Sponsor: MBrace Therapeutics, Inc.
Sponsor Study ID: MBRC-101-001
Study Title: A Multicenter, Open-Label Phase 1/1B Dose-Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EPHA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors
CTO #: 103990
NCT Number: NCT06014658
Phase: I
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Bladder; Breast; Colon; Esophagus; Kidney; Larynx; Lip, Oral Cavity and Pharynx; Liver; Lung; Melanoma, Skin; Ovary; Pancreas; Prostate; Rectum; Small Intestine; Soft Tissue; Stomach; Thyroid
Study Objectives: To identify potential OBRD and dosing regimens of MBRC-101. To establish the MTD of MBRC-101 using 1 or more dosing regimens. To identify potential RP2Ds and regimens of MBRC-101. To evaluate the safety of MBRC-101 at potential OBRDs, RP2Ds, and dosing regimens. To evaluate preliminary clinical activity of MBRC-101.