Abstract
TPS3147 Background: CD40 is a key costimulatory molecule for both the innate and adaptive immune systems that is essential for T-cell activation and proliferation. OX40 is a costimulatory molecule that is involved in enhancing nascent immune responses and concomitantly acts to suppress regulatory T-cell activity. ABBV-927 and ABBV-368 are potent agonistic antibodies against CD40 and OX40, respectively. This open-label, Phase 1 study will evaluate the doublet combination of ABBV-927 and ABBV-368 and the triplet combination of ABBV-927, ABBV-368, and the programmed cell death protein-1 (PD-1) inhibitor budigalimab in patients with advanced solid tumors. Methods: For this study (NCT03893955), patients must be ≥18 y with an Eastern Cooperative Oncology Group performance status of 0-1. Patients must have an advanced solid tumor that has progressed on standard therapies. Disease-specific cohorts will include patients with non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). Patients with NSCLC must have previously received a PD-1/PD-ligand 1 inhibitor and a platinum-based therapy and no more than one prior immunotherapy. Patients with TNBC must not have received immunotherapy. Patients with uncontrolled central nervous system metastases will be excluded. The recommended Phase 2 dose (RP2D) will first be identified with ABBV-927 + ABBV-368 in patients with solid tumors (Arm A) and will be expanded in disease-specific cohorts including TNBC. The RP2D of ABBV-927 + ABBV-368 + budigalimab will be identified in patients with NSCLC (Arm B). The primary endpoints are determination of the RP2D of ABBV-927 + ABBV-368, the RP2D of ABBV-927 + ABBV-368 + budigalimab, and overall response rate; duration of response, progression-free survival, safety, and pharmacokinetics are secondary endpoints. Screening began on 21 May 2019, and enrollment is ongoing. Clinical trial information: NCT03893955 .
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