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Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a randomized phase II clinical trial

to compare the short-term toxicity of the conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week Overall Treatment Time (OTT) to 14 x 3 Gy, once daily fractionation in a three-week OTT, with respect to the rate of postoperative…

Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Advanced Solid Tumors

The ability to fuse discrete small molecules with different types of pharmacologic activity has created remarkable opportunities in drug discovery and development. Bendamustine itself is a fusion molecule of the nitrogen mustard mechlorethamine and…

A Phase 1 Study of MK-5890 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…

Phase 1/2 dose escalation and cohort expansion study evaluating MCLA-158 (Petosemtamab) as single agent or in combination in advanced solid tumors

This study has been transitioned to CTIS with ID 2024-513627-16-01 check the CTIS register for the current data. Dose escalationPrimary• To determine the RP2D of single-agent petosemtamab in mCRC patients who have progressed on chemotherapy, with or…

HYpofractionated, Dose-redistributed RAdiotherapy with protons and photons to combat radiation-induced immunosuppression in head and neck squamous cell carcinoma

The objectives of this study are to determine the safety of HYDRA with protons and photons by conducting two parallel phase-I trials. HYDRA*s efficacy will be compared to standard of care (SOC). The immune effects of HYDRA-protons will be evaluated…

Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitors

Primary: To determine the pharmacokinetics of several clinically used targeted anti-cancer agents.Secondary: To examine the relationship between treatment response/toxicity and plasma (or intracellular) drug levels.To evaluate the specific influence…

A Phase 1 first- in-human dose escalation and expansion study for the evaluation of safety,
pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR441000 administered intratumorally as monotherapy and in combination with cemiplimab in patients with advanced solid tumors

Primary Objectives: Dose Escalation (SAR441000 Monotherapy): -To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the overall safety and tolerability profile of SAR441000 when administered intratumorally as…

A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Tumors

This study has been transitioned to CTIS with ID 2024-513625-23-00 check the CTIS register for the current data. Primary objectives:•To determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RPTD) of ABBV-155 administered as…

A Phase I/II Combination Study of NMS-03305293 and Temozolomide in Adult Patients with Recurrent Glioblastoma

This study has been transitioned to CTIS with ID 2023-508318-41-00 check the CTIS register for the current data. Primary Objective:• To determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination…

A PHASE Ia/Ib DOSE-ESCALATION AND DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-6036 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATION

This study has been transitioned to CTIS with ID 2023-506311-18-00 check the CTIS register for the current data. This Phase Ia/Ib study will evaluate the safety, pharmacokinetics, immunogenicity (as applicable for study biotherapeutics), preliminary…

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor (INTERLINK-1)

The study will compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of Overall Survival in HPV-unrelated participants. The formal statistical analysis will be performed to test the following…

*Predictive value of Diffusion weighted MRI in patients with HNSCC treated by (chemo)radiotherapy (PREDICT study)*

To determine the prognostic value of diffusion-weighted MRI and circulating tumor DNA (ctDNA) performed pre-treatment and during treatment in predicting the locoregional response to (chemo)radiation for HNSCC.

The AIM-HN and SEQ-HN Study: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)

Primary Objective: • To determine the objective response rate (ORR) of tipifarnib in subjects with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS mutations with a VAF>=20% (High VAF population), as assessed by Independent Review…

SPLASH: Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using 177Lu-
PNT2002 PSMA Therapy After Second-line Hormonal Treatment

This study has been transitioned to CTIS with ID 2024-515604-39-00 check the CTIS register for the current data. The purpose of this research study is to learn about the safety and effectiveness of 177Lu-PNT2002, an investigational agent being…

A Phase 1/2 Study of the Oral TRK Inhibitor larotrectinib in Pediatric patients with Advanced Solid or Primary Central Nervous System Tumors

This study has been transitioned to CTIS with ID 2022-502668-20-00 check the CTIS register for the current data. PHASE 1 OBJECTIVES:Primary:To determine the safety of oral larotrectinib , including dose-limiting toxicity (DLT), in pediatric patients…

An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

This study has been transitioned to CTIS with ID 2023-503905-12-00 check the CTIS register for the current data. The main objectives for this study are: - To assess the safety and tolerability of the combination of pembrolizumab and lenvatinib and…

A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors (eNRGy)

This study has been transitioned to CTIS with ID 2024-512358-78-00 check the CTIS register for the current data. Part 1 of the trial (already completed):The primary objective of the research concerned the determination of the Maximum Tolerated Dose…

Pharmacokinetics of cytostatic agents and tyrosine kinase inhibitors in pediatric oncology

To assess the pharmacokinetics of various cytotoxic agents (carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, doxorubicin, etoposide, methotrexate and vincristine) and tyrosine kinase inhibitors (ALK inhibitors, MEK inhibitors, BCR-ABL…

INFORM2 exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies

This study has been transitioned to CTIS with ID 2024-514409-78-01 check the CTIS register for the current data. Primary objectivePhase I (Phase I of the younger cohort was concluded in May 2023): To determine the recommended phase II dose (RP2D) of…

A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients with Advanced Malignancies

Escalation PhasePrimary ObjectivesThe primary objectives of this study are to:• Determine the safety and tolerability of oral DCC-2618• Determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral DCC-261Secondary…