This study evaluated a novel combination of DNV3 (anti-LAG-3), toripalimab (anti-PD-1), and chemotherapy (nab-paclitaxel/cisplatin) in 27 Asian patients with unresectable or metastatic melanoma (77.8% [21/27] previously treated with anti-PD-[L]1 and 22.2% [6/27] treatment-naïve mucosal melanoma; subtypes: 13 mucosal, 6 acral, 5 cutaneous, and 3 of unknown primary origin). Therefore, the combination of LAG-3/PD-1 blockade and chemotherapy demonstrated promising efficacy, notably in treatment-naïve mucosal melanoma with liver metastases. (Chinese Clinical Trial Registry number, ChiCTR2400079543).

2 days ago

Journal

LAG3 (Lymphocyte Activating 3)

cisplatin • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel

Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)

P3, N=558, Not yet recruiting, Chipscreen Biosciences, Ltd.

3 days ago

New P3 trial

gemcitabine • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • Auraza (chiauranib)

A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)

P3, N=578, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University

3 days ago

New P3 trial

TP53 (Tumor protein P53) • FAT1 (FAT atypical cadherin 1) • NOTCH3 (Notch Receptor 3)

TP53 mutation

cisplatin • paclitaxel • Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Andewei (benmelstobart)

A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy (clinicaltrials.gov)

P2, N=268, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Sep 2026 --> Sep 2027

4 days ago

Trial completion date • Trial primary completion date

cisplatin • Loqtorzi (toripalimab-tpzi)

Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases (clinicaltrials.gov)

P1/2, N=24, Not yet recruiting, Dan Feng | Trial primary completion date: Dec 2030 --> Dec 2028

5 days ago

Trial primary completion date

MSI (Microsatellite instability)

Loqtorzi (toripalimab-tpzi) • Dupixent (dupilumab)

Exploratory biomarker findings from regorafenib plus toripalimab in patients with refractory metastatic colorectal cancer (REGOTORI study). (PubMed, Gastroenterol Rep (Oxf))

High positive rates of CD3+, CD3+CD8+, CD3+CD8-, and PD-1+CD3+ T cells in the stroma area correlated with prolonged progression-free survival and favorable disease control; however, neither the positive rate of PD-L1 cells nor the density of it in the tumor area was associated with survival and response. In this combination-therapy-focused multi-omics analysis integrating tissue genomics, ctDNA features/dynamics and TME profiling, we identified ctDNA maxAF, HAF-bTMB, bITH, HAF-bITH, mutational status of SMAD4 or PIK3CA and TME markers as predictive or prognostic biomarkers for regorafenib plus toripalimab in refractory mCRC.

5 days ago

Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker

PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • SMAD4 (SMAD family member 4)

PIK3CA mutation

Loqtorzi (toripalimab-tpzi) • Stivarga (regorafenib)

InTRist: Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC (clinicaltrials.gov)

P2, N=50, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting --> Active, not recruiting

7 days ago

Enrollment closed

Loqtorzi (toripalimab-tpzi)

Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases (clinicaltrials.gov)

P1/2, N=24, Not yet recruiting, Dan Feng | Initiation date: Dec 2025 --> Mar 2026

7 days ago

Trial initiation date

MSI (Microsatellite instability)

Loqtorzi (toripalimab-tpzi) • Dupixent (dupilumab)

TianjinCIH: A Single-center, Phase II Clinical Study of Sacituzumab Govitecan Combined With Toripalimab as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC (clinicaltrials.gov)

P2, N=38, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

7 days ago

New P2 trial

EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)

EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR negative

Loqtorzi (toripalimab-tpzi) • Trodelvy (sacituzumab govitecan-hziy)

Anti-Tumor Immunotherapy of Scutellaria Baicalensis-Derived Vesicles on Immune Checkpoint Modulation in Colorectal Cancer. (PubMed, Aging Dis)

Notably, the combination treatment of SBV and TOR exhibited synergistic effects in tumor suppression and reduced the colon toxicity induced by Toripalimab (TOR). Our findings suggested SBV serves as a natural nanomedicine with dual potentials, not only could SBV inhibit PD-L1, but also could enhance the systemic anti-tumor immunity in colorectal cancer while reducing the colon toxicity related with PD-1 blockade, providing new insights into the potential application of PDV in cancer immunotherapy.

9 days ago

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

CD8 (cluster of differentiation 8)

PD-L1 expression

Loqtorzi (toripalimab-tpzi)

ABSK-011-201: A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients (clinicaltrials.gov)

P2, N=118, Enrolling by invitation, Abbisko Therapeutics Co, Ltd | Recruiting --> Enrolling by invitation | N=62 --> 118 | Trial completion date: Oct 2024 --> Dec 2029 | Trial primary completion date: Jul 2024 --> Dec 2028

9 days ago

Enrollment status • Enrollment change • Trial completion date • Trial primary completion date

FGF19 (Fibroblast growth factor 19)

Tecentriq (atezolizumab) • Loqtorzi (toripalimab-tpzi) • irpagratinib (ABSK011)