Clinical trials: Microsatellite Instability-High
Immunotherapy, Cancer
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
- Conditions
- Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder
- Trial name
- ELEPHAS-02 (NCT05520099)
- Testing
- Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
- Where
- 12 sites in United States
- Volunteers
- 416 people
- Sponsor
- Elephas
Neoplasms, Rectal
A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer
This study is conducted in adults with rectal cancer that has a certain genetic type. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to…
- Trial name
- DuraSTAR (NCT07740720)
- Testing
- Dostarlimab
- Volunteers
- 90 people
- Sponsor
- GlaxoSmithKline
Thyroid Cancer, Renal Cell Carcinoma
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
- Conditions
- Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Trial name
- NCT04234113
- Testing
- Nanrilkefusp alfa, Pembrolizumab
- Where
- 12 sites in United States, Czechia and 2 more
- Volunteers
- 115 people
- Sponsor
- SOTIO Biotech AG
Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed…
- Conditions
- Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer
- Trial name
- NCT06047379
- Testing
- NEO212 Oral Capsule, Ipilimumab, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Neonc Technologies, Inc.
Colorectal Cancer
Circulating Tumor DNA (ctDNA) as a Predictive Biomarker for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients
dMMR/MSI-H colorectal cancer patients are the dominant population of immunotherapy/neoadjuvant immunotherapy, but imaging evaluation of immunotherapy efficacy is insufficient.
- Trial name
- NCT06098560
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Geneplus-Beijing Co. Ltd.
Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer…
- Trial name
- NCT07403721
- Testing
- AMG 436
- Where
- 27 sites in United States, Australia and 8 more
- Volunteers
- 464 people
- Sponsor
- Amgen
Solid Tumor, Adult, HCC - Hepatocellular Carcinoma
Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors
INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with…
- Conditions
- Solid Tumor, Adult, HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Pancreatic Adenocarcinoma
- Trial name
- NCT05651022
- Testing
- Decoy20, Tislelizumab
- Where
- 12 sites in United States
- Volunteers
- 120 people
- Sponsor
- Indaptus Therapeutics, Inc
Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
- Conditions
- Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Esophageal Cancer
- Trial name
- NCT03538028
- Testing
- INCAGN02385
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Incyte Biosciences International Sàrl
Advanced Solid Tumors
A Single-Arm, Open-Label Phase Ia/Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of FS-207 in Patients With Advanced Solid Tumors With High Microsatellite Instability (MSI-H)
This is a Phase Ia/Ib clinical study of FS-207, an investigational oral tablet, in patients with advanced solid tumors that are microsatellite instability-high, also called MSI-H.
- Trial name
- NCT07593144
- Testing
- FS-207
- Where
- 17 sites in China
- Volunteers
- 156 people
- Sponsor
- Foresight Therapeutics (Hefei) Co., Ltd.
Neoplasm Metastasis
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
- Trial name
- NCT04458259
- Testing
- PF-07265807, Sasanlimab, Axitinib
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 88 people
- Sponsor
- Pfizer
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.
Neoplasms, Rectal
A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have…
- Trial name
- China AZUR-1 (NCT06640049)
- Testing
- Dostarlimab
- Where
- 9 sites in China
- Volunteers
- 23 people
- Sponsor
- GlaxoSmithKline
Advanced Solid Tumor
A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.
- Trial name
- NCT05879822
- Testing
- INCB099280
- Where
- 54 sites in Brazil, China and 7 more
- Volunteers
- 73 people
- Sponsor
- Incyte Corporation
Advanced Solid Tumor, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
- Conditions
- Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma
- Trial name
- NCT04242199
- Testing
- INCB099280
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 182 people
- Sponsor
- Incyte Corporation
Neoplasms, Colorectal, Solid Tumor
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat.
- Conditions
- Neoplasms, Colorectal, Solid Tumor, Colon Cancer, Rectal Cancer
- Trial name
- SYLVER (NCT06710847)
- Testing
- GSK4418959, PD-1 inhibitor
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 14 people
- Sponsor
- GlaxoSmithKline
Non-Small Cell Lung Cancer, Small Cell Lung Cancer
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors.
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Urothelial Carcinoma, Head and Neck Squamous Cell Carcinoma
- Trial name
- NCT03228667
- Testing
- N-803 + Pembrolizumab, N-803 + Nivolumab, N-803 + Atezolizumab
- Where
- 35 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
Metastatic Colorectal Cancer
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: is metastatic (spread to other parts of the…
- Trial name
- SEAMARK (NCT05217446)
- Testing
- Encorafenib, Cetuximab, Pembrolizumab
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 108 people
- Sponsor
- Pfizer
Non Small Cell Lung Cancer, Hepatocellular Carcinoma
Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types
This is a Phase 1, open-label, dose escalation and expansion study of MT-8421 (an Engineered Toxin Body (ETB)) as monotherapy and in combination with nivolumab in patients with selected advanced solid cancer types.
- Conditions
- Non Small Cell Lung Cancer, Hepatocellular Carcinoma, Melanoma, Renal Cell Carcinoma
- Trial name
- NCT06034860
- Testing
- MT-8421, Nivolumab
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Molecular Templates, Inc.
MSI-H/dMMR Solid Tumors
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high…
- Trial name
- NCT03736889
- Testing
- Tislelizumab (BGB-A317)
- Where
- 29 sites in China
- Volunteers
- 200 people
- Sponsor
- BeiGene
Colorectal Cancer Metastatic, Triple Negative Breast Cancer
A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors
This study is being conducted to assess the safety, tolerability, and efficacy of EDP1503 alone and in combination with pembrolizumab in patients with advanced metastatic colorectal carcinoma, triple-negative breast cancer, and…
- Conditions
- Colorectal Cancer Metastatic, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Bladder Cancer
- Trial name
- NCT03775850
- Testing
- EDP1503, Pembrolizumab
- Where
- 8 sites in United States, Canada
- Volunteers
- 69 people
- Sponsor
- Evelo Biosciences, Inc.