LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Belong to the Master protocol, LIGHTBEAM-U01 Master Protocol: A Phase 1/2 Platform Study to Evaluate the Safety and Efficacy of Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors.

Substudy 01C primary objectives:

Part 1: To evaluate the safety and tolerability and to establish a preliminary RP2D of patritumab deruxtecan (HER3-DXd)
Part 1: To characterize the PK of HER3-DXd
Part 1 and Part 2: To evaluate the preliminary antitumor effect of HER3-DXd in terms of ORR according to RECIST 1.1 per investigator assessment by tumor type

Substudy 01C secondary objectives:

Part 2: To evaluate the safety and tolerability of HER3-DXd
Part 1 and Part 2: To evaluate the preliminary antitumor effect of HER3-DXd in terms of DCR, TTR, DOR, and PFS according to RECIST 1.1 per investigator assessment by tumor type
Part 1 and Part 2: To evaluate OS by tumor type
Part 2: To characterize the PK of HER3-DXd

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