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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:
2d
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
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docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
8d
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
|
AiRuiKa (camrelizumab) • Kaitanni (cadonilimab)
8d
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
|
CA 19-9 (Cancer antigen 19-9)
|
oxaliplatin • irinotecan • Kaitanni (cadonilimab)
8d
New P2 trial • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
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KRAS wild-type • RAS wild-type
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Fruzaqla (fruquintinib) • Kaitanni (cadonilimab)
8d
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
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PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
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Kaitanni (cadonilimab) • Yidafan (ivonescimab)
8d
New P2 trial • Metastases
|
cisplatin • gemcitabine • Kaitanni (cadonilimab)
10d
New P2 trial • Metastases
|
Focus V (anlotinib) • Kaitanni (cadonilimab)
17d
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)
19d
New P3 trial • Metastases
|
cisplatin • capecitabine • albumin-bound paclitaxel • Kaitanni (cadonilimab)
26d
New P2 trial • Metastases
|
albumin-bound paclitaxel • Kaitanni (cadonilimab) • ifebemtinib (IN10018)
28d
New P1/2 trial • Metastases
|
Herceptin (trastuzumab) • 5-fluorouracil • capecitabine • oxaliplatin • Aidixi (disitamab vedotin) • leucovorin calcium • Kaitanni (cadonilimab)
30d
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)
1m
New P1/2 trial • Metastases
|
gemcitabine • albumin-bound paclitaxel • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
1m
Trial completion date
|
5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
1m
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
|
PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Lenvima (lenvatinib) • Kaitanni (cadonilimab)
1m
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
|
PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Kaitanni (cadonilimab)
2ms
New P2 trial
|
carboplatin • paclitaxel • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
2ms
New P3 trial • Metastases
|
Kaitanni (cadonilimab) • Cejemly (sugemalimab)
2ms
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)
2ms
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)
2ms
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)
|
cisplatin • paclitaxel • Kaitanni (cadonilimab)
2ms
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
|
Kaitanni (cadonilimab) • Fumena (vorolanib)
2ms
New trial • Metastases
|
paclitaxel • oxaliplatin • Kaitanni (cadonilimab)
2ms
New trial • Metastases
|
Kaitanni (cadonilimab)
2ms
New P3 trial • Combination therapy • Metastases
|
Lenvima (lenvatinib) • Kaitanni (cadonilimab)
2ms
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)
2ms
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)
2ms
New P2 trial
|
Avastin (bevacizumab) • Kaitanni (cadonilimab)
2ms
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)
2ms
New P2 trial • Metastases
|
gemcitabine • oxaliplatin • Epidaza (chidamide) • Kaitanni (cadonilimab)
2ms
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
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Kaitanni (cadonilimab)
2ms
New P2 trial • Combination therapy • Metastases
|
capecitabine • Kaitanni (cadonilimab) • BMS-986476
2ms
Good response to cadonilimab as first-line treatment in superaged patient with advanced gastric cancer: a case report. (PubMed, Immunotherapy)
Despite these changes, the patient still exhibited a stable disease condition for a year until now. This case report highlights the potential of cadonilimab in the treatment of superaged patients with advanced gastric cancer, while the efficacy and safety of it need to be further evaluated.
Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-1 (Programmed cell death 1)
|
HER-2 negative
|
Kaitanni (cadonilimab)
3ms
Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients (clinicaltrials.gov)
P1/2, N=37, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P1/2 trial
|
Kaitanni (cadonilimab) • Fumena (vorolanib)
3ms
Enrollment open • Metastases
|
cisplatin • carboplatin • Kaitanni (cadonilimab)
3ms
TALENP001: Neoadjuvant Triple Therapy for Resectable HCC (clinicaltrials.gov)
P=N/A, N=20, Not yet recruiting, Fujian Provincial Hospital
New trial
|
Lenvima (lenvatinib) • Kaitanni (cadonilimab)
3ms
New P2 trial • Combination therapy
|
Kaitanni (cadonilimab) • Yidafan (ivonescimab)
3ms
New trial • Metastases
|
BRAF (B-raf proto-oncogene)
|
Fruzaqla (fruquintinib) • Kaitanni (cadonilimab)
3ms
Enrollment closed • Metastases
|
cisplatin • Kaitanni (cadonilimab)
3ms
New P3 trial • Metastases
|
carboplatin • docetaxel • Kaitanni (cadonilimab)
3ms
New P2 trial • Combination therapy • IO biomarker
|
MSI (Microsatellite instability)
|
Avastin (bevacizumab) • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)