Nuvation Bio has dosed the first subject in a Phase I/II clinical trial of NUV-1511, a new drug-drug conjugate (DDC) aimed at treating advanced solid tumours.
This marks a significant step for the biopharmaceutical company, which focuses on developing innovative oncology therapies.
NUV-1511 is claimed to be the first DDC of the company to enter clinical trials.
The flexible design of the dose escalation portion of the study will explore two dosing regimens of the DDC to establish the recommended Phase II dose.
The trial will assess the tolerability, safety, and pharmacokinetic profile of NUV-1511 during the initial stage.
It will also evaluate the signs of clinical activity in people with advanced solid tumours who were priorly treated and advanced on or following treatment with Enhertu and/or Trodelvy per approved US Food and Drug Administration (FDA) labelling.
The trial will also involve individuals with human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC).
Earlier this year, Nuvation Bio received FDA clearance for an investigational new drug application to evaluate NUV-1511.
Since its founding in 2018, the company has developed a portfolio of oncology therapeutic candidates designed to target some of the most challenging types of cancer.
Nuvation Bio founder, president and CEO David Hung said: “Dosing the first patient with NUV-1511 marks a significant milestone for our proprietary DDC platform, from which we are developing potent oncology-focused chimeric small molecules designed to selectively deliver anti-cancer therapeutics to cancer cells while mitigating effects on healthy non-target tissues.
“DDCs are the core technology upon which the company was founded and we are excited to bring our first DDC clinical candidate to patients.”
Apart from NUV-1511, the company has another asset, NUV-868, which is a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor.
Nuvation Bio concluded a Phase I monotherapy dose escalation trial of NUV-868 and established a maximum tolerated dose in advanced solid tumour patients.
