The TMEp phase integrated stereotactic body radiotherapy (SBRT), low-dose etoposide, and anlotinib, followed by CI with the programmed death 1 (PD-1)/cytotoxic T lymphocyte antigen 4 (CTLA-4) bispecific antibody cadonilimab and concurrent probiotic supplementation...The TMEp-CI-M platform may enhance the efficacy of immunotherapy in ES-SCLC, enabling durable responses even in patients with brainstem metastases. Although this platform has demonstrated promise across multiple tumor types, further prospective and mechanistic studies are warranted to confirm its clinical utility.

1 day ago

Journal

PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)

PD-L1 negative

Focus V (anlotinib) • etoposide IV • Kaitanni (cadonilimab)

Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial (clinicaltrials.gov)

P2, N=134, Not yet recruiting, Obstetrics & Gynecology Hospital of Fudan University

3 days ago

New P2 trial

Kaitanni (cadonilimab)

Cadonilimab plus chemotherapy as first-line treatment in PD-L1-negative advanced non-small cell lung cancer: a phase II clinical trial. (PubMed, Nat Commun)

Baseline differentially methylated fragments scores show a significant correlation with PFS, with low-risk patients demonstrating a longer median PFS compared to high-risk patients (11.4 months versus 6.9 months). Overall, first-line cadonilimab plus chemotherapy shows an encouraging efficacy with a manageable safety profile for challenging-to-treat PD-L1-negative advanced NSCLC, warranting further evaluation in controlled studies.

7 days ago

P2 data • Journal • PD(L)-1 Biomarker • IO biomarker

CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)

PD-L1 expression • PD-L1 overexpression • PD-L1 negative

Kaitanni (cadonilimab)

AK117-204: A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors (clinicaltrials.gov)

P1/2, N=128, Completed, Akeso | Trial completion date: Mar 2024 --> May 2026 | Trial primary completion date: Mar 2023 --> May 2026 | Recruiting --> Completed

8 days ago

Trial completion • Trial completion date • Trial primary completion date

cisplatin • paclitaxel • docetaxel • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • Kaitanni (cadonilimab) • ligufalimab (AK117)

AK104-215: A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)

P2, N=44, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jan 2026 | Trial primary completion date: Jun 2025 --> Jan 2026

9 days ago

Trial completion • Trial completion date • Trial primary completion date

docetaxel • Kaitanni (cadonilimab)

A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC (clinicaltrials.gov)

P1/2, N=36, Completed, Sun Yat-sen University | Trial completion date: Feb 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Mar 2026 | Active, not recruiting --> Completed

9 days ago

Trial completion • Trial completion date • Trial primary completion date

Stivarga (regorafenib) • Kaitanni (cadonilimab)

10d

Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer (clinicaltrials.gov)

P2, N=26, Active, not recruiting, West China Hospital

10 days ago

New P2 trial

Focus V (anlotinib) • Kaitanni (cadonilimab)

13d

A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer (clinicaltrials.gov)

P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center

13 days ago

New P2 trial

HER-2 (Human epidermal growth factor receptor 2)

HER-2 amplification • HER-2 negative

Kaitanni (cadonilimab)

15d

CATPCC-01: Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer (clinicaltrials.gov)

P2, N=29, Active, not recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting --> Active, not recruiting | Trial completion date: Oct 2027 --> Apr 2029

15 days ago

Enrollment closed • Trial completion date

PD-L1 (Programmed death ligand 1)

cisplatin • albumin-bound paclitaxel • Kaitanni (cadonilimab)

18d

A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations (clinicaltrials.gov)

P1, N=158, Not yet recruiting, Akeso

18 days ago

New P1 trial

Kaitanni (cadonilimab)

25d

PRaG5.0 combined with chemotherapy and sequential chemoimmunotherapy for massive SMARCA4-deficient undifferentiated tumor of the cervix: case report. (PubMed, Front Immunol)

This regimen employs short-course stereotactic body radiotherapy (SBRT, 24Gy/3Fx) as the radiotherapy component, combined with cadonilimab (a PD-1/CTLA-4 bispecific antibody), GM-CSF and thymosin α1 to form the PRaG5.0, alongside chemotherapy with nab-paclitaxel...The patient's progression-free survival (PFS) now exceeds 12 months. This case indicates that for massive, refractory cervical tumors, PRaG5.0 combined with chemotherapy followed by sequential chemoimmunotherapy may offer an effective approach for controlling disease and extending survival.

25 days ago

Journal

PD-1 (Programmed cell death 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • CSF2 (Colony stimulating factor 2)

albumin-bound paclitaxel • Kaitanni (cadonilimab) • Zadaxin (thymalfasin)

27d

CSWOG-C03: Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer (clinicaltrials.gov)

P1/2, N=28, Recruiting, Sun Yat-sen University | Trial completion date: Jul 2027 --> Dec 2028 | Trial primary completion date: Jul 2025 --> Sep 2026

27 days ago

Trial completion date • Trial primary completion date • Mismatch repair • MSI-H • dMMR

PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)

MSI-H/dMMR

Kaitanni (cadonilimab)