Drugs / Pucotenlimab
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Pucotenlimab

also known as HX008 · Puco

Monoclonal antibody targets PDCD1 via inhibition

Developed for
head and neck squamous cell carcinoma · melanoma · gastric cancer · hepatocellular carcinoma · intrahepatic cholangiocarcinoma · nasopharyngeal carcinoma · penile cancer · cancer
+32 more · childhood malignant neoplasm · colorectal cancer · gastroesophageal junction adenocarcinoma · neoplasm · non-small cell lung carcinoma · rectal cancer · triple-negative breast carcinoma · biliary tract cancer · cancer of unknown primary site · carcinoma · cholangiocarcinoma · clear cell renal carcinoma · digestive system cancer · gastroesophageal adenocarcinoma · head and neck cancer · hepatoblastoma · hereditary nonpolyposis colon cancer · hypopharynx squamous cell carcinoma · lymphoepithelial-like carcinoma · malignant pancreatic neoplasm · metastatic melanoma · mucosal melanoma · neuroendocrine neoplasm · rectum adenocarcinoma · refractory malignant neoplasm · renal cell carcinoma · rhabdomyosarcoma · salivary gland carcinoma · skin squamous cell carcinoma · thyroid cancer · thyroid gland undifferentiated (anaplastic) carcinoma · urinary bladder cancer
Investigated by
Taizhou Hanzhong Biomedical Co., Ltd. · Sun Yat-sen University · Fudan University · Lepu Biopharma Co., Ltd. · Shanghai Miracogen Inc. · Sir Run Run Shaw Hospital
+34 more · Lepu Medical Technology (Beijing) Co., Ltd. · Binhui Biopharmaceutical Co., Ltd. · Jiyan Liu · Peking University Cancer Hospital & Institute · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai Zhongshan Hospital · Tongji Hospital · West China Hospital · Affiliated Cancer Hospital of Shantou University Medical College · Anhui Provincial Cancer Hospital · Biotech Pharmaceutical Co., Ltd. · Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center · Chinese Cooperative Group of Liver Cancer · Fujian Medical University · Fujian Province Tumor Hospital · Geneplus-Beijing Co. Ltd. · Groupe Oncologie Radiotherapie Tete et Cou · HuiKai Li · Ji Dongmei · Jiangsu Cancer Institute & Hospital · Lei Liu · Ming-Yuan Chen · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai GoBroad Cancer Hospital · Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine · Taizhou HoudeAoke Biomedical Co., Ltd. · Tang-Du Hospital · The University of Hong Kong-Shenzhen Hospital · Tianjin Medical University Cancer Institute and Hospital · Tianjin Medical University Second Hospital · Wang Xin · West China Second University Hospital · Zhejiang Provincial People's Hospital · Zhiguo Luo, MD, PhD

Trials 66 · started per year

today
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201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07356466 May 2025 → Apr 2027 expected gastric cancer Fujian Medical University Enrolling by invitation No outcome recorded
Phase 15 trials
Phase 1 NCT07054307 Feb → Jul 2026 overdue penile cancer Jiyan Liu Recruiting No outcome recorded
Phase 1 NCT05070221 Oct 2021 → Oct 2023 melanoma Peking University Cancer Hospital & Institute Unknown No outcome recorded
Phase 1 NCT05068453 Oct 2021 → Oct 2023 metastatic melanoma Peking University Cancer Hospital & Institute Unknown No outcome recorded
Phase 1 NCT04756934 Aug 2020 → Aug 2021 melanoma Taizhou HoudeAoke Biomedical Co., Ltd. Unknown No outcome recorded
Phase 1 NCT04825392 Sep 2019 → May 2021 neoplasm Taizhou Hanzhong Biomedical Co., Ltd. Unknown No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT07479485 Apr 2026 → Apr 2028 expected hepatocellular carcinoma Lepu Biopharma Co., Ltd. Not yet recruiting No outcome recorded
Phase 1/2 NCT07312422 Sep 2025 → Apr 2026 overdue malignant pancreatic neoplasm Zhejiang Provincial People's Hospital Recruiting No outcome recorded
Phase 1/2 NCT06456892 Jun 2024 → Jun 2026 overdue childhood malignant neoplasm, rhabdomyosarcoma Sun Yat-sen University Recruiting No outcome recorded
Phase 1/2 NCT05338957 Aug 2022 → Jun 2024 cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 1/2 NCT05688605 Jun 2022 → May 2025 cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 1/2 NCT04616443 Dec 2020 → Nov 2025 overdue melanoma Binhui Biopharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT04750382 Jul 2019 → Dec 2020 triple-negative breast carcinoma Taizhou Hanzhong Biomedical Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03866525 Apr 2019 → Aug 2025 overdue digestive system cancer Binhui Biopharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 243 trials
Phase 2 NCT07707167 Aug 2026 → Jan 2028 expected head and neck squamous cell carcinoma Jiangsu Cancer Institute & Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07712029 Aug 2026 → Aug 2028 expected refractory malignant neoplasm Tianjin Medical University Second Hospital Recruiting No outcome recorded
Phase 2 NCT07518979 Jul 2026 → May 2028 expected penile cancer Jiyan Liu Not yet recruiting No outcome recorded
Phase 2 NCT07692334 Jul 2026 → Sep 2027 expected gastric cancer, gastroesophageal junction adenocarcinoma West China Second University Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07627321 Jul 2026 → Jul 2028 expected non-small cell lung carcinoma Anhui Provincial Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07665190 Jul 2026 → Oct 2027 expected hypopharynx squamous cell carcinoma Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded
Phase 2 NCT07649980 Jul 2026 → Jul 2029 expected biliary tract cancer HuiKai Li Not yet recruiting No outcome recorded
Phase 2 NCT07632339 Jun 2026 → Jun 2028 expected head and neck cancer Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Recruiting No outcome recorded
Phase 2 NCT07651007 May 2026 → Dec 2027 expected rectal cancer Wang Xin Not yet recruiting No outcome recorded
Phase 2 NCT07628855 May 2026 → Aug 2028 expected hereditary nonpolyposis colon cancer Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center Not yet recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04750083 Sep 2020 → Sep 2022 non-small cell lung carcinoma Taizhou Hanzhong Biomedical Co., Ltd. Unknown No outcome recorded
Phase 36 trials
Phase 3 NCT07524413 Apr 2026 → Apr 2030 expected nasopharyngeal carcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 3 NCT07524452 Feb 2026 → Feb 2031 expected head and neck squamous cell carcinoma Ming-Yuan Chen Recruiting No outcome recorded
Phase 3 NCT06976190 May 2025 → May 2029 expected nasopharyngeal carcinoma Shanghai Miracogen Inc. Recruiting No outcome recorded
Phase 3 NCT05652894 Feb 2023 → Jun 2026 overdue colorectal cancer Taizhou Hanzhong Biomedical Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT05647954 Dec 2022 → Dec 2024 neuroendocrine neoplasm Taizhou Hanzhong Biomedical Co., Ltd. Unknown No outcome recorded
Phase 3 NCT04486651 Sep 2020 → Aug 2023 gastric cancer Taizhou Hanzhong Biomedical Co., Ltd. Unknown No outcome recorded
Phase not applicable2 trials
NCT07092449 Aug 2025 → Dec 2027 expected gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma Tang-Du Hospital Not yet recruiting No outcome recorded
NCT07188311 Apr 2025 → Apr 2027 expected childhood malignant neoplasm, hepatoblastoma Sun Yat-sen University Recruiting No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT07586124 Background Jul 2026 → Dec 2027 expected head and neck squamous cell carcinoma Lepu Biopharma Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT07448142 Background Mar 2026 → Sep 2027 expected colorectal cancer Sun Yat-sen University Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07598318 Background May 2026 → Dec 2027 expected cholangiocarcinoma Sir Run Run Shaw Hospital Not yet recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT07528209 Comparator Apr 2026 → Apr 2032 expected rectal cancer Sun Yat-sen University Recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 72 sources stand behind the page.

FieldValueCited text
Known as Pucotenlimab “CONCLUSIONS: Pucotenlimab as a ≥ 2nd line therapy showed promising efficacy and tolerable toxicity for patients with locally advanced or metastatic melanoma. TRIAL...” PMID 36747118 Feb 2023
51

“We report a multicenter, phase 2 study evaluating the efficacy of pucotenlimab, an anti-PD-1 antibody, in patients with mismatch repair-deficient (dMMR) or microsatellite...” PMID 38016482 Nov 2023

“Neoadjuvant immunotherapy with pucotenlimab (200mg, Day 1, Q3W, 2 cycles); Adjuvant immunotherapy duiring and after radiotherapy with pucotenlimab (200mg, Day 1, Q3W, for a...” NCT07524452

“Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1” NCT06889610

“short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy” NCT07651007

Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin)” NCT07092449

“2. pucotenlimab: 200mg, intravenous, every 3 weeks, on day 1” NCT07514533

“[Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg]” NCT07354984

“MRG006A+Pucotenlimab + Bevacizumab” NCT07479485

“Drug: HX008(Pucotenlimab)” NCT05652894

NCT07707167

NCT06530914

NCT06192797

NCT07528209

NCT07501104

NCT06969534

NCT06976190

NCT06872606

NCT07497919

NCT07545083

NCT06524466

NCT06869174

NCT06895369

NCT07692334

NCT07586124

NCT07649980

NCT06192784

NCT07381699

NCT06770270

NCT07235566

NCT07353827

NCT07464366

NCT06129955

NCT07627321

NCT07524413

NCT07386158

NCT07665190

NCT07393477

NCT07188311

NCT07632339

NCT07598318

NCT07712029

NCT06456892

NCT07394244

NCT07628855

NCT07448142

NCT07356466

NCT07589049

NCT06959108

NCT07312422

NCT07518979

NCT07353073

Known as HX008 “Patients histologically confirmed mucosal melanoma will get OH2 (once every two weeks)and HX-008 (once every three weeks)and Axitinib (once every day).” NCT05070221
22

“Pucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg/kg (maximum 200 mg), once every 3 weeks on Day 1 (D1).” NCT07627321

“Pucotenlimab (HX008) is a PD-1 inhibitor with an extended half-life (T1/2 = 21.76 days).” NCT07589049

“HX-008:200mg/time,Q3W,i.v.;” NCT05068453

“Pucotenlimab(HX008)” NCT07665190

NCT04738630

NCT05652894

NCT04756934

NCT04574817

NCT04741165

NCT04486651

NCT07054307

NCT04749485

NCT04508803

NCT04750083

NCT04616443

NCT05688605

NCT04750382

NCT03866525

NCT04868162

NCT05647954

NCT05338957

NCT04825392

Known as Puco “After enrollment, patients will immediately begin treatment with Lenvatinib (Len) and Pucotenlimab (Puco).” NCT06524466
Action Inhibit “PD-1 blockade monotherapy” NCT03704246
Modality Monoclonal antibody “Anti-PD-1 Monoclonal AntibodyNCT04486651
Route Intravenous “200 mg administered as IV infusion” NCT04486651
Target PDCD1 “pucotenlimab, an anti-PD-1 antibody” PMID 38016482 Nov 2023