Phase 1 Soon Recruiting: MK-2400 (Ifinatamab Deruxtecan) for Metastatic Prostate Cancer

MK-2400or Ifinatamab Deruxtecan (I-DXd), an investigational antibody-drug conjugate (ADC) targeting TROP2, continues to advance in clinical development, demonstrating notable activity in early trials and expanding its evaluation into new tumor types. This therapeutic approach leverages an antibody designed to seek out TROP2, a protein overexpressed on the surface of various solid tumors, and deliver a potent cytotoxic payload directly to the cancer cells.
The rationale for targeting TROP2 stems from its association with tumor growth and poorer prognosis across multiple cancers. By binding specifically to TROP2-expressing cells, ADCs like MK-2400 aim to maximize the anti-cancer effect within the tumor while potentially minimizing systemic toxicity compared to traditional chemotherapy.
Encouraging preliminary results have emerged from studies involving patients with non-small cell lung cancer (NSCLC), often a challenging malignancy to treat, particularly in later stages.

In an interim analysis presented from an early-phase trial involving pre-treated NSCLC patients, MK-2400 demonstrated significant anti-tumor activity. The objective response rate (ORR) reached 52.4%, indicating that over half the patients experienced meaningful tumor shrinkage. This included a complete response (CR) rate of 4.8%, where patients showed no detectable signs of cancer, and a partial response (PR) rate of 47.6%, reflecting substantial tumor reduction.

Building on these findings and the knowledge that TROP2 is also expressed in prostate cancer, particularly in advanced stages like metastatic castration-resistant prostate cancer (mCRPC), the clinical development program for MK-2400 is expanding. A Phase 1 clinical trial focused specifically on patients with mCRPC is reported to be enrolling soon (est. June 2025).

This upcoming Phase 1 study in mCRPC will primarily focus on establishing the safety, tolerability, and identifying the recommended dose of MK-2400 within this specific patient population.

Clinical trial.