New targeted cancer therapy IDE034 heading to Phase 1 clinical trial
Study expected to begin in first quarter 2026 for patients with solid tumors
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A Phase 1 clinical trial testing the experimental therapy IDE034 in people with various types of cancer, including gynecological cancers, is expected to start in the first quarter of 2026.
The trial is being conducted by Ideaya Biosciences, which is developing IDE034 under a licensing agreement reached in July 2024 with Biocytogen Pharmaceuticals, which independently developed the therapy. The U.S. Food and Drug Administration (FDA) recently cleared an investigational new drug application (IND) from Ideaya, allowing the trial to move forward.
“The IND clearance for IDE034 is an important milestone in the development of this [IDE034], representing a significant advancement for Ideaya in expanding its clinical pipeline with bispecific, precision-targeted strategies,” Yuelei Shen, Chairman and CEO of Biocytogen, said in a company press release.
Lab findings point to potential across several tumor types
According to Biocytogen, the upcoming trial is expected to start enrollment in the first quarter of 2026. The study will test IDE034 in people with solid tumors that express two proteins, B7H3 and PTK7. In addition to ovarian and other forms of gynecological cancer, the trial will also be open to people with lung, colorectal, and head and neck cancers. Biocytogen did not provide details about the study’s design or goals.
“We look forward to seeing IDE034 demonstrate clinical potential across multiple B7H3/PTK7 co-expressing solid tumors, offering new therapeutic options for patients,” Shen said.
The proteins B7H3 and PTK7 are expressed together on a substantial subset of solid tumors. IDE034 is an antibody-drug conjugate, designed to bind to both of these proteins and deliver a TOP1 (topoisomerase I) cell-killing drug to targeted cancer cells. The goal is to direct the treatment toward tumors that express B7H3 and PTK7, which may help limit effects on cells that do not carry these proteins.
According to Biocytogen, lab experiments with IDE034 have shown that the treatment led to “deep and durable tumor regressions in multiple B7H3/PTK7-positive tumor models, demonstrating strong anti-tumor activity.” Those experiments tested IDE034 as a single treatment, but Ideaya also plans to study the therapy in combination with another of its experimental treatments, IDE161, to enhance the durability of response, according to Biocytogen.
