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DRUG:

Kaitanni (cadonilimab)

i
Other names: AK104, AK-104, AK 104
Company:
Akesobio
Drug class:
PD1 inhibitor, CTLA4 inhibitor
Related drugs:
3d
AK104-217: A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
P2, N=78, Recruiting, Akeso | Not yet recruiting --> Recruiting | N=60 --> 78 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
7d
A surprising complete response to cadonilimab in a primary metastatic cervical cancer: a case report. (PubMed, Front Immunol)
Unfortunately, the patient progressed rapidly during maintenance therapy when cadonilimab was replaced by sintilimab, the monoclonal antibody against PD-1, indicating the more powerful anti-tumor activity of dual blockade immunotherapy. To conclude, cadonilimab offers a promising and effective therapeutic approach for R/M CC. Notably, HER-2 is also expected to be a new reference target for cadonilimab therapy.
Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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PD-L1 negative • EGFR positive
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Tyvyt (sintilimab) • Kaitanni (cadonilimab)
8d
Candonilimab and ATRA Acid for Prevention of Oral Cancer Recurrence in Patients With OPL (clinicaltrials.gov)
P2, N=23, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
New P2 trial
|
Kaitanni (cadonilimab)
13d
Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastro-oesophageal junction adenocarcinoma: study protocol for a single-arm, phase II clinical trial. (PubMed, BMJ Open)
Eligible patients will be registered and receive three cycles of oxaliplatin and S-1 (SOX) regimen in combination with cadonilimab...The results of the study may provide more evidence for neoadjuvant immunotherapy combined with chemotherapy in locally advanced G/GOJ adenocarcinoma. ClinicalTrials.gov, NCT05948449.
Clinical protocol • P2 data • Journal • Metastases
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CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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oxaliplatin • Kaitanni (cadonilimab) • Teysuno (gimeracil/oteracil/tegafur)
14d
AK104-IIT-C-N1-0122: AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC (clinicaltrials.gov)
P2, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Recruiting
Enrollment open • Metastases
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gemcitabine • Rituxan (rituximab) • albumin-bound paclitaxel • Kaitanni (cadonilimab)
15d
New trial • Metastases
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carboplatin • paclitaxel • Kaitanni (cadonilimab)
16d
CNCMT:a Multi-center, Prospective, Single-arm Study (clinicaltrials.gov)
P=N/A, N=20, Enrolling by invitation, Hubei Cancer Hospital
New trial • Metastases
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Kaitanni (cadonilimab)
16d
SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC) (clinicaltrials.gov)
P2, N=51, Recruiting, Hubei Cancer Hospital | Not yet recruiting --> Recruiting
Enrollment open
|
carboplatin • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • Kaitanni (cadonilimab)
24d
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours (clinicaltrials.gov)
P1, N=66, Active, not recruiting, Akesobio Australia Pty Ltd | Recruiting --> Active, not recruiting | N=143 --> 66 | Trial primary completion date: Jan 2025 --> Oct 2024
Enrollment closed • Enrollment change • Trial primary completion date • Combination therapy • Metastases
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Kaitanni (cadonilimab) • lancastotug (AK127)
1m
Neoadjuvant cadonilimab plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma: A multicenter, phase 2 study. (PubMed, Med)
Neoadjuvant cadonilimab plus FLOT chemotherapy treatment exhibits promising efficacy with manageable toxicities in locally advanced G/GEJ adenocarcinoma, providing preliminary evidence for further investigation.
P2 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
|
docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
1m
Single-arm clinical study on the treatment of locally advanced cervical cancer with camrelizumab combined with concurrent chemoradiotherapy (ChiCTR2400089150)
P=N/A, N=75, Not yet recruiting, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine; Shanghai First Maternity and Infant Hospital, Tongji University Sc
New trial • Metastases
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AiRuiKa (camrelizumab) • Kaitanni (cadonilimab)
1m
Study on Cadonilimab Plus mFOLFIRINOX in patients with locally advanced pancreatic cancer (ChiCTR2400088986)
P=N/A, N=30, Not yet recruiting, Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi
New trial • Metastases
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CA 19-9 (Cancer antigen 19-9)
|
oxaliplatin • irinotecan • Kaitanni (cadonilimab)
1m
AK104 in combination with AK112 in an exploratory, multi-cohort stage II treatment of recurrent ovarian cancer study (ChiCTR2400090899)
P2, N=172, Not yet recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
New P2 trial • Combination therapy • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Kaitanni (cadonilimab) • Yidafan (ivonescimab)
1m
New P2 trial • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS wild-type • RAS wild-type
|
Fruzaqla (fruquintinib) • Kaitanni (cadonilimab)
1m
New P2 trial • Metastases
|
cisplatin • gemcitabine • Kaitanni (cadonilimab)
1m
New P2 trial • Metastases
|
Focus V (anlotinib) • Kaitanni (cadonilimab)
2ms
AK104-214: AK104 in Neoadjuvant Treatment of Cervical Cancer (clinicaltrials.gov)
P2, N=14, Completed, Akeso | Not yet recruiting --> Completed | N=30 --> 14 | Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Mar 2023 --> Sep 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
Kaitanni (cadonilimab)
2ms
New P3 trial • Metastases
|
cisplatin • capecitabine • albumin-bound paclitaxel • Kaitanni (cadonilimab)
2ms
New P2 trial • Metastases
|
albumin-bound paclitaxel • Kaitanni (cadonilimab) • ifebemtinib (IN10018)
2ms
New P1/2 trial • Metastases
|
Herceptin (trastuzumab) • 5-fluorouracil • capecitabine • oxaliplatin • Aidixi (disitamab vedotin) • leucovorin calcium • Kaitanni (cadonilimab)
2ms
Oral Lichenoid lesions induced by programmed cell death protein 1 and cytotoxic T-lymphocyte-associated protein 4 bispecific antibody: a case report. (PubMed, BMC Oral Health)
This report marks the first documented instance of an oral adverse effect associated with Cadonilimab use. It underscores that administration of this agent may lead to significant lichenoid lesions and erosions within the oral cavity-an issue warranting increased vigilance from both oncologists and stomatologists.
Journal
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CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD4 (CD4 Molecule) • CD68 (CD68 Molecule)
|
Kaitanni (cadonilimab)
2ms
New P1/2 trial • Metastases
|
gemcitabine • albumin-bound paclitaxel • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
2ms
Trial completion date
|
5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
2ms
Cadonilimab (PD-1/CTLA-4) in combination with lenvatinib in unresectable hepatocellular carcinoma (uHCC): A retrospective real-world study. (PubMed, Heliyon)
TRAEs of grade 3 or higher occurred in 51.7 % of patients, with no grade 4 TRAEs observed. This study demonstrated the efficacy and safety of this combination, potentially improving outcomes as a first-line therapy, and offering a novel therapeutic approach for advanced HCC.
Retrospective data • Journal • Combination therapy • Real-world evidence • Real-world
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PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Lenvima (lenvatinib) • Kaitanni (cadonilimab)
2ms
The efficacy and safety of a novel PD-1/CTLA-4 bispecific antibody cadonilimab (AK104) in advanced non-small cell lung cancer: A multicenter retrospective observational study. (PubMed, Thorac Cancer)
In this heavily pretreated cohort of advanced NSCLC patients, cadonilimab-based regimens showed moderate antitumor efficacy with a generally tolerable and manageable safety profile. However, more evidence is needed to support the administration of cadonilimab in NSCLC patients refractory to previous anti-PD-1/PD-L1 therapy.
Observational data • Retrospective data • Journal • Metastases
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PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Kaitanni (cadonilimab)
3ms
New P2 trial
|
carboplatin • paclitaxel • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
3ms
New P3 trial • Metastases
|
Kaitanni (cadonilimab) • Cejemly (sugemalimab)
3ms
Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer (clinicaltrials.gov)
P2, N=33, Recruiting, Chongqing University Cancer Hospital | Trial primary completion date: Jun 2024 --> Dec 2024
Trial primary completion date • Metastases
|
Kaitanni (cadonilimab)
3ms
TALENP001: Neoadjuvant Triple Therapy for Resectable HCC (clinicaltrials.gov)
P=N/A, N=20, Recruiting, Fujian Provincial Hospital | Not yet recruiting --> Recruiting
Enrollment open
|
Lenvima (lenvatinib) • Kaitanni (cadonilimab)
3ms
Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer (clinicaltrials.gov)
P2, N=50, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting | Initiation date: Mar 2024 --> Sep 2024
Enrollment open • Trial initiation date
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PD-L1 (Programmed death ligand 1)
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cisplatin • paclitaxel • Kaitanni (cadonilimab)
3ms
A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic/Oligometastatic Renal Cell Carcinoma (clinicaltrials.gov)
P=N/A, N=60, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New trial • Metastases
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Kaitanni (cadonilimab) • Fumena (vorolanib)
3ms
New trial • Metastases
|
paclitaxel • oxaliplatin • Kaitanni (cadonilimab)
3ms
New trial • Metastases
|
Kaitanni (cadonilimab)
3ms
New P3 trial • Combination therapy • Metastases
|
Lenvima (lenvatinib) • Kaitanni (cadonilimab)
3ms
New P2 trial
|
Avastin (bevacizumab) • Kaitanni (cadonilimab)
3ms
Nanoliposomal irinotecan in combination with Cadonilimab in patients with second line extensive-stage small cell lung cancer: a phase II study (ChiCTR2400087003)
P2, N=30, Recruiting, Cancer Hospital Affiliated of Shandong First Medical University; Cancer Hospital Affiliated of Shandong First Medical University
New P2 trial • Combination therapy
|
Kaitanni (cadonilimab) • Onivyde (nanoliposomal irinotecan)
3ms
New P2 trial • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
|
MSI-H/dMMR • HER-2 negative
|
5-fluorouracil • Fruzaqla (fruquintinib) • leucovorin calcium • Kaitanni (cadonilimab)
3ms
New P2 trial • Metastases
|
gemcitabine • oxaliplatin • Epidaza (chidamide) • Kaitanni (cadonilimab)
3ms
A Phase II, Single-arm, Multicenter Clinical Trial of Definitive Treatment with Cadonilimab, Paclitaxel, Cisplatin and Radiation for the Treatment of Locally Recurrent and Oligometastatic Endometrial Carcinoma (ChiCTR2400087571)
P2, N=30, Recruiting, Shandong Cancer Hospital Affiliated to Shandong First Medical University; Shandong Cancer Hospital Affiliated to Shandong First Medical University
New P2 trial • Metastases
|
cisplatin • paclitaxel • Kaitanni (cadonilimab)
3ms
Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer (clinicaltrials.gov)
P=N/A, N=200, Recruiting, Fujian Cancer Hospital | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2026 --> Dec 2024
Enrollment open • Trial primary completion date • HEOR • Cost effectiveness
|
Kaitanni (cadonilimab)
3ms
New P2 trial • Combination therapy • Metastases
|
capecitabine • Kaitanni (cadonilimab) • tecotabart vedotin (LM-302)