Browse
Submit Data
Databases
API
Help

Dataset Information

20 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

ABSTRACT: This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

DISEASE(S): Non-small-cell Lung, Carcinoma,Colorectal,Lung Cancer,Carcinoma,Kras G12c Mutant Solid Tumors,Pulmonary Neoplasms,Colorectal Cancer,Advanced Cancer,Cancer Of The Lung,Advanced Solid Tumors Harboring The Kras G12c Mutation,Lung Neoplasms,Neoplasms,Carcinoma, Colorectal,Kras G12c Mutant Solid Tumors, Carcinoma,Kras G12c,Pulmonary Cancer,Colorectal Neoplasms,Neoplasms, Pulmonary,Cancer Of Lung,Carcinoma, Non-small-cell Lung,Neoplasms, Lung

PROVIDER: 2363112 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation

Project description:A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.

| 2743980 | ecrin-mdr-crc

A Study of Safety and Efficacy of KFA115 Alone and KFA115 in Combination With Tislelizumab in Patients With Select Advanced Cancers

Project description:The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with tislelizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.

| 2748708 | ecrin-mdr-crc

First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation

Project description:The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JNJ-74699157 in participants with advanced solid tumors harboring a kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation (Part 1: Dose escalation) and to determine the safety and preliminary antitumor activity of JNJ-74699157 at the RP2D regimen in participants with advanced solid tumors harboring a KRAS G12C mutation (Part 2: Dose expansion).

| 2309880 | ecrin-mdr-crc

Phase 1 trial of durvalumab (anti-PD-L1) in combination with lenalidomide in relapsed/refractory cutaneous T cell lymphoma

Project description:T cells in cutaneous T-cell lymphoma (CTCL) are functionally exhausted, expressing immune inhibitory molecules such as PD1 and PD-L1. Durvalumab selectively targets PD-L1 on exhausted T cells and distinct cells within the CTCL tumor microenvironment (TME) and may restore an anti-tumor immune response. The oral immunomodulator lenalidomide, which has shown activity in CTCL, may enhance immune checkpoint blockade by durvalumab. We initiated a phase 1/2 clinical trial of lenalidomide and durvalumab in patients with refractory/advanced CTCL (NCT03011814). Primary objectives were to assess safety and tolerability and identify the maximum tolerated dose/recommended phase 2 dose. Secondary and tertiary objectives were to investigate efficacy and the effects on the TME. Thirteen patients enrolled in sequential cohorts received fixed dose durvalumab and dose escalation of lenalidomide. Thirteen patients were evaluable for toxicities and 12 for response in phase 1. No serious adverse events (AEs) or dose-limiting toxicities (DLTs) were observed during cycles 1-3 (DLT evaluation period). The most frequent AEs were tumor flare, fatigue, neutropenia and leukopenia. Three patients developed grade 1/2 autoimmune thyroiditis that resolved with treatment. Median cycles of treatment were 11 (range, 3-42+). Median duration of response was 25.5 (range 8-36.5) months. Anti-PD-L1/lenalidomide showed clinical activity; there were 7 partial responses, 4 stable disease and 1 progressive disease. Adaptive and innate immune signatures potentially predictive of response seen in gene expression profiling of serial skin samples were downregulation of TNF-alpha signaling via NFκB, IFN-gamma, and PI3-AKT-mTOR signaling pathways in responders vs up-regulation of MYC targets and pro-inflammatory pathways in non-responders. Profiling of immune cell compositions revealed changes in individual immune cell clusters based on treatment status and response.

2024-07-11 | GSE271668 | GEO

A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy

Project description:The purpose of the study is to assess the safety and tolerability of GC1118 in combination with irinotecan or FOLFIRI in order to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D)

| 2267516 | ecrin-mdr-crc

A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors

Project description:To assess safety and tolerability, describe the dose-limiting toxicities, assess the preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or metastatic solid tumor malignancies that have received at least 1 prior line of treatment.

| 2294936 | ecrin-mdr-crc

A clinical study of TG6002 and flucytosine in patients with colorectal cancer

Project description:Primary objectives: Phase I:Determination of the maximum tolerated dose (MTD) or maximum feasible dose (MFD) and the recommended dose for the Phase IIa part (RP2D).Phase IIa:Determination of the preliminary efficacy of intrahepatic artery injection of TG6002 in combination with 5-FC. Primary endpoints: Phase I:Dose-limiting toxicities, adverse events, serious adverse events, change in standard laboratory parameters and vital signs.Phase IIa:Disease control rate (DCR).

| 2538646 | ecrin-mdr-crc

A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations

Project description:A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.

| 2398774 | ecrin-mdr-crc

Oxaliplatin combined with melphalan in IHP.

Project description:Primary objectives: Firstly, determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan. Primary endpoints: - Determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan-Determination of phase II doses of oxaliplatin and melphalan.

| 2520710 | ecrin-mdr-crc

A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors

Project description:Phase 1 (Dose Escalation) of this study will assess the safety, tolerability, dose-limiting toxicity (DLT), and will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EU101 in participants with advanced solid tumors. Phase 2 (Dose Expansion) of the study will assess the antitumor effect of EU101 in two indications including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

| 2378840 | ecrin-mdr-crc

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data