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

Death

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Nivolumab

Antibodies, Monoclonal

Immunoglobulin G

Complement System Proteins

Immunoglobulins, Intravenous

DS-8273a

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patient groups (cohorts) will receive a single dose level of DS 8273a \& Nivolumab; DS 8273a will be increased in subsequent cohorts.

* Starting Dose: 4 mg/ kg IVQ 3 weeks (Cohort 1)
* Dose Escalation: 8 mg/kg IV Q 3 weeks (Cohort 2), 16 mg/kg IV Q 3 weeks (Cohort 3), 24 mg/kg IV Q 3 weeks (Cohort 4), 2 mg/kg IV Q 3 weeks (Cohort -1), 4 mg/kg IV Q 3 weeks (Cohort -2)

Jeffrey Weber, MD, PhD

The purpose of this study is to evaluate the safety profile, tolerability, and immunoregulatory (pharmacodynamic; PD) activity of DS-8273a administered in combination with nivolumab (anti-PD-1 antibody) to subjects with unresectable Stage III or Stage IV melanoma.

Principal investigator hypothesize that TRAIL D5 antibody DS-8273a administered in combination with nivolumab will be well tolerated and that the addition of DS-8273a will augment the clinical efficacy of nivolumab.

Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma

A Phase 1 Study of TRAIL-DR5 Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Unresectable Stage III or Stage IV Melanoma

Safety will be evaluated for all treated subjects using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Tumor response will be determined for all subjects by RECIST 1.1 as well as by immune-related response criteria

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
Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma	NCT02983006	Melanoma	DS-8273a Nivolumab	18 Years -	NYU Langone Health
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
Study of INBRX-109 in Conventional Chondrosarcoma	NCT04950075	Conventional Ch...	INBRX-109 Placebo	18 Years - 85 Years	Inhibrx Biosciences, Inc
Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma	NCT02983006	Melanoma	DS-8273a Nivolumab	18 Years -	NYU Langone Health

Spots Global Cancer Trial Database for dr5

Every month we try and update this database with for dr5 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dr5

Every month we try and update this database with for dr5 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dr5 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.