Corbus Pharmaceuticals Holdings Inc CRBP announced that data from the first-in-human clinical study of CRB-701 (SYS6002) is being presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium.
The Phase 1 dose escalation study is being conducted in China and is enrolling participants with metastatic urothelial cancer (mUC) as well as participants with other solid tumors prospectively confirmed to have nectin-4 positive tumors.
The study opened for enrollment in January 2023, and data through December 2023 from the first eighteen participants reflective of the first six dose cohorts (0.2-3.6mg/kg) will be shared.
Dose level 5 (2.7 mg/kg) and above represents the predicted therapeutically relevant doses based on allometric scaling.
A mixed tumor population (n=7) receiving doses of 2.7 mg/kg or 3.6 mg/kg demonstrated an ORR of 43% (3 partial responses -2 unconfirmed and one non-responding participant with no-nectin-4 expression) and a disease control rate of 71%.
The longest observed response to date is 11 cycles (~10 months) and ongoing.
Single-dose PK suggested that TAb, ADC, and MMAE increase in an approximate dose-proportional manner. No obvious accumulation was observed on cycle 3, day 1.
Compared to the exposures achieved with enfortumab vedotin (EV) at 1.25 mg/kg Q1W x21 days, CRB-701 (SYS6002) consistently demonstrated lower free MMAE concentrations.
CRB-701 was well-tolerated, with most adverse events being grade one or two and reversible. No adverse events above grade three were observed.
The dose escalation is ongoing at cohort 7 (4.5 mg/kg).
No cases of drug-related peripheral neuropathy or skin rash have been reported to date.
Price Action: CRBP shares are up 257.80% at $30.20 on the last check Friday.
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