Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Prostatic Neoplasms

Carcinoma, Squamous Cell

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Salivary Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Uterine Neoplasms

Uterine Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Oral Cancer

3: OPB-111001, orally, 2 - 3 times per week

4: OPB-111001, orally, 2 - 3 times per week

OPB-111001

Johann De Bono, Prof. Dr.

Sarah Blagden, Dr.

The purpose of this study is to determine the tolerability profile of OPB-111001 and to determine the most suitable dose of OPB-111001 in patients with advanced cancer

A Clinical Trial to Determine the Most Suitable Dose of OPB-111001 in Patients With Advanced Cancer

A Two-part Phase 1/2a, Open-label, Dose Escalation Study to Evaluate the Tolerability and Preliminary Antitumour Activity of OPB-111001 in Patients With Advanced Cancers That Are Poorly Responsive to Standard Anticancer Treatment

Frequent sampling during Cycle 1 to 3, D1 only from Cycle 4 onwards

Otsuka Novel Products GmbH

Infections

Symptoms and General Pathology

Digestive System Diseases

Communicable Diseases

Vaginal Neoplasms

Virus Diseases

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Vaginal Diseases

Chronic Graft Versus Host Disease

Vaginal Cancer

Penile Cancer

Anal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Avelumab

Valproic Acid

Antineoplastic Agents, Immunological

Enzyme Inhibitors

Neurotransmitter Agents

Valproic Acid (VPA, 12.5 mg/kg) once per day and Avelumab (10 mg/kg IV) every 2 weeks for up to 2 years.

The target serum level for VPA will be between 75 and 100 mcg/mL checked every 2 weeks for the first 6 cycles.

John Walker, MD PhD FRCPC

Up to 20% of all cancers may be associated with a bacterial or viral infection. In some instances, the infection may be one of the reasons why the cancer developed in the first place. One such example is infection with the human papilloma virus (HPV) and the development of cervical or oral cavity cancer.

A viral infection that is chronic may not cause a person symptoms, and may be able to escape detection by a person's own immune system. One of the medications being studied in this clinical trial (Valproic acid) may be able to unmask a chronic viral infection from a person's own immune system, therefore making the virus susceptible to attack by the immune system. In this study Valproic acid is being combined with an immune therapy, Avelumab. Avelumab is an antibody that targets a person's own immune cells, or lymphocytes. Lymphocytes must be activated to fight infections or cancer, but after activation they are deactivated. Avelumab prevents the deactivation of a lymphocyte, in effect "turning off the off-switch." This leads to a re-energizing of a person's immune system, hopefully leading to an attack by the immune system on a person's cancer.

Avelumab is known to be an effective treatment for a variety of cancers, although it has not yet been tested in all cancers. By combining Valproic acid, a treatment which targets the virus that contributed to the development of this type of cancer with Avelumab the investigators hope to enhance the ability of Avelumab to restore the body's own immune defense against the cancer.

Avelumab With Valproic Acid in Virus-associated Cancer

The LATENT Trial: Lytic Activation To Enhance Neoantigen-directed Therapy A Study to Evaluate the Feasibility and Efficacy of the Combined Use of Avelumab With Valproic Acid for the Treatment of Virus-associated Cancer

• Assessment of the clinical response rate according to the immune-related RECIST criteria (iRECIST)

• Feasibility analysis, defined as the proportion of subjects who complete 4 doses of Avelumab in combination with VPA over the total duration of the study.

defined as the time from the date of enrollment to the date of death, whatever the cause.

Progression free survival is defined as the time between the date of treatment initiation and the date of disease progression or death (whatever the cause), whichever occurs first.

• Incidence of adverse events (assessed as the incidence and severity of adverse events, including immune-related adverse events, and the number of discontinuations due to adverse events).

EMD Serono

AHS Cancer Control Alberta

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Adenocarcinoma

Stomach Neoplasms

Lung Neoplasms

Vulvar Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Vulvar Diseases

Small Cell Lung Cancer

Stomach Cancer

Vulvar Cancer

Micronutrients

Pharmaceutical Solutions

Hematinics

Vitamins

Leucovorin

Fluorouracil

Irinotecan

Niraparib

Levoleucovorin

Folic Acid

Vitamin B Complex

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Poly(ADP-ribose) Polymerase Inhibitors

Folinic Acid

Folate

Vitamin B9

Dose escalation of PEN-866 Sodium administered intravenously

Dose escalation of intravenous administration of PEN-866 Sodium in combination with fluorouracil and folinic acid

Intravenously administered PEN-866 Sodium at the Recommended Phase 2 Dose

Dose escalation of intravenous administration of PEN-866 Sodium in combination with niraparib

PEN-866 Sodium is a miniaturized conjugate that comprises an HSP90 targeting ligand linked to SN-38, the active metabolite of irinotecan. PEN-866 is available as a sterile lyophilized powder for solution for infusion.

PEN-866 Sodium

fluorouracil

Folinic acid

Tarveda Clinical Information Center

Anish Thomas, MD

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent).

Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy.

Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies.

PEN-866 in Patients With Advanced Solid Malignancies

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies

The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) will be determined by assessing the incidence of DLTs and treatment related adverse events of PEN-866 as a single agent (Phase 1a) or in combination therapy (Phase 1b).

Safety and tolerability will be determined by assessing the incidence of treatment related adverse events.

Efficacy of PEN-866 in patients with SCLC will be assessed using best overall tumor response rate defined as complete response (CR) or partial response (PR) according to RECIST 1.1.

Efficacy of PEN-866 in patients with gastric or GEJ adenocarcinoma will be assessed using best overall tumor response rate defined as CR or PR according to RECIST 1.1.

Efficacy of PEN-866 in patients with pancreatic adenocarcinoma will be assessed using DCR defined as a best response of CR, PR, or stable disease (SD) according to RECIST 1.1.

Efficacy of PEN-866 in patients with endometrial adenocarcinoma will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.

Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.

Characterize the pharmacokinetic properties of PEN-866 and its components (HSP90 targeting ligand and SN-38)

PK parameters (CMax, AUC) will be evaluated in plasma by standard non-compartmental methods (compartmental modeling may be performed if appropriate).

Size of tumors by CT or MRI using tumor response criteria according to RECIST 1.1 and duration of response.

Efficacy of PEN-866 in combination therapy will be assessed using DCR as defined as CR, PR, or SD according to RECIST 1.1.

Efficacy of PEN-866 in SCLC, gastric or gastroesophageal junction adenocarcinoma, endometrial adenocarcinoma, and squamous cell carcinoma of the genitalia (anus, cervix, vulva, and penis) will be assessed using DCR as defined as CR, PR, or SD according to RECIST 1.1.

Efficacy of PEN-866 in pancreatic adenocarcinoma using best overall tumor response rate as defined as CR or PR according to RECIST 1.1

Time from first documented response (CR or PR) to date of first documented disease progression or death due to underlying cancer.

Time from first PEN-866 dose to date of first documented progression or date of death from any cause, whichever came first

Time from first PEN-866 dose to date of death from any cause

Tarveda Therapeutics

CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.

CIGB300

They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.

Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application

Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation

Laboratorio Elea Phoenix S.A.

Blood and Lymph Conditions

Immune System Diseases

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Lymphoma, Large B-Cell, Diffuse

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Renal Cell

Lymphoma

Hodgkin Disease

Lymphoma, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Transitional Cell Carcinoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Renal Cell Carcinoma

Lymphosarcoma

Clear Cell Renal Cell Carcinoma

Hodgkin Lymphoma

Intravenous administration; Two possible dosing schedules for SL-279252 may be evaluated

The investigational product (IP), SL-279252, is a first-in-class agonist redirected checkpoint (ARC) fusion protein (FP) consisting of the extracellular domains of human programmed cell death 1 (PD- 1) and OX40L, linked by a central Fc domain (PD1-Fc-OX40L).

SL-279252

Shattuck Labs

This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.

This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas. The study design consists of Dose Escalation and Dose Expansion Cohorts. In the dose escalation phase of the study, subjects will be enrolled into sequential dose levels. During dose escalation, two possible schedules for administration of SL-279252 may be explored. The MTD or MAD may be determined for either schedule. Based on accumulating data from the dose escalation phase, including safety, PK, pharmacodynamic and anti-tumor activity, up to two dose expansion cohorts may be opened. The primary objective of the expansion phase is to further refine the safety and tolerability of SL-279252. The expansion cohorts will evaluate one or two doses of SL-279252 using one selected schedule. At the end of dose escalation and dose expansion, safety, PK, anti-tumor activity, and pharmacodynamic data will be reviewed to identify the RP2D.

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas

Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects With Advanced Solid Tumors or Lymphomas

Incidence of all treatment emergent adverse events

Defined based on the rate of dose limiting toxicities (DLTs)

Establish the recommended phase 2 dose of SL-279252

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial to Determine the Most Suitable Dose of OPB-111001 in Patients With Advanced Cancer	NCT02042885	Prostate Cancer Salivary Gland ... Endometrial Can... Squamous Cell C... Breast Cancer Ovarian Cancer	OPB-111001	18 Years -	Otsuka Novel Products GmbH
Avelumab With Valproic Acid in Virus-associated Cancer	NCT03357757	Cancer That is ... p16 Positive SC... Squamous Cell C... p16 Positive Sq... p16 Positive Sq... p16 Positive Sq... EBER Positive N... EBER Positive H...	Valproic Acid Avelumab	18 Years -	AHS Cancer Control Alberta
PEN-866 in Patients With Advanced Solid Malignancies	NCT03221400	Carcinoma Endometrial Ade... Neoplasms Squamous Cell C... Adenocarcinoma ... Advanced Cancer Solid Tumor Solid Carcinoma Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Gastric Cancer Gastric Adenoca... Gastroesophagea... Small-cell Lung... Small Cell Lung... Pancreatic Duct... Pancreatic Aden...	PEN-866 Sodium fluorouracil Folinic acid Niraparib	18 Years -	Tarveda Therapeutics
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application	NCT01639625	Squamous Cell C... Adenocarcinoma ...	CIGB300	21 Years - 70 Years	Laboratorio Elea Phoenix S.A.
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application	NCT01639625	Squamous Cell C... Adenocarcinoma ...	CIGB300	21 Years - 70 Years	Laboratorio Elea Phoenix S.A.
Avelumab With Valproic Acid in Virus-associated Cancer	NCT03357757	Cancer That is ... p16 Positive SC... Squamous Cell C... p16 Positive Sq... p16 Positive Sq... p16 Positive Sq... EBER Positive N... EBER Positive H...	Valproic Acid Avelumab	18 Years -	AHS Cancer Control Alberta
SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas	NCT03894618	Squamous Cell C... Melanoma Non Small Cell ... Urothelial Carc... Gastric Adenoca... Gastroesophagea... Squamous Cell C... Squamous Cell C... Squamous Cell C... Renal Cell Carc... Hodgkin Lymphom... Diffuse Large B... Mismatch Repair...	SL-279252	18 Years -	Shattuck Labs, Inc.

Spots Global Cancer Trial Database for squamous cell carcinoma of the cervix