Cancer) - P1 | "These findings support the clinical development of ROSE12 as a tumor-selective Treg-depleting immunotherapy with potential efficacy in programmed cell death protein-1/PD-L1 therapy-resistant patients. The favorable safety profile was attributed to the ATP-dependent binding mechanism that restricts activity to the high-ATP tumor microenvironment. ROSE12 is currently being evaluated in phase I clinical trials (NCT05907980)."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Oncology • Solid Tumor • CD8

ROSE12, a novel anti-CTLA-4 switch antibody with FcγR affinity-enhanced Fc, evokes tumor-selective anti-tumor immune response, activated by extracellular ATP in tumor microenvironment (SITC 2024) - P1 | "We also evaluated intratumoral Treg depletion and T cell activation in non-tumor tissues using flow cytometry in CTLA-4KI mice treated with mROSE12 and FcγR affinity-enhanced ipilimumab. Ethics Approval All animal studies were reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). All studies using human material were approved by Chugai Pharmaceutical Co., Ltd.'s Research Ethics Committee."

Biomarker • Tumor microenvironment • Oncology • Solid Tumor

A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=219 | Recruiting | Sponsor: Chugai Pharmaceutical

Combination therapy • Metastases • New P1 trial • Oncology • Solid Tumor