Phase 1 Trial for DR-0202 Bispecific Antibody for Solid Tumors

The renewed focus on immune therapy for solid tumors by pharmaceutical companies is advancing DR-0202, a groundbreaking first-in-class bispecific antibody designed to fundamentally change how we treat a wide array of advanced solid tumors, including metastatic castration-resistant prostate cancer (mCRPC). This innovative therapeutic doesn’t directly attack cancer cells; instead, it leverages the body’s own immune system, specifically, myeloid cells, to seek out and destroy malignancies.

DR-0202 operates through a sophisticated dual-action mechanism. It’s engineered to bind simultaneously to a unique phagocytic receptor called CLEC7A (also known as Dectin-1) found on myeloid cells, and to a specific, yet undisclosed, receptor “highly expressed in various solid tumors”. This dual binding acts as a molecular bridge, bringing these powerful immune cells directly to the cancer. Once engaged, the myeloid cells are activated to engulf and eliminate the tumor cells through a process called phagocytosis.

But DR-0202’s impact extends beyond this immediate destruction. A crucial aspect of its design is its ability to “cross-present antigens” from the consumed cancer cells to the adaptive immune system. This process effectively “primes the adaptive immune system,” teaching the body’s T cells to recognize and remember the tumor’s unique markers. The ultimate goal is to generate “deep and durable responses” , fostering long-lasting immunity that could prevent cancer recurrence. This indirect activation strategy is particularly promising for solid tumors, which often create challenging environments that can hinder more direct T-cell therapies.

The potential of DR-0202 is currently being explored in a Phase 1a/1b clinical trial (NCT06999187), which is actively recruiting patients across the United States. This comprehensive study targets a broad spectrum of locally advanced or metastatic, relapsed or refractory carcinomas, including notoriously difficult-to-treat cancers such as castration-resistant prostate cancer, pancreatic ductal adenocarcinoma, and non-small cell lung cancer.

A key differentiator for DR-0202 is its potential for a superior safety profile. The antibody is meticulously designed to ensure “controlled myeloid cell activation only in the presence of the target antigen”. This built-in specificity aims to prevent the widespread, non-specific immune activation that can lead to severe side effects like Cytokine Release Syndrome (CRS) and neurotoxicity, which have been observed with some other immunotherapies.

Clinical trial.

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