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Cocktail & Poster Display session

29P - A phase I, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, antitumor activity of QL1604, a humanized anti-PD-1 mAb, in patients with advanced solid tumors


06 Mar 2023


Cocktail & Poster Display session


Yun Fan


Annals of Oncology (2023) 8 (1suppl_2): 100903-100903. 10.1016/esmoop/esmoop100903


Y. Fan1, Y. Xu1, Z. Huang1, W. Hong1, L. Gong2, K. Chen1, J. Qin1, F. Xie1, F. Wang2, X. Tian2, X. Meng2, W. Feng3, L. Li3, B. Zhang3, X. Kang3

Author affiliations

  • 1 Department Of Thoracic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences/ Zhejiang Cancer Hospital, 310022 - Hangzhou/CN
  • 2 Oncology Department, The First Affiliated Hospital of Zhengzhou University, 450052 - Zhengzhou/CN
  • 3 Medcine Department, Qilu Pharmaceutical Co., Ltd., 250104 - Jinan/CN


This content is available to ESMO members and event participants.

Abstract 29P


PD-1 inhibitor has demonstrated promising efficacy in various solid tumors. Here we report the safety, efficacy, ADA, RO and PK/PD results from a phase I study of QL1604, a humanized anti-PD-1 mAb in pts with advanced solid tumors.


Pts with histologically or cytologically confirmed advanced solid tumors, had ≥1 target lesion (RECIST 1.1), and failed standard therapy were enrolled. The study included 2 parts: dose escalation and dose expansion. In the dose-escalation part, a titration design combined with 3+3 method was used. Pts received QL1604 at 0.3mg/kg, 1mg/kg, 3mg/kg, and 10mg/kg dose levels (DLs) Q2W in each 4-week treatment cycle until disease progression or other discontinuation events. The observation period for DLT was 4 weeks after the first dose at each DL. In the dose-expansion part, pts received QL1604 at 3 mg/kg Q2W, 10 mg/kg Q2W, 3 mg/kg Q3W, and 200 mg Q3W DLs. The primary endpoints included MTD, safety, the recommended dose for future clinical studies.


As of 16 Dec 2022, 35 pts were enrolled in 2 sites in China. 18 (51.4%) pts had NSCLC. 32 (91.4%) pts had an ECOG PS of 1. 18 (51.4%) pts previously received ≥3 lines of therapy. 29 (82.9%) pts experienced TRAEs. The most common TRAEs (≥20%) were asthenia (37.1%) and anemia (22.9%). 6 (17.1%) pts experienced Gr ≥3 TRAEs. DLTs were observed in 1 pt (thymic cancer) at 3 mg/kg Q2W DL: Gr 3 immune-mediated myositis and myasthenia gravis. The MTD was not reached. 7 pts had PR (1 to 10 mg/kg Q2W or Q3W and 200 mg/kg Q3W; 5 pts with NSCLC and 2 pts with nasopharyngeal carcinoma). The ORR was 20% (7/35) and DCR was 34.3% (12/35). The AUC and Cmax increased in an approximately dose-proportional manner in the dose range 0.3 mg/kg to 10 mg/kg. 3 pts tested ADA positive at baseline and 16 pts had at least one positive result after dosing. RO was >80% on day 15 and day 22 at 3 mg/kg Q2W, 3 mg/kg Q3W, and 200 mg Q3W DLs.


QL 1604 showed good safety profile and efficacy signal in the dose range of 0.3 to 10 mg/kg (Q2W or Q3W) and at a fixed dose of 200 mg Q3W for pts with advanced solid tumors. 3 mg/kg Q3W and 200 mg Q3W were chosen as the recommended doses for future clinical studies.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Qilu Pharmaceutical Co., Ltd.


Qilu Pharmaceutical Co., Ltd.


W. Feng, L. Li, B. Zhang, B. Zhang: Other, Personal, Full or part-time Employment: Qilu Pharmaceutical Co., Ltd. All other authors have declared no conflicts of interest.

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