Clinical trials: Immune Checkpoint Inhibitor
Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non-Small Cell Lung Carcinoma
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet…
- Conditions
- Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non-Small Cell Lung Carcinoma, Metastatic Non-squamous Non Small Cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Carcinoma
- Trial name
- VIRO-25 (NCT06463665)
- Testing
- Olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC
- Where
- 15 sites in United States
- Volunteers
- 142 people
- Sponsor
- Genelux Corporation
Breast Cancer (Triple Negative Breast Cancer (TNBC))
Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with…
- Trial name
- NCT07487519
- Testing
- HLX43 DOSE 1 IN ≥2L TNBC, HLX43 DOSE 2 IN ≥2L TNBC, HLX43 DOSE 1 + HLX10
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Shanghai Henlius Biotech
Urothelial Carcinoma
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic…
- Trial name
- FIDES-02 (NCT04045613)
- Testing
- Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg, Derazantinib 300 mg once daily+ atezolizumab 1200 mg
- Where
- 66 sites in United States, Australia and 12 more
- Volunteers
- 95 people
- Sponsor
- Basilea Pharmaceutica
Adult Solid Tumor
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune…
- Trial name
- NCT04084951
- Testing
- SQZ-PBMC-HPV, Atezolizumab, Ipilimumab
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- SQZ Biotechnologies
Small Cell Lung Cancer
Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small…
- Trial name
- NCT07231445
- Testing
- ZG006, Serplulimab
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Advanced Solid Tumor, Metastatic Solid Tumor
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
- Trial name
- NCT07213830
- Testing
- IPN01203
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 102 people
- Sponsor
- Ipsen
Glioblastoma, Recurrent Glioblastoma
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
This Phase 2 single arm trial in patients with rGBM will characterize the efficacy, safety, tolerability and initial efficacy of lerapolturev intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and…
- Conditions
- Glioblastoma, Recurrent Glioblastoma, Supratentorial Glioblastoma, Brain Tumor
- Trial name
- NCT04479241
- Testing
- lerapolturev, pembrolizumab
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Istari Oncology, Inc.
Platinum-refractory Ovarian Carcinoma, Platinum-resistant Ovarian Cancer
Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer.
This is an open-label, phase 1/1b, dose-escalation, multicenter and multinational trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab, or Pembrolizumab and Pegylated Liposomal…
- Conditions
- Platinum-refractory Ovarian Carcinoma, Platinum-resistant Ovarian Cancer, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma
- Trial name
- PROTA (NCT05271318)
- Testing
- TILT-123, pembrolizumab, pegylated liposomal doxorubicin
- Where
- 3 sites in United States, Finland
- Volunteers
- 29 people
- Sponsor
- TILT Biotherapeutics Ltd.
HCC - Hepatocellular Carcinoma
Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma
The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors.
- Trial name
- NCT07310173
- Testing
- AST-3424, Regorafenib Tablets
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)
This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig…
- Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC), Colorectal Cancer
- Trial name
- NCT05482893
- Testing
- Spevatamig (PT886), Paclitaxel, Gemcitabine
- Where
- 11 sites in United States
- Volunteers
- 350 people
- Sponsor
- Phanes Therapeutics
Advanced Solid Tumor, Advanced Lymphoma
Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma
This clinical trial is evaluating a drug called SNX281 given by itself and in combination with pembrolizumab (KEYTRUDA®) in participants with advanced solid tumors and lymphoma.
- Trial name
- NCT04609579
- Testing
- SNX281, pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Stingthera, Inc.
Advanced Solid Tumor
A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)
The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.
- Trial name
- NCT05231746
- Testing
- hSTC810
- Where
- 5 sites in United States, South Korea
- Volunteers
- 47 people
- Sponsor
- STCube, Inc.
Acute Myeloid Leukemia, Lymphoma, Mantle-Cell
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer
The goal of this clinical trial is To assess the safety and tolerability of PEP07 administered orally as a single dose and at escalating dose levels, and, to determine the dose-limiting toxicity (DLT) of study treatment in…
- Trial name
- NCT05659732
- Testing
- PEP07
- Where
- 5 sites in Australia, Taiwan
- Volunteers
- 32 people
- Sponsor
- PharmaEngine
Neoplasms
Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy
The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic…
- Trial name
- NCT03333655
- Testing
- Biopsy
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 15 people
- Sponsor
- Hoffmann-La Roche
Advanced or Metastatic Solid Tumors, Microsatellite Instability Low
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab.
- Conditions
- Advanced or Metastatic Solid Tumors, Microsatellite Instability Low, Microsatellite Instability High, Microsatellite Stable
- Trial name
- NCT05572684
- Testing
- NC410, pembrolizumab
- Where
- 17 sites in United States
- Volunteers
- 97 people
- Sponsor
- NextCure, Inc.
Melanoma
Retrospective Assessment of AE-Related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
This was a retrospective cohort study using Truven Health Analytics' MarketScan Commercial Claims and Encounters and Medicare Supplement and Coordination of Benefit administrative claims databases.
- Trial name
- NCT05874817
- Where
- United States
- Volunteers
- 17,517 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors, Genital Neoplasm, Female
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants…
- Conditions
- Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm
- Trial name
- START-001 (NCT05592626)
- Testing
- STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere)
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 366 people
- Sponsor
- Marengo Therapeutics, Inc.
Advanced Solid Tumors, Lymphoma
FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance.
- Conditions
- Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer
- Trial name
- NCT03841110
- Testing
- FT500, Nivolumab, Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 37 people
- Sponsor
- Fate Therapeutics
Non Small Cell Lung Cancer, Breast Cancer
Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.
This is an observational clinical trial, aiming to investigate whether the ctDNA dynamics could predict early response to ICIs in patients with advanced-stage cancer.
- Conditions
- Non Small Cell Lung Cancer, Breast Cancer, Colorectal Cancer, Gastric Cancer
- Trial name
- PTC-IMPACT (NCT06227728)
- Where
- 2 sites in Vietnam
- Volunteers
- 50 people
- Sponsor
- Gene Solutions
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI…
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Carcinoma), NSCLC
- Trial name
- SIGNAL-IO 301 (NCT07689812)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Volunteers
- 920 people
- Sponsor
- Natera, Inc.