Evidence map›Paper›PMID 37158938›Full record

ArticleJournal of hematology & oncology2023

First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors.

Yuanyuan Zhao, Yuxiang Ma, Aimin Zang, Ying Cheng, Yiping Zhang, Xiangcai Wang, Zhendong Chen, Song Qu, Jianbo He, Chuanben Chen and 28 more

9 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of hematology & oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 51 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 1 pooled it
10.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04296994 phase1unknown statusnot on this map

A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of QL1706 in Patients With Advanced Malignant Tumor

TypeinterventionalSponsorQilu Pharmaceutical Co., Ltd.Ran2020 to 2023Enrolled99ConditionsAdvanced Malignant TumorArmsQL1706
NCT05171790 phase1unknown statusnot on this map

A Multicenter, Open Phase 1b Study to Evaluate the Efficacy and Safety of QL1706 Injection in Patients With Advanced Malignant Solid Tumors

TypeinterventionalSponsorQilu Pharmaceutical Co., Ltd.Ran2021 to 2023Enrolled419ConditionsAdvanced Solid TumorsArmsQL1706 injection
NCT05179317 phase2unknown statusnot on this map

A Phase II Study of QL1706 Plus Chemotherapy With or Without Bevacizumab for the First-Line Treatment of Recurrent, or Metastatic Cervical Cancer

TypeinterventionalSponsorQilu Pharmaceutical Co., Ltd.Ran2021 to 2023Enrolled60ConditionsCervical CancerArmsQL1706
NCT05446883 phase3unknown statusnot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate QL1706 Plus Paclitaxel-Cisplatin/Carboplatin With or Without Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

TypeinterventionalSponsorQilu Pharmaceutical Co., Ltd.Ran2022 to 2025Enrolled498ConditionsMETASTATIC CERVICAL CANCERArmsQL1706, Placebo, Paclitaxel injection, Cisplatin/Carboplatin
NCT05487391 phase3recruitingnot on this map

QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.

TypeinterventionalSponsorQilu Pharmaceutical Co., Ltd.Ran2022 to 2029Enrolled632ConditionsCarcinoma, Non-Small-Cell LungArmsQL1706 injection, Vinorelbine Tartrate, Paclitaxel, Cisplatin, Carboplatin
NCT05576272 phase2 / phase3unknown statusnot on this map

A Randomized, Open, Multicenter Phase II/III Trial to Compare the Efficacy and Safety of QL1706 and Carrilizumab Combined With Gemcitabine and Cisplatin in First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

TypeinterventionalSponsorQilu Pharmaceutical Co., Ltd.Ran2022 to 2024Enrolled460ConditionsNasopharyngeal CarcinomaArmsQL1706, Carrelizumab, Gemcitabine, Cisplatin
NCT06749899 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1/ CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma:A Randomized, Controlled, Multicenter Phase III Clinical Study.

TypeinterventionalSponsorSun Yat-Sen University Cancer CenterRan2025 to 2030Enrolled580ConditionsNasopharyngeal Cancinoma (NPC), Nasopharyngeal CancerArmsQL1706, Gemcitabine, Cisplatin, Intensity-modulated radiotherapy
NCT07014150 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

An Exploratory Study on the Neoadjuvant Therapy of iIparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma

TypeinterventionalSponsorPeking Union Medical College HospitalRan2025 to 2027Enrolled33ConditionsHepatocellular Carcinoma ResectableArmsLenvatinib, Iparomlimab and Tuvonralimab
NCT07083375 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase II Clinical Trial of Iparomlimab and Tuvonralimab in Combination With Bevacizumab and Platinum-based Chemotherapy in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.

TypeinterventionalSponsorZhijie WangRan2025 to 2027Enrolled56ConditionsExtensive Small Cell Lung CancerArmsQL1706 , bevacizumab, etoposide , cisplatin or carboplatin
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Fc-engineering for improved cancer immunotherapy.Biochemical Society transactions · 2026
    Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Strategies to target PD-1/PD-L1 in the tumor microenvironment.Cellular oncology (Dordrecht, Netherlands) · 2026
    Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

38 authors at 20 institutions in 1 country.

Yuanyuan Zhao *Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, No. 651 Dongfeng East Road, Guangzhou, 510060, China.
Yuxiang Ma *Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, No. 651 Dongfeng East Road, Guangzhou, 510060, China.
Aimin Zang *Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, 071000, China.
Ying Cheng *Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, 130012, China.
Yiping Zhang *The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou, 310022, Zhejiang, China.
Xiangcai Wang *Department of Oncology, First Affiliated Hospital of Gannan Medical University, Ganzhou, 341001, China.
Zhendong Chen *Department of Medical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230093, China.
Song QuDepartment of Radiation Oncology, Guangxi Medical University Cancer Hospital, Cancer Institute of Guangxi, Nanning, 530021, Guangxi, China.
Jianbo HeDepartment of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital, Cancer Institute of Guangxi, Nanning, 530021, Guangxi, China.
Chuanben ChenDepartment of Head and Neck Radiation Oncology, Fujian Cancer Hospital, Fuzhou, 350000, China.
Chuan JinDepartment of Medical Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, 510095, China.
Dongyuan ZhuRare Tumors Department, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.
Qingshan LiDepartment of Oncology, Affiliated Hospital of Chengde Medical University, Chengde, 067000, China.
Xianling LiuDepartment of Oncology, Second Xiangya Hospital, Central South University, Changsha, 410011, China.
Wuyun SuDepartment of Medical Oncology, Affiliated Hospital of Inner Mongolia Medical University, Huhhot, 010050, Inner Mongolia, China.
Yi BaTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, 300060, China.
Yanrong HaoDepartment of Oncology, Clinical Oncology Center, The People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Academy of Medical Sciences, Nanning, 530021, China.
Junmin ChenDepartment of Medical Oncology, Hainan General Hospital, Haikou, 570100, China.
Guoping ZhangDepartment of Medical Oncology, Yuebei People's Hospital, Shaoguan, 512025, China.
Shenhong QuDepartment of Otolaryngology & Head and Neck, The People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Academy of Medical Sciences, Nanning, 530021, China.
Yong LiDepartment of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, 330000, China.
Weineng FengDepartment of Head and Neck/Thoracic Medical Oncology, The First People's Hospital of Foshan, Foshan City, 528010, China.
Mengxiang YangOncology Department, Liaocheng People's Hospital, Liaocheng, 252004, China.
Baorui LiuThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University, Nanjing, 210008, China.
Weiwei OuyangDepartment of Oncology, The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, 550001, China.
Jin LiangDepartment of Oncology, The First Affiliated Hospital of Kunming Medical University, Kunming, 650032, China.
Zhuang YuDepartment of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Xiaoyan KangClinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, 250000, China.
Shilin XueClinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, 250000, China.
Guihong YangDepartment of Clinical Pharmacology, Qilu Pharmaceutical Co., Ltd., Jinan, 250000, China.
Wei YanSound Biologics, 21720 23rd Drive SE, Suite200, Bothell, WA, 98021, USA.
Yingying YangDepartment of Non-Clinical, Qilu Pharmaceutical Co., Ltd., Jinan, 250001, China.
Zhi LiuSound Biologics, 21720 23rd Drive SE, Suite200, Bothell, WA, 98021, USA.
Yufeng PengSound Biologics, 21720 23rd Drive SE, Suite200, Bothell, WA, 98021, USA.
Bill FanslowSound Biologics, 21720 23rd Drive SE, Suite200, Bothell, WA, 98021, USA.
Xian HuangSound Biologics, 21720 23rd Drive SE, Suite200, Bothell, WA, 98021, USA.
Li ZhangDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, No. 651 Dongfeng East Road, Guangzhou, 510060, China. zhangli@sysucc.org.cn.
Hongyun ZhaoDepartment of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, No. 651 Dongfeng East Road, Guangzhou, 510060, China. zhaohy@sysucc.org.cn.
Qilu Hospital of Shandong University · CNSun Yat-sen University · CNGuangxi Medical University · CNGuiyang Medical University · CNThe People's Hospital of Guangxi Zhuang Autonomous Region · CNAffiliated Hospital of Hebei University · CNAffiliated Hospital of Qingdao University · CNAnhui Medical University · CNChengde Medical University · CNFirst Affiliated Hospital of Gannan Medical University · CNFirst Affiliated Hospital of Nanchang University · CNFirst People's Hospital of Foshan · CNFujian Provincial Cancer Hospital · CNGuangzhou Medical University · CNHainan General Hospital · CNInner Mongolia Medical University · CNJilin Province Tumor Hospital · CNKunming Medical University · CNLiaocheng People's Hospital · CNNanjing Drum Tower Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQL1706 (PSB205) is a single bifunctional MabPair (a novel technical platform) product consisting of two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1), with a shorter elimination half-life (t

methodsIn the phase I study, QL1706 was administered intravenously once every 3 weeks at one of five doses ranging from 0.3 to 10 mg/kg, and the maximum tolerated dose, recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of QL1706 were investigated. In the phase Ib study, QL1706 was administered at the RP2D intravenously every 3 weeks, and the preliminary efficacies in non-small cell lung cancer (NSCLC), nasopharyngeal carcinoma (NPC), cervical cancer (CC), and other solid tumors were evaluated.

resultsBetween March 2020 and July 2021, 518 patients with advanced solid tumors were enrolled (phase I, n = 99; phase Ib, n = 419). For all patients, the three most common treatment-related adverse events (TRAEs) were rash (19.7%), hypothyroidism (13.5%), and pruritus (13.3%). The TRAEs and immune-related adverse events (irAEs) of grade ≥ 3 occurred in 16.0% and 8.1% of patients, respectively. In phase I, 2 of 6 patients in the 10mg/kg group experienced dose-limiting toxicities (DLTs) (grade 3 thrombocytopenia and grade 4 immune-mediated nephritis), so the maximum tolerated dose (MTD) was reached at 10 mg/kg. The RP2D was determined to be 5 mg/kg based on comprehensive analysis of tolerability, PK/PD, and efficacy. For all patients who received QL1706 at the RP2D, the objective response rate (ORR) and median duration of response were 16.9% (79/468) and 11.7 months (8.3-not reached [NR]), respectively; and the ORRs were 14.0% (17/121) in NSCLC, 24.5% (27/110) in NPC, 27.3% (15/55) in CC, 7.4% (2/27) in colorectal cancer, 23.1% (6/26) in small cell lung cancer. For immunotherapy-naive patients, QL1706 exhibited promising antitumor activities, especially in NSCLC, NPC, and CC, with ORRs of 24.2%, 38.7%, and 28.3%, respectively.

conclusionsQL1706 was well tolerated and demonstrated promising antitumor activity in solid tumors, especially in NSCLC, NPC, and CC patients. It is currently being evaluated in randomized phase II (NCT05576272, NCT05179317) and phase III (NCT05446883, NCT05487391) trials. Trial Registration ClinicalTrials.gov Identifier: NCT04296994 and NCT05171790.

Indexed as

Antibodies, BispecificAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCTLA-4 AntigenLung NeoplasmsNasopharyngeal CarcinomaUterine Cervical NeoplasmsFemaleHumansImmunoglobulin GAntibodies, BispecificAntineoplastic AgentsCTLA-4 AntigenCTLA4 protein, humanImmunoglobulin GBifunctional PD-1Cervical cancerCTLA4 antibodyMabPairNasopharyngeal carcinomaPhase I trial

Identifiers

PMID37158938
PMCPMC10169367
OpenAlexW4375860868

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

and 3 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.