Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

  Measured over: Through end of treatment, up to approximately 1 year.

• Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)

  Measured over: At the end of Cycle 1 (each cycle is 21 days)

• Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Measured over: Through end of treatment, up to approximately 1 year.

• Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter

  Measured over: Cycles 1 to 3 (each cycle is 21 days)

• Part L - Peak Plasma Concentration (Cmax) of Rina-S

  Measured over: Cycles 1 and 2 (each cycle is 21 days)

• Part L - Area Under the Plasma Concentration Versus Time Curve (AUC) of Rina-S

  Measured over: Cycles 1 and 2 (each cycle is 21 days)

Changes Tremor has spotted