45 results
Primary study aim:To determine the efficacy, in terms of the meadian progression-free survival, in patients with recurrent or metastatic endometrial cancer (including carcinosarcoma of the endometrium) receiving treatment with durvalumab and…
Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…
Primary ObjectiveTo assess the tolerability and safety of single ascending oral doses of PHA-022121 administered after a standard meal and of a single 40 mg dose under fasted conditions in healthy adult subjects.To assess the PK characteristics of…
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
The objective of this study is to investigate whether subjects who have taken esketamine, will be able to drive a car as soon as their cognitive function has been restored. The residual effects on driving performance will be compared to placebo.…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…
Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
• to assess the pathologic response to durva and RT • to assess the safety of combining durva and RT
This study is being conducted to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant…
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Primary objectives:To identify and quantify the excretion pathways of oral ASTX029, including the mass balance and the excretions in urine and feces (Period 1).To determine the absolute oral bioavailability (F) of ASTX029 under fasting conditions (…
Primary objective: To evaluate the safety and tolerability of single ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.Secondary objective: To evaluate OMN6 PK in plasma following single ascending i.v. doses in healthy young…
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…
Primary Objective:- Number of participants with dose limiting toxicity - Number of participants with treatment-related adverse events - Number of participants with treatment-emergent adverse events- Number of participants with changes in vital signs…
Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…
This study will evaluate the efficacy and safety of consolidation maintenance treatment consisting of atezolizumab and tiragolumab compared with durvalumab in patients with locally advanced, unresectable Stage III NSCLC who have received at least…
(1) Main objective:Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatinMain Study: To compare the efficacy of durvalumab +…
The research hypothesis for this study is that concurrent durvalumab plus SoC chemotherapy will be more effective than placebo plus SoC chemotherapy for the treatment of MRD+ patients who have undergone complete resection of stage II-III NSCLC when…
Primary:• 3 year recurrence free survival (RFS), in patients with MMRd HREC Secondary:• RFS (median and at 5 years)• OS (median, 3yr, 5yr)• Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year)• Disease-specific…
The overall objectives of this study are to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC who are selected according to biomarker status as identified by tissue-based testing.…