Eligible patients were adults with advanced melanoma (Stage III/IV) resistant to prior therapies, adequate organ function, and measurable disease. Exclusions included recent anticancer treatments (21 days for cytotoxic/antibody therapies), active infections, CNS metastases, prior MMAE-ADC treatment, or significant comorbidities.

DEDN6526A (0.3-2.8 mg/kg) was given intravenously every 3 weeks (q3w) to pts with metastatic or unresectable cutaneous, mucosal, or ocular (uveal) melanoma in a 3+3 design to determine the maximum-tolerated dose, followed by cohort expansion at the recommended phase II dose (RP2D).

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Safety evaluation included ongoing monitoring of adverse events (up to 90 days post-treatment), determination of maximum tolerated dose/dose-limiting toxicities, and establishment of recommended Phase II dose over approximately 2 years.

Pharmacokinetic assessments covered concentration-time curve analysis and anti-therapeutic antibody monitoring during treatment cycles, with tumor response evaluated via RECIST criteria for approximately 1 year.

Eligibility requires adult Stage III/IV melanoma patients (ECOG 0-1, failed ≥1 prior therapies) with adequate organ function. Key exclusions include recent anticancer treatments (21-day washout), active CNS metastases, Grade ≥2 toxicities, MMAE-ADC exposure, or uncontrolled comorbidities. Contraception is mandated for 6 months post-treatment.

DEDN6526A (0.3-2.8 mg/kg) was given intravenously every 3 weeks (q3w) to pts with metastatic or unresectable cutaneous, mucosal, or ocular (uveal) melanoma in a 3+3 design to determine the maximum-tolerated dose, followed by cohort expansion at the recommended phase II dose (RP2D).

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Safety will be continuously monitored for adverse events through 90 days post-treatment, while dose-limiting toxicities and MTD will be evaluated over one year to establish the recommended Phase II dose within approximately two years.

PK parameters including AUC will be assessed through serial sampling (pre/post-dose during Cycles 1-5), alongside ATA monitoring and tumor response evaluations per RECIST criteria for approximately one year.