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NCT ID: NCT05029882 Recruiting - Colorectal Cancer Clinical Trials

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

Start date: October 13, 2021
Phase: Phase 1
Study type: Interventional

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) [Part 2i] or mutated EGFR-expression (mutEGFR NSCLC) [Part 2ii], squamous NSCLC [Part 2iii], GEA [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion [Part 4], participants MET amplification will receive IV ABBV-400 monotherapy in expansion [Part 5], participants MET mutation will receive IV ABBV-400 monotherapy in expansion [Part 6], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab [Part 7a], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets [Part 7b]. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

NCT ID: NCT05029817 Recruiting - Cystic Fibrosis Clinical Trials

Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters

Start date: July 15, 2021
Phase:
Study type: Observational

The main objective of this study is to assess the ovarian reserve of CF patients via measurement of AMH and AFC. Secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients. Outcomes measured will be levels of AMH and AFC, as compared to standard means in the general population. There is no need for a control group in this study since the standardized means of AMH and AFC in the general population are a more accurate comparable measure, which is based on data collected from large-scale populations, and thus accounts for confounding age factor in a more complete manner than can be obtained via a control group (Almog et al., 2011, La Marca et al., 2012, Penzias et al., 2020).

NCT ID: NCT05029375 Recruiting - Clinical trials for Autism Spectrum Disorder

Parental Insightfulness and the Acquisition of Social Skills in Children With ASD.

ASD
Start date: August 28, 2021
Phase: N/A
Study type: Interventional

Parental Insightfulness (PI), promotes the development of the child's socio-emotional competence and her ability to have productive and sustaining relationships. PI is even more central in the case of young children with ASD, who struggle to socially communicate their needs and their mental and emotional states. PI's effects on the child's peer-interaction have not been tested and Since parents play a central role in intervention programs for their children with ASD, examining modifiable parent factors as mediators and moderators of treatment effectiveness could contribute to this line of research. The proposed study aims to test how pre intervention PI and intervention-related changes in PI affect parents' ability to support their children in the acquisition of peer-interaction skills. Using the PEERS for Preschoolers (P4P) program, the study will examine the effect of PI and parental involvement in a social skills intervention on children's acquisition and maintenance of social skills.

NCT ID: NCT05021835 Recruiting - Inflammation Clinical Trials

ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

ZEUS
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

NCT ID: NCT05019417 Recruiting - Clinical trials for Monocarboxylate Transporter 8 Deficiency

Glycerol-Phenylbutyrate Treatment in Children With MCT Mutation (Allan-Herndon- Dudley Syndrome)

Start date: June 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Thyroid hormone (TH) is crucial for normal brain development. The transporter monocarboxlate transporter 8 (MCT8), located at various organs including brain neurons, is crucial for cellular transport of TH, mainly T3 . A defect in this transporter causes Allan-Herndon-Dudley syndrome (AHDS), which characterized by severe motor and cognitive retardation. Serum TH tests typically show low T4, high T3 and mildly elevated TSH. The neurological phenotype entails diminished TH transport into the brain. On the other hand, elevated serum T3 leads to hypermetabolic status in peripheral tissues. Subsequently, AHDS patients have a low body weight and muscle mass. Currently, no effective treatment is available. Over the last decade, several studies focused on the effect of T3 analogues, that their trans-membrane transport is not mediated by MCT8. Two analogues were studied: Diiodothyropropionic acid (DITPA) and tetraiodothyroacetic acid (Triac). Both agents have demonstrated improvement in serum TH levels (mainly T3 and TSH) but no change in the neurocognitive status of the patients. Recently, several studies have demonstrated that sodium phenylbutyrate (PB) acting as a chaperon and increase the expression of MCT8 in the cell membrane. Subsequently, cells transfected with various mutations in MCT8 have shown remarkable improvement in T3 transport into the cytoplasm. We hypothesize that treatment of AHDS patients with glycerol phenylbutyrate (GPB) will improve thyroid function and neurodevelopmental parameters and relieve symptoms resulting from toxic T3 levels in peripheral tissues. Objective: To test safety and efficacy of PB treatment in AHDS patients. Primary objectives: To determine the effect of PB treatment on serum levels of TH. Secondary objective: 1. To determine the effect of PB on T3-associated hyperthyroid state in peripheral tissues. 2. To determine the effects of PB treatment on the neurodevelopmental status. Study design: therapeutic prospective trial. Study population: Up to 6 AHDS patients with genetically proven ADHD. Intervention: all participants will receive an escalating dose of PB in the form of Glycerol-PB (commercial name Ravicti) until individual serum T3 levels have been normalized or dose limiting toxicities occur. Duration of treatment: 12 months including the wash-out period of 1 month from the current Triac therapy

NCT ID: NCT05011058 Recruiting - Clinical trials for EBV-Positive DLBCL, NOS

An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

NAVAL-1
Start date: May 28, 2021
Phase: Phase 2
Study type: Interventional

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

NCT ID: NCT05009992 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Combination Therapy for the Treatment of Diffuse Midline Gliomas

Start date: October 20, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial determines if the combination of ONC201 with different drugs, panobinostat or paxalisib, is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. ONC201, panobinostat, and paxalisib are all enzyme inhibitors that may stop the growth of tumor cells by clocking some of the enzymes needed for cell growth. This phase II trial assesses different combinations of these drugs for the treatment of DMGs.

NCT ID: NCT05007106 Recruiting - Clinical trials for Hepatocellular Carcinoma

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

Start date: September 16, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

NCT ID: NCT05006794 Recruiting - Solid Malignancies Clinical Trials

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies

Start date: September 15, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase I open-label, multi-center study of GS-9716 tested either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies. Primary objectives are to define the maximum tolerated dose (MTD) or maximum administered dose of GS-9716, and characterize the safety and tolerability of GS-9716 as monotherapy and in combination with anti-cancer therapies.

NCT ID: NCT05006547 Recruiting - Clinical trials for Healthy Participants

Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training

Start date: July 1, 2021
Phase:
Study type: Observational

Proper functioning of the ankle musculature, specifically peroneal muscles, is crucial for maintaining balance and reducing the risk for falls. Evidence suggests that a decrease in aspects of neuromuscular control already starts at midlife (45-65 years). However, there is almost no information regarding the function of the ankle muscles at the middle-age as most experiments have compared young (<35 years) and older subjects (>65 years). Moreover, neuromuscular training can improve the function of ankle muscle in response to perturbation; yet, no previous study has compared the level of effectiveness between middle-aged and young adults.