Bizengri: how was the first human dose set?

The public FDA and EMA reviews of Bizengri don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

ADCs with cytotoxic payloads follow the S9 rules (1/10 STD10 or 1/6 HNSTD of the ADC, scaled by body surface area). For immune agonists, a MABEL-based start dose should be considered instead.

NOAEL / key findings: NOAEL 100 mg/kg/wk (1-month) and 101 mg/kg/wk (13-week) per applicant; FDA noted 2 early deaths/moribund, immune-mediated infusion reaction, GI lesions, skin, adrenal (FDA multi-discipline review, p. 58)

Full method, every step sourced →