RS-0139 / RS Research - LARVOL DELTA

Phase 1a dose-escalation study of RS-0139: A novel tumor-targeted nanomedicine for advanced solid tumors. (ASCO 2025) - P1 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT04261413 Background: RS-0139 is a tumor-targeted prodrug designed to enhance the therapeutic index of docetaxel (DTX) by selectively delivering the active agent to tumor tissues... RS-0139 exhibited a manageable safety profile at 60 mg/m², with no DLTs reported. The IDMC identified DL 1 as the MTD and recommended DL -1 as the optimal dose for Ph1b. The prolonged half-life and elevated AUC indicate the potential for improved efficacy at lower doses."

Metastases • P1 data • Endometrial Cancer • Fatigue • Febrile Neutropenia • Lung Cancer • Musculoskeletal Pain • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Solid Tumor • Thrombocytopenia

Phase Ia/Ib Study of RS-0139 in Patients with a Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S. | Trial completion date: Aug 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Oct 2025

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

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.

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

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S. | Phase classification: P1a/1b ➔ P1

Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

RS-0139, a novel tumor-targeted delivery of docetaxel, with potent anti-tumor activity in a broad spectrum of tumor cell lines and xenograft models (ESMO-TAT 2023) - "Conclusions Tumor cell expression of the integrins is correlated with disease progression in various tumor types such as breast, pancreatic, prostate, non-small cell lung cancers and glioblastoma. Preclinical studies demonstrate promising results for NSCL, breast and prostate cancers."

Preclinical • Tumor cell • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1a/1b | N=16 | Recruiting | Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S. | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

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

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1a/1b | N=16 | Recruiting | Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S. | Trial completion date: Jan 2023 ➔ Aug 2023 | Trial primary completion date: Sep 2022 ➔ Jun 2023

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

Phase Ia/Ib study of RS-0139, a novel tumor-targeted delivery of docetaxel, in patients with recurrent, locally advanced, or metastatic non-small cell lung cancer (NSCLC) (ESMO 2022) - P1a/1b | "The study is open for enrollment in 2 sites. Two of the planned 16 patients have been enrolled to date."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1a/1b; N=16; Recruiting; Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.; Trial completion date: Jun 2022 ➔ Jan 2023; Trial primary completion date: Feb 2022 ➔ Sep 2022

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

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1a/1b; N=16; Recruiting; Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1a/1b; N=16; Not yet recruiting; Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.; Trial completion date: Apr 2021 ➔ Nov 2021; Initiation date: Apr 2020 ➔ Nov 2020; Trial primary completion date: Jan 2021 ➔ Jul 2021

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

Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1a/1b; N=16; Not yet recruiting; Sponsor: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.

Clinical • New P1 trial