22 results
Primary Objective:• To assess the safety and tolerability of 2B3-101 when administered intravenously (IV) as single agent in patients with solid tumors and brain metastases or recurrent malignant glioma in order to determine the Maximum Tolerated…
Primary: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
Assess the feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery
The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…
Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…
Primary objective(s)Phase Ib:-Define the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab in patients with advanced or metastatic HER2-positive breast cancers.Phase II:-Evaluate…
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine iv chemotherapy as treatment in patients with HER2-overexpressing, metastatic breastcancer, who failed one prior trastuzumab treatment.
Primary: To estimate the MTD or RDE and preferred dosing schedule of LJM716 when administered in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer or gastric cancer.Secondary: Safety and tolerability, PK, PD…
Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…
Primary ObjectivesPart A: RO6874281 Dose Escalation as a Single AgentThe primary objectives for this study are as follows:* To describe the safety and tolerability profile of RO6874281 as a single agent* To determine the maximum tolerated dose (MTD…
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
The primary objective is to determine if metastatic breast cancer patients with HER2-negative primary tumors but with at least one HER2-positive CTC benefit from trastuzumab-containing chemotherapy. Secondary objectives are to determine the impact…
Primary objectivesThe primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inbibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line…
Primary objective:- To compare the efficacy of zanidatamab in combination with chemotherapy or in combination with chemotherapy and tislelizumab to the efficacy of trastuzumab in combination with chemotherapy in subjects with unresectable locally…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…
To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
• To evaluate the safety and tolerability of Runimotamab when administered as a single agent (Phase Ia) and in combination with trastuzumab (Phase Ib)• To determine the maximum tolerated dose (MTD), to identify the recommended phase II dose (RP2D),…