Early Phase Unit – Institut Bergonié CLIP² shared on LinkedIn:
“First patient enrolled in EMBOLD-Sarcoma-202 under the French Fast Track framework.
Early Phase Unit – Institut Bergonié CLIP² at Institut Bergonié is proud to announce the enrollment of its first patient in the GSK300640 EMBOLD-Sarcoma-202 trial GSK, evaluating Risvutatug Rezetecan, a novel anti-B7H3 antibody-drug conjugate (ADC) in patients with sarcoma.
This study is among the first to benefit from the new French Fast Track initiative ANSM Agence nationale de sécurité du médicament et des produits de santé dedicated to highly innovative early-phase clinical trials.
The program was designed to accelerate regulatory evaluation and trial activation while maintaining the highest scientific, ethical, and safety standards.
This first inclusion reflects what can be achieved through close coordination between sponsors, regulatory authorities, ethics committees, clinical research teams, pharmacy, translational platforms, and referring physicians.
- Accelerated regulatory review
- Rapid study activation
- Efficient multidisciplinary coordination
- Early patient identification through molecular screening and referral networks
- Faster access to innovative therapies for patients with high unmet medical needs
At Institut Bergonié, this success also highlights the strength of our early-phase ecosystem, combining molecular screening, dedicated operational teams, translational research capabilities, and a regional and national referral network.
Most importantly, every acceleration in clinical development means a faster opportunity for patients to access promising new therapies. The Fast Track initiative is therefore not only a regulatory innovation – it is a patient-centered innovation.
By reducing study start-up timelines and increasing operational efficiency, France is strengthening its position in the international competition for early-phase clinical trials and reinforcing its attractiveness for the development of tomorrow’s treatments.
A special thank you to all the teams whose dedication, agility, and collaborative spirit made this milestone possible.
This first patient enrollment is the result of a remarkable collective effort across clinical, research, pharmacy, regulatory, operational, and support teams.”
To which Florent Peyraud, Medical Oncologist at Bergonié Institute, added:
“Proud to be part of this exciting innovation and to contribute to bringing promising new therapies to patients with sarcoma.
Congratulations to all teams involved for their outstanding collaboration, dedication, and agility in making this first patient enrollment possible.”
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