TT125-802

Silvio Costanzo, MSc

Elena Garralda, MD

Irene Braña, MD

Valentina Boni, MD

Ilaria Colombo, MD

Krisztian Homicsko, MD

The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.

The purpose of this Phase 1, First-in-Human, Open-label Study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TT125-802 as single agent in subjects with advanced solid tumors.

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

TOLREMO therapeutics AG

Patients of any age, including males and females, who are being treated in the Department of Pediatrics and are already scheduled to undergo MRI

Briefly, new MRI sequences will be used on a patient who is undergoing a scheduled, clinically necessary MRI exam. Any new research sequence will be scanned in addition to the clinically required sequences and will not interfere with the clinical scan other than requiring five to ten minutes of additional "table time". There will be no invasive measures under this protocol.

Gerald Behr, MD

Jose Ricardo Otazo Torres, PhD

This study is being done to see how we can prevent problems caused by movement during the MRI scan. Different ways of doing the scan (techniques) will be tested to see if they are practical and can prevent problems related to motion. For example, changes in the timing of the magnetic field and the radio waves will be examined, and at changes in the way a computer is used to process the images. The new techniques will be compared with the techniques that are usually used.

New Ways of Doing Magnetic Resonance Imaging in Children and Adults

New Image Techniques for Magnetic Resonance Imaging in Children and Adults

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

To assess the new MRI sequences or MRI analysis methods and compare their image quality to current clinical ones. Specifically, we aim to compare the routine sequences with the experimental sequences.

Memorial Sloan Kettering Cancer Center

Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

All Drugs and Chemicals

Vaccines

10 patients with experimental injection at 1.0 mg

2 patients with experimental injection at 1.0 mg

10 patients with experimental injection at 3.0 mg

2 patients with experimental injection at 3.0 mg

patient receive 3 injections of vaccine at the same level dose

HPVDC injection level dose 1

placebo injection level dose 1

HPVDC injection level dose 2

placebo injection level dose 2

Philippe GORPHE, PhD

Caroline EVEN, Dr

Philippe GORPHE, Dr

This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy.

The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored

* 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC
* 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.

This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy.

The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored

* 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC
* 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations. Within each group, patients will be randomized between poly-ICLC- adjuvanted CD40HVac or placebo in a 5:1 ratio.

  12 patients will be treated at each dose level (10 with vaccine and 2 with placebo).

The patients will receive three subcutaneous injections of a poly-ICLC- adjuvanted CD40HVac or placebo:

* The first injection will occur at week 0
* The second injection will occur at week 4 (±7 days)
* The third injection will occur at week 24 (±7 days) Within each dose group, a period of 7 days must be observed between the first administration of vaccine of the first patient of the group and the first administration of vaccine/placebo of the second patient of the group.

A safety monitoring is planned in each dose level group:

* If a grade 5 AE occurs (except if related to cancer) at any time, all vaccinations will be halted, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation
* If a grade 4 AE related to vaccine occurs at any time, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation
* If a grade 3 AE related to vaccine occurs at any time and does not resolve or decrease to grade 1 or baseline after 7 days, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation The IDSMB recommendations as to whether or not to continue the trial after its assessment of the AE will be transmitted to the Steering Committee and to the sponsor.

Enrolment into the second dose group will open depending on the safety data of the first dose group during the safety observation period and after IDSMB and Steering Committee validation. For each patient, this safety observation period begins from the first administration and stops 2 weeks after the second injection, i.e. at Week 6.

Within each group, patients will be randomized between poly-ICLC- adjuvanted CD40HVac or placebo in a 5:1 ratio.

12 patients will be treated at each dose level (10 with vaccine and 2 with placebo).

The patients will receive three subcutaneous injections of a poly-ICLC- adjuvanted CD40HVac or placebo:

* The first injection will occur at week 0
* The second injection will occur at week 4 (±7 days)
* The third injection will occur at week 24 (±7 days)

Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer

Multicentric Randomized Phase I/IIa Trial of the Safety and Immunogenicity of a Therapeutic Anti-HPV DC Targeting Vaccine in Patients With Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

The primary immunological outcomes is: The frequency (%) of HPV16-specific T cells will be evaluated using Activation Induced Marker (AIM) assay using CD69 and CD137 (4-1BB) activation markers after a 24 hours stimulation using two validated tests routinely used in vaccine studies including ICS and AIM assays. These tests will be performed in all collected samples at W0, W2, W6, W26 and W48 for the durability of the responses.

The recommended phase 2 dose (RP2D) of poly-ICLC-adjuvanted CD40HVac will be determined by the Extensive Steering Committee according to the safety analysis and to the capacity of the vaccine to elicit immune responses. The capacity to elicit immune response will be used to choose the RP2D in the event that several doses of vaccine are acceptable in terms of safety (i.e. that meet of the "go-criterion").

LinKinVax

Gustave Roussy, Cancer Campus, Grand Paris

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Lenalidomide

Daratumumab

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

ANV419 administered by intravenous (IV) infusion

ANV419

Lenalidomide and dexamethasone administered orally

Lenalidomide with low-dose dexamethasone

Daratumumab administered by subcutaneous injection

Eduard Gasal, MD

The purpose of this study is to evaluate the safety and tolerability of ANV419 monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab.

The purpose of this multi-site, open-label, Phase 1 adaptive design study is to evaluate the safety, tolerability and preliminary efficacy of ANV419 as a monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab in patients aged 18 years or older with with relapsed or refractory Multiple Myeloma.

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)

Anaveon AG

Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

10 acupuncture sessions of 30 minutes each, twice a week

Acupuncture

Orientation group

Rebeca B Cecatto, PhD

This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms as well as functional impairment and quality of life of patients with chemotherapy induced peripheral neuropathy

The trial is a clinical, single-center, randomized trial study that will involve 30 adult cancer patients with chemotherapy-induced peripheral neuropathy randomized into two groups (control and acupuncture treated with 10 sessions, 2X per week). Both CIPN patients groups will be submitted to a complete physical examination and to clinical assessments with National Cancer Institute Common Terminology Criteria for Adverse Events Scale Version 2.0, Functional Independence Measure Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Scale and Visual Analogue Scale for pain before treatment and in 5 weeks of follow-up after treatment.

The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).

This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms of patients with chemotherapy induced peripheral neuropathy

This study aims to determine the effectiveness of the use of acupuncture in relieving functional impairments of patients with chemotherapy induced peripheral neuropathy

This study aims to determine the influence of the use of acupuncture in quality of life of patients with chemotherapy induced peripheral neuropathy

University of Sao Paulo

Rebeca Boltes Cecatto

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Ipilimumab administered by intravenous (IV) infusion

Claudia Schusterbauer, MD

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.

The purpose of this First-in-Human, open-label, dose escalation study is to assess the initial safety and efficacy profile of ANV419 intravenous infusion alone and in combination with ipilimumab in patients with advanced solid tumours. It will evaluate the safety and tolerability of ANV419 alone and in combination with ipilimumab and, the safest and best dose of ANV419 when used alone or in combination.

A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer.

ANV419 First in Human Study Phase 1: Open-label, Dose Escalation Study of ANV419 as Single Agent and in Combination With Ipilimumab in Patients With Relapsed/Refractory Advanced Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors	NCT06403436	Advanced Solid ... Adult Solid Tum... Adult Disease Cancer	TT125-802	18 Years -	TOLREMO therapeutics AG
New Ways of Doing Magnetic Resonance Imaging in Children and Adults	NCT04643015	Pediatric Disor... Adult Disease	MRI	-	Memorial Sloan Kettering Cancer Center
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer	NCT06007092	Head and Neck C... Adult Disease	HPVDC injection... placebo injecti... HPVDC injection... placebo injecti...	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors	NCT06403436	Advanced Solid ... Adult Solid Tum... Adult Disease Cancer	TT125-802	18 Years -	TOLREMO therapeutics AG
A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)	NCT05641324	Multiple Myelom... Relapsed Cancer Refractory Mult... Adult Disease Hematologic Dis...	ANV419 Lenalidomide wi... Daratumumab	18 Years -	Anaveon AG
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).	NCT02309164	Neoplasm Adult Disease Neuropathy	Acupuncture Orientation gro...	18 Years -	University of Sao Paulo
A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer.	NCT04855929	Advanced Solid ... Adult Disease Lung Cancer	ANV419 Ipilimumab	18 Years -	Anaveon AG
A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer.	NCT04855929	Advanced Solid ... Adult Disease Lung Cancer	ANV419 Ipilimumab	18 Years -	Anaveon AG
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer	NCT06007092	Head and Neck C... Adult Disease	HPVDC injection... placebo injecti... HPVDC injection... placebo injecti...	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris

Spots Global Cancer Trial Database for adult disease