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Drugs / Cadonilimab
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Cadonilimab

also known as AK104 · Cadonilimab (AK104) · Candonilimab · cardonilizumab · cardonirimab

Monoclonal antibody targets CTLA4 via inhibition

Developed for
hepatocellular carcinoma · non-small cell lung carcinoma · colorectal cancer · cervical cancer · esophageal squamous cell carcinoma · gastric cancer · gastroesophageal junction adenocarcinoma · nasopharyngeal carcinoma
+60 more · cancer · gastric adenocarcinoma · gastroesophageal adenocarcinoma · small cell lung carcinoma · cervical carcinoma · melanoma · ovarian cancer · peritoneal carcinomatosis · biliary tract cancer · head and neck squamous cell carcinoma · pancreatic ductal adenocarcinoma · triple-negative breast carcinoma · bile duct adenocarcinoma · clear cell renal carcinoma · endometrium adenocarcinoma · gastroesophageal cancer · intrahepatic cholangiocarcinoma · malignant pancreatic neoplasm · metastatic malignant neoplasm in the brain · renal cell carcinoma · soft tissue sarcoma · urinary bladder cancer · adenocarcinoma · breast cancer · cancer of unknown primary site · carcinoma of esophagus · cholangiocarcinoma · colorectal adenocarcinoma · combined hepatocellular carcinoma and cholangiocarcinoma · cutaneous melanoma · endocervical adenocarcinoma · endometrial carcinoma · esophageal cancer · glioblastoma · infiltrating bladder urothelial carcinoma · intestinal cancer · lung cancer · malignant pleural mesothelioma · metastasis from malignant tumor of colon · metastatic carcinoma · metastatic melanoma · mismatch repair cancer syndrome · mismatch repair cancer syndrome 3 · mucosal melanoma · neoplasm · neoplastic meningitis · ovarian carcinoma · pancreatic adenocarcinoma · pancreatic neoplasm · peripheral T-cell lymphoma, not otherwise specified · pleural mesothelioma · portal vein thrombosis · rectal cancer · rectal carcinoma · salivary gland carcinoma · sarcomatoid renal cell carcinoma · urinary system neoplasm · urothelial carcinoma · uterine cancer · vulva cancer
Investigated by
Akeso · Akeso Pharmaceuticals, Inc. · Sun Yat-sen University · Fudan University · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Tianjin Medical University Cancer Institute and Hospital
+125 more · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Fujian Cancer Hospital · Akesobio · Hunan Cancer Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Tongji Hospital · Zhejiang Cancer Hospital · Akeso Biopharma, Inc. · Guangzhou Institute of Respiratory Disease · Henan Cancer Hospital · Ruijin Hospital · Shanghai Pulmonary Hospital, Shanghai, China · Shanghai Zhongshan Hospital · Sichuan University · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · The First Affiliated Hospital of Zhengzhou University · West China Hospital · Anhui Provincial Hospital · Eastern Hepatobiliary Surgery Hospital · First Affiliated Hospital of Guangxi Medical University · Guangxi Medical University · Harbin Medical University · Hubei Cancer Hospital · Nanfang Hospital, Southern Medical University · Shanxi Province Cancer Hospital · Shengjing Hospital · Sichuan Cancer Hospital and Research Institute · University of Texas Southwestern Medical Center · West China Second University Hospital · Women's Hospital School Of Medicine Zhejiang University · Xiangya Hospital of Central South University · Xijing Hospital · Affiliated Hospital of North Sichuan Medical College · Akeso Biopharma Co., Ltd. · Beijing Friendship Hospital · Caigang Liu · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · China Medical University, China · Chinese Academy of Medical Sciences · Chinese PLA General Hospital · Chipscreen Biosciences, Ltd. · Chongqing University Cancer Hospital · Fei Gao · First Affiliated Hospital of Ningbo University · Fujian Provincial Hospital · Gansu Provincial Maternal and Child Health Care Hospital · Guangzhou Medical University · Guangzhou University of Traditional Chinese Medicine · Guizhou Provincial People's Hospital · Guizhou Tongren People's Hospital · Hao Zeng · Haplox Biotechnology Co., Ltd. · Hebei Medical University Fourth Hospital · Henan Provincial People's Hospital · Huazhong University of Science and Technology · JIN JING · Jinshan Hospital Fudan University · Josephine Hughes Sterling Foundation · Lei Liu · Liaoning Cancer Hospital & Institute · Liu Huang · LiuYing · M.D. Anderson Cancer Center · Maia Biotechnology · Memorial Sloan Kettering Cancer Center · Meng Chao Hepatobiliary Hospital of Fujian Medical University · National Cancer Institute (NCI) · Obstetrics & Gynecology Hospital of Fudan University · Peking Union Medical College · Peking Union Medical College Hospital · Peking University · Peking University Cancer Hospital & Institute · Peking University Hospital of Stomatology · Peking University People's Hospital · all 131 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed China (NMPA) — recurrent or metastatic cervical cancer 2021-09-24

“开坦尼单抗（Cadonilimab，研发代号：AK104）用于治疗复发或转移性宫颈癌的上市申请，并获优先审评” akesobio.com ↗

Trials 208 · started per year

today
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20182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT07446257 Sep 2026 → Sep 2029 expected hepatocellular carcinoma University of Texas Southwestern Medical Center Recruiting No outcome recorded
Phase 0 NCT07586904 May 2025 → Dec 2026 expected cutaneous melanoma Xijing Hospital Recruiting No outcome recorded
Phase 112 trials
Phase 1 NCT07619001 Jun → Sep 2026 overdue — Akeso Not yet recruiting No outcome recorded
Phase 1 NCT06913218 Jul 2025 → Feb 2028 expected pancreatic ductal adenocarcinoma Akeso Not yet recruiting No outcome recorded
Phase 1 NCT07359235 Nov 2024 → Dec 2028 expected urinary bladder cancer Tongji Hospital Recruiting No outcome recorded
Phase 1 NCT05856864 Jun → Jul 2024 hepatocellular carcinoma Tianjin Medical University Cancer Institute and Hospital Unknown No outcome recorded
Phase 1 NCT06424626 May 2024 → Dec 2027 expected metastatic melanoma, mucosal melanoma Peking University Cancer Hospital & Institute Enrolling by invitation No outcome recorded
Phase 1 NCT05868876 Jun 2023 → Nov 2025 overdue cancer Akeso Recruiting No outcome recorded
Phase 1 NCT05737368 Feb 2023 → Feb 2024 glioblastoma Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
Phase 1 NCT05644392 Nov 2022 → Nov 2025 — Tianjin Medical University Cancer Institute and Hospital Unknown No outcome recorded
Phase 1 NCT05644379 Nov 2022 → Nov 2025 overdue — Tianjin Medical University Cancer Institute and Hospital Active not recruiting No outcome recorded
Phase 1 NCT04572152 Dec 2020 → May 2023 — Akeso Completed No outcome recorded
Phase 1/228 trials · 1 missed
Phase 1/2 NCT06940921 Mar 2025 → Nov 2027 expected colorectal cancer, gastric cancer, ovarian cancer, peritoneal carcinomatosis Zhang Tao Active not recruiting No outcome recorded
Phase 1/2 NCT06762080 Mar 2025 → Sep 2026 overdue neoplastic meningitis Guangzhou Medical University Active not recruiting No outcome recorded
Phase 1/2 NCT06646055 Jan 2025 → Dec 2026 expected pancreatic ductal adenocarcinoma Akeso Active not recruiting No outcome recorded
Phase 1/2 NCT06530251 Sep 2024 → Jun 2026 overdue hepatocellular carcinoma Akeso Recruiting No outcome recorded
Phase 1/2 NCT06586294 Sep 2024 → Jul 2026 overdue gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Akeso Not yet recruiting No outcome recorded
Phase 1/2 NCT06577961 Aug 2024 → Aug 2027 expected renal cell carcinoma Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 1/2 NCT06650332 Jul 2024 → Aug 2026 overdue gastroesophageal cancer Zhejiang Cancer Hospital Recruiting No outcome recorded
Phase 1/2 NCT06477523 May 2024 → Dec 2026 expected small cell lung carcinoma Sichuan University Active not recruiting No outcome recorded
Phase 1/2 NCT05808608 Nov 2023 → Apr 2026 overdue sarcomatoid renal cell carcinoma Hao Zeng Active not recruiting No outcome recorded
Phase 1/2 NCT05944224 Oct 2023 → May 2026 overdue cancer Shanghai Pharmaceuticals Holding Co., Ltd Recruiting No outcome recorded
Phase 2138 trials
Phase 2 NCT07635290 Jun 2026 → Jun 2027 expected biliary tract cancer West China Hospital Active not recruiting No outcome recorded
Phase 2 NCT07631000 May 2026 → May 2029 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT06889610 Mar 2026 → Dec 2027 expected colorectal cancer, melanoma, triple-negative breast carcinoma Fudan University Recruiting No outcome recorded
Phase 2 NCT07450963 Mar 2026 → Feb 2029 expected cervical cancer Ruijin Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07263919 Dec 2025 → Mar 2030 expected esophageal squamous cell carcinoma Akeso Recruiting No outcome recorded
Phase 2 NCT07243951 Nov 2025 → Dec 2026 expected combined hepatocellular carcinoma and cholangiocarcinoma Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07544784 Nov 2025 → Dec 2027 expected metastasis from malignant tumor of colon Fudan University Recruiting No outcome recorded
Phase 2 NCT07245446 Oct 2025 → Dec 2027 expected small cell lung carcinoma Akeso Recruiting No outcome recorded
Phase 2 NCT07052253 Jul 2025 → May 2027 expected hepatocellular carcinoma Akeso Recruiting No outcome recorded
Phase 2 NCT06984718 Jun 2025 → Nov 2026 expected hepatocellular carcinoma Akeso Not yet recruiting No outcome recorded
Show all 138 trials opens the full record — a long page
Phase 2/32 trials
Phase 2/3 NCT06221748 Feb 2024 → Dec 2026 expected gastric cancer, gastroesophageal junction adenocarcinoma RemeGen Co., Ltd. Recruiting No outcome recorded
Phase 2/3 NCT06241599 Feb 2024 → Feb 2026 overdue nasopharyngeal carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 319 trials · 2 met primary
Phase 3 NCT07700979 Sep 2026 → Aug 2029 expected gastroesophageal adenocarcinoma Akeso Recruiting No outcome recorded
Phase 3 NCT07815834 Sep 2026 → Aug 2030 expected colorectal adenocarcinoma, peritoneal carcinomatosis Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT07400536 Apr 2026 → Jul 2028 expected cervical carcinoma Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Phase 3 NCT07412613 Apr 2026 → Jun 2030 expected colorectal cancer Akeso Recruiting No outcome recorded
Phase 3 NCT07449780 Mar 2026 → Nov 2027 expected gastroesophageal adenocarcinoma Akeso Not yet recruiting No outcome recorded
Phase 3 NCT07023315 Aug 2025 → Jul 2029 expected gastroesophageal adenocarcinoma Akeso Recruiting No outcome recorded
Phase 3 NCT06949033 May 2025 → Dec 2028 expected gastroesophageal cancer Zuoyi Jiao Recruiting No outcome recorded
Phase 3 NCT06617416 Nov 2024 → Oct 2026 expected non-small cell lung carcinoma Akeso Recruiting No outcome recorded
Phase 3 NCT06664983 Oct 2024 → Oct 2025 overdue nasopharyngeal carcinoma Sun Yat-sen University Active not recruiting No outcome recorded
Phase 3 NCT06542549 Oct 2024 → Oct 2027 expected ovarian carcinoma Anhui Provincial Hospital Not yet recruiting No outcome recorded
Phase not applicable7 trials
— NCT06878196 Mar 2025 → Dec 2028 expected cervical cancer Obstetrics & Gynecology Hospital of Fudan University Not yet recruiting No outcome recorded
— NCT06715501 Dec 2024 → Sep 2025 overdue esophageal squamous cell carcinoma First Affiliated Hospital of Ningbo University Enrolling by invitation No outcome recorded
— NCT06714084 Oct 2024 → Dec 2026 expected cervical cancer Hubei Cancer Hospital Enrolling by invitation No outcome recorded
— NCT06553781 Sep 2024 → Sep 2025 overdue melanoma Fudan University Not yet recruiting No outcome recorded
— NCT06551207 Aug 2024 → Dec 2026 expected colorectal cancer Liu Huang Recruiting No outcome recorded
— NCT06265350 Feb 2024 → Jan 2026 overdue hepatocellular carcinoma Sun Yat-sen University Recruiting No outcome recorded
— NCT05800080 Apr 2023 → Feb 2024 gastric cancer Xijing Hospital Unknown No outcome recorded
Comparator or background therapy5 trials
Phase 0 NCT05021120 Background Oct 2021 → Oct 2024 — Akeso Biopharma, Inc. Completed No outcome recorded
Phase 1 NCT06552598 Background Apr 2024 → Apr 2028 expected cervical cancer, endometrial cancer Tongji Hospital Recruiting No outcome recorded
Phase 1 NCT05559554 Comparator Oct 2022 → Mar 2023 — Akeso Completed No outcome recorded
Phase 2 NCT07556640 Comparator Apr 2026 → Apr 2028 expected gastric cancer, gastroesophageal adenocarcinoma, peritoneal carcinomatosis Ruijin Hospital Recruiting No outcome recorded
Phase 3 NCT05489289 Comparator Jan 2023 → Jan 2026 overdue hepatocellular carcinoma Akeso Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 40

DateIssuerRelease
2026-09-01 Akeso Results 卡度尼利联合仑伐替尼及TACE治疗uHCC II期研究发表于BMC Medicine，III期注册性研究高效推进 akesobio.com ↗
研究结果显示，卡度尼利联合仑伐替尼及TACE方案在uHCC患者中展现出令人鼓舞的抗肿瘤活性和可控的安全性.
2026-04-29 Akeso Results 卡度尼利CARE研究为晚期子宫内膜癌一线治疗提供新证据，孙阳教授在 2026 SGO 全体会议环节口头报告 akesobio.com ↗
2026-03-02 Akeso Results CR患者24个月OS率100%！卡度尼利单药治疗R/M宫颈癌关键II期研究长期OS结果在ESGO重磅发布 akesobio.com ↗
在所有达到完全缓解(CR)的受试者中，中位总生存期( OS)尚未达到(NR)，24个月OS率高达100.0%(nominal p=0.0002)；中位无进展生存期(PFS)尚未达到，12个月PFS率高达84.6%(nominal p＜0.0001).
2025-12-12 Akeso Regulatory 第二个国际注册临床！头对头纳武利尤单抗，卡度尼利一线治疗胃癌国际Ⅲ期临床获FDA批准开展 akesobio.com ↗
近日，康方生物（9926.HK）宣布，公司全球首创的PD-1/CTLA-4 双特异性抗体卡度尼利单抗联合化疗，对比化疗联合或不联合纳武利尤单抗，用于HER2阴性、未经治疗的不可切除或转移性胃或胃食管结合部腺癌一线治疗的国际多中心Ⅲ期临床研究（COMPASSION-37/AK104-311），已获得美国食品药品监督管理局（FDA）批准开展.
2025-08-04 Akeso Regulatory 卡度尼利治疗IO耐药HCC国际多中心注册性临床开展 akesobio.com ↗
近日，康方生物自主研发的全球首创的PD-1/CTLA-4双特异性抗体卡度尼利（开坦尼®）联合仑伐替尼对比仑伐替尼用于治疗既往接受过阿替利珠单抗（PD-L1）联合贝伐珠单抗治疗的晚期肝细胞癌（HCC）的随机对照、国际多中心注册性II期临床研究（COMPASSION-36/AK104-225）的临床研究，已获中国国家药品监督管理局（NMPA）和美国食品药品监督管理局（FDA）批准开展.
2025-07-02 Akeso Results 中华医学会权威指南公布：卡度尼利单抗获复发性或转移性宫颈癌一线治疗全人群1类推荐，重塑晚期宫颈癌一线治疗新标准 akesobio.com ↗
2025-06-24 Akeso Results 梁寒教授专访｜卡度尼利单抗一线胃癌全人群适应症成功获批，推动胃癌治疗全线突破 akesobio.com ↗
新辅助卡度尼利单抗联合SOX治疗局部进展期胃癌，初步评估大概有50%的病人经过手术切除后达到了pCR，而且这部分患者是全人群入组，没有考虑PD-L1 CPS表达.
2025-06-05 Akeso Regulatory 一线宫颈癌全人群获批！康方生物PD-1/CTLA-4双抗开坦尼®获批第三项适应症 akesobio.com ↗
公司独立自主研发的全球首创PD-1/CTLA-4双特异性抗体开坦尼®（卡度尼利单抗注射液）联合含铂化疗联合或不联合贝伐珠单抗一线治疗持续、复发或转移性宫颈癌的新适应症已于5月27日获得批准上市.
2025-03-21 Akeso Results SGO 2025丨康方生物卡度尼利联合同步放化疗治疗局部晚期宫颈癌疗效优异 akesobio.com ↗
可评估患者的最佳总缓解率（ORR）达到100%，其中完全缓解（CR）率高达84.8%，部分缓解（PR）率为15.2%，远优于同类型研究数据；中位缓解持续时间（DoR）尚未达到.
2025-01-23 Akeso Results 荣登Nature Medicine！卡度尼利方案1L治疗胃癌Ⅲ期研究结果全文发表 akesobio.com ↗
2024-12-17 Akeso Results 2024 ESMO IO丨无惧PD-L1低表达，卡度尼利单抗联合方案为胃癌患者带来全面获益 akesobio.com ↗
2024-12-06 Akeso Results 韩宝惠教授专访：卡度尼利有望破局免疫耐药，双抗联合方案疗效惊艳，耐受性好 akesobio.com ↗

All press releases naming this drug 41 releases

DateIssuerRelease

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 217 sources stand behind the page.

FieldValueCited text
Known as Cadonilimab “Efficacy of Cadonilimab (AK104) Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS Colorectal Cancer With Liver...” NCT07544784 ↗
151

“Cadonilimab (AK104) is a first-in-class tetravalent bispecific antibody that targets both PD-1 and CTLA-4, showing a manageable safety profile and favorable clinical benefits.” PMID 38280003 ↗ Jan 2024

“Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma” NCT06371157 ↗

“Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks” NCT06789848 ↗

“Cadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6” NCT07400536 ↗

“standard chemotherapy with cadonilimab, 6 mg/kg, is administered every two weeks.” NCT07079462 ↗

“Cadonilimab (AK104) is administered intravenously at 10 mg/kg every 3 weeks.” NCT06035224 ↗

“Cadonilimab is a humanized, bispecific antibody targeting PD-1 and CTLA-4.” NCT06714084 ↗

“Multimodal ablation combined with cadonilimab and fruquintinib” NCT06889610 ↗

“Anti-PD-1 and CTLA-4 Bispecific Antibody, Cadonilimab(AK104)” NCT05505825 ↗

“AK104/cadonilimab (PD-1/CTLA-4 bispecific): A case report.” PMID 36569905 ↗ Dec 2022

Show 141 more sources
Known as AK104 “The purpose of the trial is evaluated Disitamab Vedotin (RC48) plus Cadonilimab (AK104) as first-line therapy for HER2-overexpressing advanced stomach carcinoma, and also check...” NCT06492317 ↗
89

“Recently, cadonilimab (AK104), a bispecific antibody targeting PD-1 and CTLA-4, has demonstrated promising antitumor activity when combined with chemotherapy in advanced...” PMID 40070819 ↗ Feb 2025

“evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable...” NCT06406634 ↗

“AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint...” NCT06552598 ↗

“AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint...” NCT07359235 ↗

“Cadonilimab (AK104) is a first-in-class tetravalent bispecific antibody that targets both PD-1 and CTLA-4, showing a manageable safety profile and favorable clinical benefits.” PMID 38280003 ↗ Jan 2024

“A Phase II Clinical Study of Cadonilimab (AK104) Combined With Chemotherapy in the Treatment of PD-1 Inhibitor Resistant Nasopharyngeal Carcinoma” NCT05790200 ↗

“Cadonilimab (AK104): 10 mg/kg administered via intravenous infusion over 60-120 minutes (minimum 60 minutes) on Day 1 of each 21-day cycle.” NCT07243951 ↗

“Cadonilimab (AK104): 15mg/kg Q3W iv D1 + Lenvatinib: 8 mg (body weight \<60 kg) or 12mg (body weight ≥60 kg) orally QD.” NCT06361758 ↗

“A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors” NCT06427057 ↗

“Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks” NCT06789848 ↗

Show 79 more sources
Known as Cadonilimab (AK104) “Cadonilimab (AK104)” NCT05571644 ↗
Known as Candonilimab “Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer” NCT05853172 ↗
Known as cardonilizumab “Cadonilimab: 15mg/kg Q3W Day1 Select the best TACE treatment strategy. Traditional TACE (cTACE) or DEB-TACE can be selected. TACE treatment can be continued as needed based on...” NCT05925413 ↗
Known as cardonirimab “As a bispecific antibody against PD-1 and CTLA-4, cardonirimab can not only induce the production of a large number of T cells in the early stage of immune response by...” NCT05824494 ↗
Action Inhibit “cadonilimab (anti PD-1 and CTLA-4 bispecific antibody)” PMID 37677918 ↗ Aug 2023
Modality Monoclonal antibody “AK104, a PD-1/CTLA-4 Bispecific Antibody” NCT04547101 ↗
Route Intravenous “Subjects will receive AK104 by intravenous administration.” NCT03261011 ↗
Target CTLA4 “AK104 (anti-PD-1 and CTLA4)” NCT06540729 ↗