View clinical trials related to Advanced Solid Tumor.
Filter by:This is a phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of IAH0968 in patients with HER2-positive advanced solid tumors who have failed standard treatment.
Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.
The purpose of this study is to assess the safety and effectiveness of ATRN-119 through the performance of a Phase 1/2a, open-label, safety, PK, and preliminary efficacy study of oral ATRN-119 in patients with advanced solid tumors.
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and atezolizumab combination therapy in patients with advanced solid tumors.
This is a Phase 1/2, multicenter, open label, first in human (FIH) study of DCC-3116 as monotherapy, and in combination with trametinib, binimetinib, or sotorasib in patients with advanced or metastatic solid tumors with RAS/MAPK pathway mutation. The study consists of 2 parts, a dose-escalation phase, and an expansion phase.
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461 on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also evaluate the predictive value of mutational signatures and explore the significance of dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's exploratory cohort.
This is a multicenter, open label, nonrandomized, sequential dose escalation/cohort expansion, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 in subjects with advanced solid tumors and breast cancer. The study will be done in two phases, described below. Phase 1a (Dose Escalation Phase): The Phase 1a portion is designed to determine the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of orally administered BTX-A51. BTX-A51 will be administered once daily on a weekly schedule of 5 days on/2 days off. Dose escalation will proceed according to a modified 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing). A DLT may be observed in no more than 0 out of 3 or 1 out of 6 subjects who have completed the DLT observation period before the next cohort initiates accrual. Barring DLT, sequential dose escalation of BTX-A51 is planned with up to a total of 6 dose levels; on the basis of these an MTD will be identified. The MTD is defined as the highest dose level with a subject incidence of DLTs of 0 or 1 out of 6 during the first 28 days of study drug dosing. A minimum of 6 subjects needs to be treated at a dose level before this dose level can be deemed as the MTD. Phase 1b (Cohort Expansion Phase): Dose expansion may begin when the RP2D has been determined. Up to 40 additional subjects will be enrolled to evaluate safety and preliminary efficacy of BTX-A51 in subjects with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), GATA3 mutant (mt) and wild-type (wt) metastatic breast cancer (mBC). Dosing in this phase of the study consists of the first cycle of therapy (i.e., 28 days).
This clinical development plan for T-1201 will begin with a first-in-human (FIH), open label, multi-center Phase I dose-escalation to evaluate the safety, tolerability, and human pharmacokinetics of T-1201 and determine the maximum tolerated dose (MTD) levels in patients with advanced solid cancer. The further Phase II study will then be designed based on the safety, pharmacokinetics, and preliminary efficacy results from the FIH Phase I study. The initial part of the Phase I study is a safety, tolerability, and pharmacokinetic phase wherein T-1201 Injection will be intravenous administered to patients with advanced solid cancers. The study will be an open label, multi-center Phase I dose-escalation study. Approximately 30-40 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until maximum tolerated dose (MTD) is reached. The modified accelerated titration design will be used for dose escalation. The initial dose regimen will be 18 mg/m 2 of T-1201 Injection once every 4 weeks in 28-day cycles. Doses will escalate in the following sequence: 18, 36, 71, 119, 178 and 249 mg/m 2 of T-1201 Injection. Dose escalation will cease when 2/3 or 2/6 patients experience a DLT, or a dose of 249 mg/m 2 is reached. A DLT must occur within the first cycle (Cycle 1) to determine dose escalation between cohorts. If 2/3 or 2/6 patients experience DLTs at the initial dose level of 18 mg/m 2 , 2 more dose levels lower than 18 mg/m 2 will be added to the study. No human study has been conducted for product T-1201, the benefits/risks of T-1201 is therefore not available at this stage. Since T-1201 is a prodrug of SN-38 with target delivery design, the benefits/risks ratio of T-1201 would thus be expected to be more favorable than irinotecan product (CAMPTOSAR ® , Pfizer).
This is a Phase 1/1b open-label, dose-escalation, and cohort expansion study with BID (tablet) oral dose of MPT-0118 in subjects with advanced or metastatic refractory solid tumors. The study will be conducted in 3 parts: - Part A: MPT-0118 dose-escalation - Part B: MPT-0118 dose-escalation in combination with pembrolizumab - Part C: Cohort expansion of MPT-0118 in combination with pembrolizumab
The purpose of this study is to test the safety and efficacy of ANV419 (single agent) and in combination with ipilimumab in patients with relapsed/refractory advanced solid tumors.