AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors

• DOI: 10.1136/jitc-2022-005829
• Publication Date: 2023-10-20T00:50:36Z
• Authors: Sophia Frentzas; Steven Kao; Rang Gao; Hao Zheng; Ahsan Rizwan; Nageshwar Budha; Luz de la Hoz Ped...; Wei Tan; Tarek Meniawy
• Keywords: Discontinuation; TIGIT; Chills

Background Ociperlimab, a novel, humanized monoclonal antibody (mAb), binds to T-cell immunoreceptor with immunoglobulin and tyrosine-based inhibitory motif domains (TIGIT) high affinity specificity. Tislelizumab is an anti-programmed cell death protein 1 mAb. We report results from phase I, first-in-human, dose escalation study evaluating the safety, pharmacokinetics (PK), preliminary antitumor activity of ociperlimab plus tislelizumab in patients advanced solid tumors. Methods Eligible previously treated standard systemic therapy, or for whom treatment was not available tolerated, received intravenously on Cycle (C) Day (D) 200 mg C1 D8. If sequentially D29 every 3 weeks (Q3W) thereafter until discontinuation. Dose planned four levels (50 mg, 150 450 900 mg) according 3+3 design. An additional level 1800 also assessed. Primary endpoints were determination maximum tolerated (or administered) dose, recommended II (RP2D). Secondary included overall response rate (ORR), duration (DoR), disease control (DCR) (Response Evaluation Criteria Solid Tumors version 1.1), PK, biomarker analysis. Results At data cut-off (September 29, 2022), 32 had ≥1 Q3W. The administered median age enrolled 59.5 years (range: 31–79). Most (96.9%) experienced treatment-emergent adverse event (TEAE); 62.5% ≥grade TEAEs 50.0% serious TEAEs. No limiting toxicity events reported. reached. RP2D Overall, ORR 10.0%, DoR 3.6 months, DCR 50.0%. Conclusions Ociperlimab well tumors, observed ociperlimab. Phase II/III trials Q3W are underway range Trial registration number NCT04047862 .