FDA Clears Investigational New Drug Application for Metastatic Castration-Resistant Prostate Cancer Treatment


Blue Earth Therapeutics will begin an open-label, multicenter trial to evaluate a next-generation radiopharmaceutical for metastatic castration-resistant prostate cancer.

The FDA has authorized an investigational new drug (IND) application for 177Lu-rhPSMA-10.1 for the treatment of metastatic castration-resistant prostate cancer (mCRPC), according to a press release from Blue Earth Therapeutics.

Clearance of the IND allows Blue Earth Therapeutics to begin an open-label, multicenter, phase 1/2 trial to evaluate the safety, tolerability, dosimetry, and antitumor activity of 177Lu-rhPSMA-10.1, a next-generation radiopharmaceutical, in patients with mCRPC.

“Clearance to proceed with this first clinical study for 177Lu-rhPSMA-10.1 marks an exciting milestone for our new company, Blue Earth Therapeutics, and the patients with cancer that we hope to serve,” said David E. Gauden, DPhil, chief executive officer of Blue Earth Therapeutics, in the press release. “We consider 177Lu-rhPSMA-10.1 to be a next-generation prostate-specific membrane antigen [PSMA] therapy with the potential to be best-in-class.”

Radiohybrid PSMA (RhPSMA) compounds are made up of 3 distinct domains. This first of which includes a PSMA-targeted receptor ligand that attaches to 2 labelling moieties that could be radiolabeled with 18F for PET imaging or isotopes, such as 177Lu or 225Ac, according to Blue Earth. The technology could play a vital role in the future management of patients with prostate cancer, potentially presenting an opportunity to use precision medicine to treat the disease. To date, no rhPSMA compounds have gained FDA approval.

177Lu-rhPSMA-10.1 is the result of a careful optimization process which aimed to maximize therapeutic index by delivering high radiation doses to prostate cancer lesions while sparing normal tissues wherever possible,” Gauden said.

The phase 1 portion of the trial will analyze the safety, tolerability, and dosimetry of several cycles of 177Lu-rhPSMA-10.1 in patients with PSMA-positive mCRPC who experienced disease progression after previous treatment. Data from the phase 1 portion of the trial will be used to identify the recommended treatment regimen for further evaluation in the phase 2 part of the trial.

The phase 1 study will be conducted at clinical sites in the United States, with additional sites expected to be added in the United States and Europe during the phase 2 portion of the trial.

“We look forward initially to applying our proven radiopharmaceutical development expertise in advancing 177Lu-rhPSMA-10.1, and, over time, developing a pipeline of additional oncology therapeutics to help address significant unmet patient needs,” Gauden said.


Blue Earth Therapeutics announces US FDA clearance for investigational new drug (IND) application for 177Lu-rhPSMA-10.1 for treatment of prostate cancer. News release. Blue Earth Therapeutics; April 12, 2022. Accessed April 12, 2022. https://bit.ly/3JExLRc

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