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- | Fruzaqla (fruquintinib) / Takeda, Kaitanni (cadonilimab) / Akesobio
New P2 trial: Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC (clinicaltrials.gov) - Dec 12, 2023
P2, N=40, Recruiting, Sponsor: Huazhong University of Science and Technology
- Kaitanni (cadonilimab) / Akesobio, Lenvima (lenvatinib) / Eisai, Merck (MSD)
The efficacy and safety of transarterial chemoembolization combined with cadonilimab and lenvatinib for unresectable hepatocellular carcinoma: A phase II clinical trial. (Poster Bd # C3) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_422;
P2
Benefit of control on tumor progression after TACE and lasting survival can be expected. Clinical trial information: NCT05319431.
- | Kaitanni (cadonilimab) / Akesobio, Stivarga (regorafenib) / Bayer
Enrollment open, Metastases: AK104-IIT-C-N1-0057: Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer (clinicaltrials.gov) - Dec 6, 2023
P2, N=30, Recruiting, Sponsor: Tianjin Medical University Cancer Institute and Hospital
Clinical trial information: NCT05319431. Not yet recruiting --> Recruiting
- | Sulanda (surufatinib) / Hutchmed, Kaitanni (cadonilimab) / Akesobio
New trial: A prospective, single-arm, multicenter clinical study of cadonilimab combined with surufatinib in the treatment of progress advanced soft tissue sarcoma after system chemotherapy (EUDRACT) - Dec 5, 2023
P=N/A, N=99, Not yet recruiting, Sponsor: Shanghai Tongren Hospital; Shanghai Tongren Hospital
Not yet recruiting --> Recruiting .
- | Kaitanni (cadonilimab) / Akesobio
New trial, Combination therapy, Real-world evidence, Real-world: Real-world clinical studies of Cadonilimab in combination with chemotherapy + radiotherapy in patients with second- and later-line extensive-stage small cell lung cancer (EUDRACT) - Dec 5, 2023
P=N/A, N=20, Not yet recruiting, Sponsor: Zibo Municipal Hospital; Zibo Municipal Hospital
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- | Kaitanni (cadonilimab) / Akesobio
New P2/3 trial, Tumor mutational burden, IO biomarker: A randomized, controlled, double-blind, multicenter phase II clinical study of PD-1/CTLA-4 dual antibody combined with chemoradiotherapy in the treatment of stage T1-2N2-3/T3-4N0-3M0 nasopharyngeal carcinoma (EUDRACT) - Dec 5, 2023
P2/3, N=64, Not yet recruiting, Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospital
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- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Combination therapy, Metastases: A prospective clinical study to evaluate the efficacy and safety of kadunilimab in combination with neoadjuvant chemotherapy in the treatment of locally advanced cervical cancer (EUDRACT) - Dec 5, 2023
P2, N=30, Not yet recruiting, Sponsor: The First Hospital of Lanzhou University; The First Hospital of Lanzhou University
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- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Efficacy and safety of Cadonilimab combined with gemcitabine and cisplatin in the first-line treatment of unresectable locally advanced or metastatic biliary malignancies (EUDRACT) - Dec 5, 2023
P2, N=65, Not yet recruiting, Sponsor: West China Hospital, Sichuan University; West China Hospital, Sichuan University
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- | Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Efficacy and safety of Cadonilimab(AK104) plus SOX as a neoadjuvant regimen in patients with locally advanced gastric cancer: A single-arm open-label phase II trial (EUDRACT) - Dec 5, 2023
P2, N=10, Recruiting, Sponsor: Department of Oncology, The First People's Hospital Affiliated to Yangtze University,; The First People's Hospital Affiliated to Yangtze University,
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- | Erbitux (cetuximab) / Eli Lilly, Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Cadonilimab + FOLFOX Versus FOLFOX in the Neoadjuvant Treatment of pMMR/MSS Locally Advanced Colorectal Cancer (clinicaltrials.gov) - Dec 4, 2023
P2, N=170, Recruiting, Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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- | Kaitanni (cadonilimab) / Akesobio
New trial, Real-world evidence, Real-world, Metastases: A Prospective Real-world Study of Cadonilimab in Patients With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - Dec 3, 2023
P=N/A, N=670, Not yet recruiting, Sponsor: Gang Chen (101199)
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- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Cadonilimab Plus mFOLFIRINOX as Conversion Therapy in LAPC (clinicaltrials.gov) - Dec 1, 2023
P2, N=30, Not yet recruiting, Sponsor: The First Affiliated Hospital with Nanjing Medical University
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- | Kaitanni (cadonilimab) / Akesobio
Trial completion date, Trial initiation date, Trial primary completion date, Metastases: IC Plus Low-dose Radiation Plus Cadonilimab in LANPC (clinicaltrials.gov) - Nov 28, 2023
P3, N=380, Not yet recruiting, Sponsor: Sun Yat-sen University
. Trial completion date: Sep 2029 --> Dec 2029 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2026 --> Dec 2026
- | Kaitanni (cadonilimab) / Akesobio
Enrollment open, Metastases: Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma (clinicaltrials.gov) - Nov 28, 2023
P3, N=418, Recruiting, Sponsor: Sun Yat-sen University
Trial completion date: Sep 2029 --> Dec 2029 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2026 --> Dec 2026 Not yet recruiting --> Recruiting
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial: Multi-center clinical study of efficacy and safety of Cadonilimab (AK104) combined with albumin-paclitaxel and platinum in first-line treatment of extensive small cell lung cancer (ES-SCLC) (EUDRACT) - Nov 22, 2023
P2, N=27, Not yet recruiting, Sponsor: Zhujiang Hospital of Southern Medical University
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006) (clinicaltrials.gov) - Nov 22, 2023
P2, N=46, Not yet recruiting, Sponsor: Sun Yat-sen University
- | Kaitanni (cadonilimab) / Akesobio
New trial, HEOR, Cost effectiveness: Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer (clinicaltrials.gov) - Nov 21, 2023
P=N/A, N=200, Not yet recruiting, Sponsor: Fujian Cancer Hospital
- | Kaitanni (cadonilimab) / Akesobio
Journal, Metastases: Immunotherapy rechallenge of advanced lung adenocarcinoma with cardonilimab (PD-1/CTLA-4 Bi-specific antibody): a case report. (Pubmed Central) - Nov 20, 2023
Cadonilimab (AK104), a unique bi-specific antibody targeting PD-1/CTLA-4, has similar biological activity but lower toxicity than the combination of CTLA-4 and PD-1 antibodies...The condition of the patient was maintained at stable disease for 6 months. This might provide a new idea and choice for the challenge of immunotherapy resistance.
- | Kaitanni (cadonilimab) / Akesobio, Lenvima (lenvatinib) / Eisai, Merck (MSD)
New P2 trial, Combination therapy: Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC (clinicaltrials.gov) - Nov 18, 2023
P2, N=43, Recruiting, Sponsor: Sun Yat-sen University
- ||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
Enrollment open, Trial completion date, Trial primary completion date: AK104-219: Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - Nov 18, 2023
P2, N=90, Recruiting, Sponsor: Akeso
This might provide a new idea and choice for the challenge of immunotherapy resistance. Not yet recruiting --> Recruiting | Trial completion date: Aug 2027 --> Nov 2027 | Trial primary completion date: Aug 2024 --> Nov 2024
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Combination therapy: A phase II study of cardonilumab (AK104) in combination with chemotherapy in patients with PD-L1 50% or more IIIB and IIIC stage unresectable non-small-cell lung cancer (EUDRACT) - Nov 15, 2023
P2, N=34, Not yet recruiting, Sponsor: Cancer Hospital Affiliated to Shandong first medical University
- | Avastin (bevacizumab) / Roche, Kaitanni (cadonilimab) / Akesobio
Enrollment open, Trial initiation date, Combination therapy, Metastases: Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer (clinicaltrials.gov) - Nov 15, 2023
P2, N=20, Recruiting, Sponsor: Fujian Cancer Hospital
Not yet recruiting --> Recruiting | Trial completion date: Aug 2027 --> Nov 2027 | Trial primary completion date: Aug 2024 --> Nov 2024 Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Nov 2023
- || Kaitanni (cadonilimab) / Akesobio, Lenvima (lenvatinib) / Eisai, Merck (MSD)
P1/2 data, Journal, Metastases: The efficacy and safety of cadonilimab combined with lenvatinib for first-line treatment of advanced hepatocellular carcinoma (COMPASSION-08): a phase Ib/II single-arm clinical trial. (Pubmed Central) - Nov 13, 2023
P1/2
This novel combination therapy showed promising efficacy and manageable toxicity that could provide an option in first-line setting of aHCC. [www.ClinicalTrials.gov], NCT04444167.
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: AK104-IIT-025: Cadonilimab+ Paclitaxel (Albumin-bound) Treat Advanced Gastric Adenocarcinoma With PD-(L)1 Inhibitors Resistance (clinicaltrials.gov) - Nov 7, 2023
P2, N=40, Not yet recruiting, Sponsor: China Medical University, China
- || Kaitanni (cadonilimab) / Akesobio
P1/2 data, Clinical Trial,Phase II, Journal, Metastases: Safety and antitumour activity of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial. (Pubmed Central) - Nov 1, 2023
P1/2
[www.ClinicalTrials.gov], NCT04444167. Cadonilimab showed an encouraging tumour response rate, with a manageable safety profile, suggesting the potential of cadonilimab for the treatment of advanced solid tumours.
- || Kaitanni (cadonilimab) / Akesobio
Enrollment open, Mismatch repair, Metastases: Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer (clinicaltrials.gov) - Oct 25, 2023
P2, N=33, Recruiting, Sponsor: Sun Yat-sen University
Cadonilimab showed an encouraging tumour response rate, with a manageable safety profile, suggesting the potential of cadonilimab for the treatment of advanced solid tumours. Not yet recruiting --> Recruiting
- | Sulanda (surufatinib) / Hutchmed, Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Surufatinib Plus Cadonilimab in Patients With Unresectable or Metastatic Bile Duct Adenocarcinoma (clinicaltrials.gov) - Oct 23, 2023
P2, N=48, Recruiting, Sponsor: Zhejiang Cancer Hospital
- ||| SPH4336 / Shanghai Pharma
Enrollment open, Combination therapy, Monotherapy, Metastases: A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - Oct 19, 2023
P1/2, N=63, Recruiting, Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer, Kaitanni (cadonilimab) / Akesobio
New P2 trial: A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - Oct 9, 2023
P2, N=36, Recruiting, Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Kaitanni (cadonilimab) / Akesobio
Real-world outcomes of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus chemotherapy as first-line treatment in advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS?5 (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_757;
Results From Aug 2022 to Aug 2023, 22 pts were enrolled, of which 14 (63.6%) received cadonilimab (10mg/kg, q3w) plus SOX, 4 (18.2%) received cadonilimab (10mg/kg, q3w) plus XELOX and 3 (13.6%) received cadonilimab (6mg/kg, q2w) plus FOLFOX...Conclusions This real-world analysis further confirmed the promising efficacy and safety of cadonilimab plus chemotherapy as first-line treatment in advanced G/GEJ cancer pts with PD-L1 CPS?5. Further exploration is ongoing and the updated analysis in a larger population is expected in the future.
- Kaitanni (cadonilimab) / Akesobio
Neoadjuvant cadonilimab (PD-1/CTLA-4 bispecific antibody) plus transhepatic arterial infusion chemotherapy (HAIC) for resectable multinodular CNLC Ib/IIa hepatocellular carcinoma (Car-Hero) (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_750;
One pt experienced postoperative severe but curable bacterial hepatic abscess related to bilioenteric anastomosis and diabetes mellitus. Conclusions This study preliminarily demonstrated that neoadjuvant cadonilimab plus FOLFOX-HAIC had a promising antitumor activity and a manageable safety for the resectable multinodular HCC.
- Avastin (bevacizumab) / Roche, Kaitanni (cadonilimab) / Akesobio
A phase II study of cadonilimab + FOLFOXIRI and bevacizumab as initial therapy for unresectable proficient mismatch repair/microsatellite stable (pMMR/MSS) metastatic colorectal cancer (mCRC) (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_702;
P2
Conclusions This study preliminarily demonstrated that neoadjuvant cadonilimab plus FOLFOX-HAIC had a promising antitumor activity and a manageable safety for the resectable multinodular HCC. A recent trial of botensilimab (next-generation anti
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Cadonilimab (AK104) Plus Chemotherapy in Patients With Recurrent or Advanced Endometrial Cancer (clinicaltrials.gov) - Oct 3, 2023
P2, N=45, Not yet recruiting, Sponsor: Fujian Cancer Hospital
- | Kaitanni (cadonilimab) / Akesobio
New trial, Metastases: AK104 Combined With I-125 Brachytherapy for Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - Oct 2, 2023
P=N/A, N=18, Not yet recruiting, Sponsor: Peking University Third Hospital
- | Inlyta (axitinib) / Pfizer, Kaitanni (cadonilimab) / Akesobio
Trial initiation date, Metastases: A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma (clinicaltrials.gov) - Sep 25, 2023
P1/2, N=33, Not yet recruiting, Sponsor: Hao Zeng
A recent trial of botensilimab (next-generation anti Initiation date: Jun 2023 --> Sep 2023
- | Kaitanni (cadonilimab) / Akesobio
Trial primary completion date, Combination therapy, IO biomarker: A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - Sep 21, 2023
P1/2, N=42, Recruiting, Sponsor: Akeso
Initiation date: Jun 2023 --> Sep 2023 Trial primary completion date: Dec 2023 --> Dec 2024
- ||| lancastotug (AK127) / Akesobio, Kaitanni (cadonilimab) / Akesobio
Enrollment open, Combination therapy, Metastases: A Phase Ia/Ib Open Label?Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - Sep 21, 2023
P1a/1b, N=205, Recruiting, Sponsor: Akeso
Trial primary completion date: Dec 2023 --> Dec 2024 Not yet recruiting --> Recruiting
- ||| Kaitanni (cadonilimab) / Akesobio
Enrollment open, Enrollment change, Trial completion date, Monotherapy, Metastases: A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - Sep 21, 2023
P2, N=70, Recruiting, Sponsor: Akeso
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | N=40 --> 70 | Trial completion date: Aug 2024 --> Dec 2025
- | Kaitanni (cadonilimab) / Akesobio, Lenvima (lenvatinib) / Eisai, Merck (MSD)
New P1/2 trial: Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (clinicaltrials.gov) - Sep 15, 2023
P1/2, N=30, Recruiting, Sponsor: First Affiliated Hospital of Guangxi Medical University
- | Kaitanni (cadonilimab) / Akesobio, Lenvima (lenvatinib) / Eisai, Merck (MSD)
New P2 trial, Metastases: A Study of Cadonilimab?AK104? Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - Sep 13, 2023
P2, N=28, Recruiting, Sponsor: RenJi Hospital
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Combination therapy, Metastases: NCCCNRHNSCC: Neoadjuvant Cadonilimab in Combination With Cisplatin and Nab-paclitaxel in Resectable Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Sep 5, 2023
P2, N=30, Recruiting, Sponsor: Xuekui Liu
- | Kaitanni (cadonilimab) / Akesobio
Trial completion date, Trial primary completion date: Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix (clinicaltrials.gov) - Aug 28, 2023
P2, N=18, Recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting | N=40 --> 70 | Trial completion date: Aug 2024 --> Dec 2025 Trial completion date: Sep 2023 --> Aug 2025 | Trial primary completion date: Sep 2023 --> Aug 2025
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: Cadonilimab Plus Nab-Paclitaxel for Recurrent or Metastatic Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Aug 24, 2023
P2, N=20, Recruiting, Sponsor: Tianjin Medical University Second Hospital
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial: ACHELOUS: Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative (clinicaltrials.gov) - Aug 21, 2023
P2, N=49, Recruiting, Sponsor: Qian Chu
- | Kaitanni (cadonilimab) / Akesobio
Trial completion date, Trial primary completion date: Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix (clinicaltrials.gov) - Aug 16, 2023
P2, N=18, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Sep 2023 --> Aug 2025 | Trial primary completion date: Sep 2023 --> Aug 2025 Trial completion date: Aug 2025 --> Sep 2023 | Trial primary completion date: Aug 2025 --> Sep 2023
- | Kaitanni (cadonilimab) / Akesobio
New P1/2 trial, Combination therapy, Metastases: ZSAB-Calm: Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody (clinicaltrials.gov) - Aug 16, 2023
P1/2, N=96, Recruiting, Sponsor: Shanghai Zhongshan Hospital
- |||||||||| Kaitanni (cadonilimab) / Akesobio
New P3 trial: A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (clinicaltrials.gov) - Aug 14, 2023
P3, N=642, Not yet recruiting, Sponsor: Akeso
- | Kaitanni (cadonilimab) / Akesobio, Focus V (anlotinib) / Advenchen, Sino Biopharm
New P2 trial, Metastases: Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of PD-1 Combined With Platinum-containing Chemotherapy (clinicaltrials.gov) - Aug 14, 2023
P2, N=35, Recruiting, Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
- || Kaitanni (cadonilimab) / Akesobio
New P2 trial, Mismatch repair, Metastases: Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer (clinicaltrials.gov) - Aug 8, 2023
P2, N=33, Not yet recruiting, Sponsor: Sun Yat-sen University
- | Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: BicureX: Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer (clinicaltrials.gov) - Aug 7, 2023
P2, N=65, Recruiting, Sponsor: West China Hospital