Neoplasms

All Conditions

Digestive System Diseases

Nervous System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Wounds and Injuries

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Sarcoma

Hematoma, Subdural

Mesothelioma

Mesothelioma, Malignant

Sarcoma, Ewing

Chondrosarcoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Adenoma

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Stomach Cancer

Soft Tissue Sarcoma

Malignant Mesothelioma

Ewing Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Herbal and Botanical

Vitamins

Carboplatin

Fluorouracil

Irinotecan

Antibodies

Pemetrexed

Temozolomide

Cisplatin

Immunoglobulins

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Alkylating

Alkylating Agents

Cola

Folinic Acid

Folate

Vitamin B9

INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.

Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)

Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy

Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide

Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy

Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide

INBRX-109

5-fluorouracil

Study Director, -Inhibrx

Anahita Nersiseyan Malhami

New Patient Services Coordinator

Mark Agulnik, MD

Leila Mirtagui

David Berz, MD

Adam Burgoyne, MD

Victoria Chua-Alcala

Sant P Chawla, MD

Trace Dimos

Christopher Lieu, MD

Suzanne Scott

Olatunji Alese, MD

J Glod

Myron Hepner

Rashmi Chugh, MD

Care Advisors

Emily Slotkin, MD

Jessica Grebenc

Dale Shepard, MD

Sarah Tressel

Michael Heinrich, MD

Sarcoma Research

Lee Hartner, MD

Elizabeth Davis, MD

Jihyun Shin

Anna Lui

David Hong, MD

Kayla Grossi

Alexander Spira, MD

Clinical Lead

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Tumor response will be determined by RECISTv1.1.

Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

The MTD and/or RP2D of INBRX-109 will be determined.

Area under the serum concentration time curve (AUC) of INBRX-109 will be determined.

Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.

Maximum observed serum concentration (Cmax) of INBRX-109 will be determined.

Trough observed serum concentration (Cmax) of INBRX-109 will be determined.

Time to Cmax (Tmax) of INBRX-109 will be determined.

Inhibrx Biosciences, Inc

Humanized anti-TWEAK receptor monoclonal IgG1 antibody

PDL192

Mihail Obrocea, MD

This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors.

The primary study objective is to determine the maximum tolerated dose of PDL192 in subjects with advanced solid tumors.

A Trial of PDL192 in Subjects With Advanced Solid Tumors

A Phase 1, Multicenter, Open-Label, Dose Escalation Trial of PDL192 in Subjects With Advanced Solid Tumors

Abbott

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hyperthermia

Fever

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days

ThermalCore Hyperthermia System

Jan Winetz, MD

To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.

This study is a prospective, single-arm phase I trial of 20 ovarian cancer patients to be treated with PISH for 6 cycles, delivered every 28 days. This mimics chemotherapy treatments, in concordance with the fractional cell kill hypothesis of cytotoxic agents.

As this study is for safety, only, metastatic peritoneal or ovarian cancer, of any histology (epithelial, sex-cord stromal, germ cell, or sarcoma) that has progressed after 2 cycles of chemotherapy, and is considered incurable, will be included. All patients must meet performance status and organ function entry criteria. Patients must have first undergone standard first line primary surgery and chemotherapy, and have then gone on to fail second line chemotherapy treatment, (with or without secondary cytoreductive surgeries). Patients must be candidates for, and expecting treatment by, the usual third line chemotherapy agent palliation traditionally offered by medical oncology. Patients may have received treatment beyond third-line therapy, as long as they meet entry requirements for this study.

A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer

Determine the frequency and severity of unexpected serious adverse events

Patients continue to meet the entry criteria for organ toxicity defined in the trial by the time prior to next scheduled treatment at 28 days.

Time To Progression (TTP, defined as the interval from treatment initiation to disease progression) for the cohort. Measurement of Time To Progression (TTP) for the cohort will be conducted using PET CT, CA-125, and physical examination. Progression is defined as radiologic progression RECIST criteria, CA-125 doubling per Gynecologic Intergroup Definition of progression of disease, or any evidence of palpable lesion growth on physical examination.

ThermalCore Inc

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Hematologic Neoplasms

Hodgkin Disease

Lymphoma, T-Cell, Cutaneous

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Hodgkin Lymphoma

Cutaneous T-cell Lymphoma

EDO-S101, IV, 20mg/m2 up to 150mg/m2 Day1 of each 21 day cycle-Stage 1; EDO-S101,IV, 40mg/m2 up to 60mg/m2 on Day 1 and Day 15 of 28 day cycle in multiple myeloma patients and IV, 40mg/m2 up to 100mg/m2 on Day 1 of 21 day cycle in lymphoma patients-Stage 2

Tinostamustine

Pier L Zinzani, MD,PhD

This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.

Tinostamustine is a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule. It is anticipated that tinostamustine may have activity in various hematological malignancies and solid tumors.

The study consists of 2 stages:

* Stage 1: Dose Escalation to determine Maximum Tolerated Dose (MTD) at the optimal infusion time and the pharmacokinetic (PK) profiles; is expected to enroll between 21 and 48 patients. Stage 1 has now been completed.
* Stage 2: Expansion in five Cohorts, in which approximately 12-16 patients will be enrolled per cohort, for a maximum of 70 patients.

In Stage 1, tinostamustine doses were escalated following the standard 3+3 design. The decision to escalate to the next dose level occurred after all cohort patients completed 3 weeks (21 days) of observation and have been evaluated for safety and toxicity.The starting dose was a 1 hour infusion of 20 mg/m2, and the maximum dose level was 150 mg/m2. Reduced infusion times of 45 minutes and 30 minutes were assessed once the maximum tolerated dose at a 1-hour infusion was determined.

In Stage 2, five cohorts of patients (with relapsed/refractory multiple myeloma (MM); relapsed/refractory Hodgkin's lymphoma; relapsed/refractory peripheral T-cell lymphoma (PTCL); relapsed/refractory cutaneous T-cell lymphoma (CTCL); and relapsed/refractory T-cell Prolymphocytic leukemia (T-PLL) will be enrolled and treated at the recommended Phase 2 dose (RP2D) based on results of Stage 1. For MM patients, treatment will occur on Day 1 and Day 15 of a 28 day cycle. For lymphoma patients, treatment will occur on Day 1 of a 21 day cycle. Patients in each stage of the study are expected to receive a median of four Cycles of therapy, and the maximum number of treatment Cycles allowed is 12.

A sub study portion was added to the protocol as an amendment. In the sub study 6 patients will be treated with 100mg/m2 tinostamustine infusion delivered over 100 minutes.

Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

A Phase 1 Trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

relevant patient listing data of de-identified patients may be reviewed

To characterize the effect of tinostamustine at a dose of 100 mg/m2 on cardiac repolarization (QTcF) and other ECG parameters

Determine clinical benefit rate by cohort

Number of participants with treatment-related adverse events as assessed by CTCAE V4.03

Evaluate time to objective response by cohort

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas	NCT03715933	Solid Tumors Malignant Pleur... Gastric Adenoca... Colorectal Aden... Sarcoma Pancreatic Aden... Ewing Sarcoma Chondrosarcoma GIST SDH-deficient S...	INBRX-109 Carboplatin Cisplatin Pemetrexed 5-fluorouracil Irinotecan Temozolomide	12 Years - 85 Years	Inhibrx Biosciences, Inc
A Trial of PDL192 in Subjects With Advanced Solid Tumors	NCT00738764	Cancer	PDL192	18 Years -	Abbott
A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer	NCT02093871	Ovarian Cancer	ThermalCore Hyp...	18 Years - 69 Years	ThermalCore Inc
Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies	NCT02576496	Hematological M... Multiple Myelom... Hodgkin's Lymph... Cutaneous T Cel...	Tinostamustine	18 Years -	Mundipharma Research Limited
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas	NCT03715933	Solid Tumors Malignant Pleur... Gastric Adenoca... Colorectal Aden... Sarcoma Pancreatic Aden... Ewing Sarcoma Chondrosarcoma GIST SDH-deficient S...	INBRX-109 Carboplatin Cisplatin Pemetrexed 5-fluorouracil Irinotecan Temozolomide	12 Years - 85 Years	Inhibrx Biosciences, Inc
A Trial of PDL192 in Subjects With Advanced Solid Tumors	NCT00738764	Cancer	PDL192	18 Years -	Abbott
Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies	NCT02576496	Hematological M... Multiple Myelom... Hodgkin's Lymph... Cutaneous T Cel...	Tinostamustine	18 Years -	Mundipharma Research Limited
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations	NCT01752920	Solid Tumor	Derazantinib lo... Derazantinib mi... Derazantinib hi... Derazantinib at...	18 Years -	Basilea Pharmaceutica

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