ARC101 / Third Arc Bio - LARVOL DELTA

Overcoming claudin family homology: discovery of ARC101, a highly potent CLDN6-specific T-cell engager with a novel CD3 binder for ovarian adenocarcinoma. (PubMed, MAbs) - "ARC101 also demonstrated a favorable pharmacokinetic profile in cynomolgus monkeys, low immunostimulatory responses in ex vivo human donor assays, and robust biophysical properties compatible with standard antibody manufacturing. Collectively, these findings support the clinical advancement of ARC101 as a differentiated, CLDN6-specific bispecific immunotherapy with exceptional tumor selectivity and optimized T cell activity for the treatment of solid tumors."

IO biomarker • Journal • Oncology • Ovarian Cancer • Solid Tumor • CLDN6

ARC101-P1-101: A first-in-human phase 1 study of ARC101, a next generation T cell engager (TCE), in patients with advanced solid tumors. (ASCO 2025) - P1 | "The study is actively enrolling participants for the dose escalation phase. Contact clinicaltrials@thirdarcbio for additional information."

Clinical • IO biomarker • Metastases • P1 data • Oncology • Ovarian Cancer • Solid Tumor • CLDN6

Pharmacologic characterization of a highly specific and potent CLDN6xCD3 T cell engager (TCE), ARC101, for the treatment of CLDN6+ cancers (AACR 2025) - P1 | "Overall, ARC101 is a highly specific CLDN6-directed T-cell engager with significant therapeutic potential for CLDN6-positive solid tumors. A Phase 1 first-in-human (FIH) clinical trial of ARC101 (NCT06672185) is planned to commence in 2025."

Endometrial Cancer • Epithelial Ovarian Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN4 • CLDN6

Third Arc Bio Announces First Patient Dosed in Phase 1 Clinical Trial of Lead T Cell Engager ARC101 to Treat CLDN6 Positive Cancers (PRNewswire) - "Third Arc Bio Inc...today announced the first patient has been dosed in its first-in-human study evaluating ARC101, a potential best-in-class T cell engager targeting Claudin 6 (CLDN6). This Phase 1 study will evaluate the optimal dosing, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor efficacy of ARC101 as monotherapy in patients with locally advanced or metastatic solid tumors expressing CLDN6...Third Arc Bio will present a poster highlighting preclinical results for ARC101 at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting."

Preclinical • Trial status • Oncology • Solid Tumor

ARC101 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Third Arc Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor