Clinical Trials

Preclinical and clinical results across multiple solid tumors with evidence of tumor response, local/peripheral immunomodulation, and minimal systemic toxicity.

Target:
Pancreatic Cancer

Completed

Trial of LSAM-PTX in Subjects with Locally Advanced Pancreatic Adenocarcinoma

This trial evaluates the safety, tolerability, and preliminary efficacy of LSAM-PTX injected intratumorally via endoscope-guided fine needle injection into patients with locally advanced pancreatic adenocarcinoma. A total of 54 patients were enrolled into the study.

Target:
Lung Cancer

Completed

Trial of LSAM-PTX Intratumoral Injection in Lung Cancer

This trial evaluates the safety, tolerability, and preliminary efficacy of up to three injections of LSAM-PTX administered into the lung tumors and lymph nodes of patients with lung cancer. A total of 18 patients were enrolled into the study.

Target:
Bladder Cancer

Completed

Evaluation of LSAM-DTX in Subjects with Urothelial Carcinoma

This trial evaluates the safety, tolerability, and preliminary efficacy of intramural/intravesical LSAM-DTX administered into patients with high-risk non-muscle invasive bladder cancer and muscle invasive bladder cancer. A total of 36 patients were enrolled into the study.

Target:
Pancreatic Mucinous-Cystic Neoplasm

Completed

Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of LSAM-PTX in Subjects With Mucinous Cystic Pancreatic Neoplasms

This trial evaluated the safety, tolerability, and preliminary efficacy of LSAM-PTX injected intracystically into patients with mucinous pancreatic cysts via endoscope-guided fine needle injection following aspiration of the cyst during the same procedure. A total of 19 patients were enrolled into the study.

Target:
Peritoneal Cancers

Completed

Trial of LSAM-PTX in Subjects with Peritoneal Cancers

This trial evaluated the safety, tolerability, and preliminary efficacy of LSAM-PTX administered via intraperitoneal (IP) infusion once every 28 days until disease progression or unacceptable toxicity. Patients with refractory malignancies principally confined to the peritoneal cavity were eligible for this study. A total of 22 patients were enrolled into the study.

Target:
Ovarian Cancers

Completed

Phase II Study of Intraperitoneal LSAM-PTX in Subjects with Ovarian Cancer

This trial evaluated the safety, tolerability, and preliminary efficacy of LSAM-PTX administered via intraperitoneally (IP) instillation at the end of post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy. Women with primary and recurrent ovarian cancer scheduled for cytoreductive surgery were eligible for this study. A total of 10 patients were enrolled into the study.

Target:
Prostate Cancers

Completed

Trial of LSAM-PTX Focal Therapy in Subjects with Prostate Cancer

This trial evaluated the safety, tolerability, and preliminary efficacy of a single injection of LSAM-PTX administered into the prostate lobe of men with prostate cancer four weeks prior to scheduled prostatectomy. A total of 16 patients were enrolled into the study.

Target:
Cutaneous Metastases

Completed

Study of Topical SOR007 for Cutaneous Metastases

This trial evaluated the safety, tolerability and preliminary efficacy of three concentrations (0.15%, 1.0%, and 2.0%) of SOR007 (topical submicron particle paclitaxel in anhydrous base) applied to patients with non-melanoma cutaneous metastases primarily of breast cancer. The trial included a dose escalation phase and continued into a dose expansion phase at the 2% strength. A total of 23 patients were enrolled into the study.