On 14 Apr 2023, the first-in-class first-in-human phase 1 trial and translational study of the mono (ADP-ribose) polymerase-7 (PARP7) inhibitor RBN-2397 was reported at the AACR Congress.
RBN-2397 is a small molecule drug that falls under the therapeutic area of neoplasms and respiratory diseases. It specifically targets PARP-7, a protein involved in DNA repair processes. The drug is being developed to treat various types of cancers, including squamous cell lung carcinoma, squamous non-small cell lung cancer, and solid tumors.
According to the Patsnap Synapse, RBN-2397 has reached the highest phase of clinical trials, which is Phase 1/2. And the clinical trial areas for RBN-2397 are primarily in the United States, United Kingdom, and Israel. The key indication is Small Cell Lung Cancer.
The single group assignment, open-labeled clinical trial (NCT05127590) was conducted in patients with selected advanced solid tumors.
In this study, pts with solid tumors were treated with RBN-2397 at the RP2D of 200 mg BID in 3 expansion cohorts: squamous cell carcinoma of the lung (SCCL), head and neck squamous cell carcinoma (HNSCC), and hormone receptor-positive breast cancer (HR+ BC). Objectives of the expansion phase included safety, pharmacokinetics, pharmacodynamics, and antitumor activity.
The result showed that as of 2 July 2022, 31 pts have been treated: SCCL (n=13), HNSCC (n=10), and HR+ BC (n=8). RBN-2397-related AEs (all grades >10%) included dysgeusia (42%, n=13), nausea (26%, n=8), fatigue (23%, n=7), with Grade 3 events of nausea and pleural infection (each n=1) and ALT/AST increase (n=2), and no Grade 4 events. No significant chronic toxicities were observed. The disease control rate in response-evaluable pts was 44% in SCCL (stable disease [SD] in 4/9 pts), 71% in HNSCC (RECIST partial response [PR] for 12+ months in 1/7; SD in 4/7), and 29% in HR+ BC (SD in 2/7). Analyses of paired tumor biopsies confirmed induction of adaptive immunity with ≥2-fold increases in CD8+ T cells and/or granzyme B expression in 10 (63%) of 16 pts across tumor types. Increases in immune checkpoint expression (PD-1 and LAG3 on T cells; PD-L1 on tumor cells) from 30% to 150% were observed in 3 (60%) of 5 pt tumor samples evaluated using MIBI-SCOPE, indicating the potential to prime tumors for immune checkpoint inhibitor therapy.
It can be concluded that RBN-2397 was well tolerated at biologically active drug exposures, with preliminary antitumor activity observed. Paired tumor biopsy translational studies demonstrated the immunomodulatory mechanism of RBN-2397 and support the ongoing trial of RBN-2397 in combination with pembrolizumab (NCT05127590).
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