This is a first-in-human, open-label, Phase 1/2 study in patients with advanced metastatic solid tumors refractory to standard treatment, including metastatic castration-resistant prostate cancer (mCRPC), breast cancer, colorectal cancer (CRC), pancreatic cancer, and non-small cell lung cancer (NSCLC).

Phase 1 will identify potential optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of MBRC-201 at one or more dosing regimens.

Phase 1b will evaluate the safety and preliminary activity of MBRC-201 at clinically relevant doses in mCRPC, breast cancer, NSCLC and other solid tumors. Phase 1 and Phase 1b will characterize single and multiple-dose pharmacokinetics profiles of MBRC-201.

The initial Phase 2 will further evaluate antitumor activity and safety of MBRC-201 at the RP2D determined during Phase 1b. Phase 2 will enroll patients in tumor-specific cohorts from the indications evaluated in Phase 1a/1b.

For more information about the MBRC-201-001 clinical trial, and to review patient eligibility criteria, visit clinicaltrials.gov (identifier NCT07145255).