Our Priorities

Dedicated to Developing New Treatment Options Safely and Responsibly

At Kyntra Bio, we are dedicated to advancing first-in-class medicines that have the potential to provide new and effective treatment options for the patients in need.

Before a new treatment becomes widely available, it must undergo rigorous testing through extensive preclinical and clinical studies. These studies are carefully conducted in accordance with guidelines set by the U.S. Food and Drug Administration (FDA) and other regulatory authorities outside of the U.S. The purpose of clinical trials is to evaluate the safety and effectiveness of promising new therapeutics.

Patients who participate in clinical trials may gain early access to investigational treatments and play an important role in helping researchers and clinicians answer key questions about potential new products.

Clinical researchers discussing Kyntra Bio clinical trials

FG-3246 + FG-3180 Trials

FG-3246 is a potential first-in-class, fully human ADC targeting CD46, currently in Phase 2 development for mCRPC. It holds potential for additional investigation targeting other CD46-expressing cancers. As part of the ongoing Phase 2 study, Kyntra Bio is also evaluating FG-3180, a CD46-targeted PET imaging agent, in an exploratory sub study to assess its ability to detect CD46-positive lesions and support predictive patient selection.

Participating in Clinical Trials

We believe that participating in our clinical trials is the best way for patients to potentially access our investigational medicines prior to regulatory approval. To explore available trials, please review the information found on this website or visit www.clinicaltrials.gov. If you identify a study of interest, you or your physician may contact the participating site directly to inquire about enrollment.

In exceptional circumstances where clinical trial participation is not possible, and no alternative therapies are available to treat the patient’s disease or condition, the patient’s physician may request access to one of our investigational drugs on humanitarian grounds. These requests are sometimes referred to as “expanded access” or “compassionate use,” although terminology may vary. For details about our expanded access policy or to submit a request, please contact us here.