Adult Clinical Trials

New Anti-Cancer Drugs (Phase I)

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact the Phase I Clinical Trials Office at 919.684.6342.

19 trials identified.

Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects with Advanced Malignancies
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Denise Morin, RN
Phone: 919.684.6342
Purpose: In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.
Reference Number: 00005540
View this trial at ClinicalTrials.gov

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Michael Morse
Contact: Leslie Lewis, RN
Phone: 919.684.6342
Purpose: ADDENDUM- PLEASE NOTE: AS OF JANUARY 2017, THIS STUDY IS ONLY RECRUITING PATEINTS WITH BLADDER AND PANCREATIC CANCER. To investigate the safety and efficacy of Nivolumab as a single agent or in combination with Ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of Nivolumab with Ipilimumab and Cobimetinib is also investigated in PC.
Reference Number: 00048169
View this trial at ClinicalTrials.gov

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects with Advanced Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: John Strickler
Contact: Leslie Lewis, RN
Phone: 919.684.6342
Purpose: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 in subjects with advanced solid tumors. The early clinical development plan for ABT-165 is based on the activity demonstrated in preclinical models.
Reference Number: 00049036
View this trial at ClinicalTrials.gov

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects with Advanced Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: John Strickler
Contact: Phase I Clinical Trials Office
Phone: 919.684.6342
Reference Number: 00052355

First-in-Human Dose-Escalation Study of TEW-7197 Monotherapy in Subjects with Advanced Stage Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: The phase I dose escalation study will investigate the safety, tolerability, and pharmacokinetics of the TGF-Ã? pathway inhibitor TEW 7197 in subjects with advanced, refractory solid tumors.
Reference Number: 00053834
View this trial at ClinicalTrials.gov

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 7 Ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Phase I Oncology Research Team
Phone: 919.684.6342
Purpose: The purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Reference Number: 00058297
View this trial at ClinicalTrials.gov

A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of INCB24360 Administered in Combination With Nivolumab in Select Advanced Cancers
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Niharika Mettu
Contact: Phase I Oncology Clinical Research Team
Phone: 919.684.6342
Purpose: This is a Phase 1/2, open label study that will be conducted in 2 parts. The first part of the study (Phase 1) will consist of a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas including melanoma (MEL), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), ovarian cancer, and B cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL). The second part (Phase 2) of the study will include expansion cohorts in the tumor types tested in Phase 1 (except diffuse large B-cell lymphoma (DLBCL) will be the only lymphoma permitted and Phase 2 will also include a cohort for glioblastoma) with a) historically good activity with nivolumab monotherapy, and b) with historically low activity with nivolumab monotherapy.
Reference Number: 00058492
View this trial at ClinicalTrials.gov

Modular phase II study to link targeted therapy to patientswith pathway activated tumors: Module 6 BGJ398 for patients with tumors with FGFR genetic alterations
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Phase I Oncology Research Team
Phone: 919.684.6342
Purpose: The purpose of this signal seeking study is to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study.
Reference Number: 00058827
View this trial at ClinicalTrials.gov

A Phase I/IIa Study of BMS 986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects with Select Advanced Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Stephanie Gaillard
Contact: Phase I Oncology Clinical Research Team
Phone: 919.684.6342
Purpose: The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.
Reference Number: 00061125
View this trial at ClinicalTrials.gov

A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Niharika Mettu
Contact: Phase I Oncology Clinical Research Team
Phone: 919.684.6342
Purpose: The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of INCB054828 in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).
Reference Number: 00061567
View this trial at ClinicalTrials.gov

A Multi-Center Study of the Brutons Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with MEDI4736, in Subjects with Relapsed or Refractory Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Niharika Mettu
Contact: Phase I Oncology Clinical Research Team
Phone: 919.684.6342
Purpose: This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in subjects with relapsed or refractory solid tumors.
Reference Number: 00061881
View this trial at ClinicalTrials.gov

A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: This study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation phase (I) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II) which will characterize treatment of LAG525 as a single agent and in combination with PDR001 at the MTD or RP2D.
Reference Number: 00062919
View this trial at ClinicalTrials.gov

A FIRST-IN-HUMAN STUDY OF REPEAT DOSING WITH REGN2810, A MONOCLONAL, FULLY HUMAN ANTIBODY TO PROGRAMMED DEATH 1 (PD-1), AS SINGLE THERAPY AND IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES, IN PATIENTS WITH ADVANCED MALIGNANCIES
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: This is a phase 1, open-label, multicenter, ascending-dose escalation study of REGN2810, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.
Reference Number: 00063093
View this trial at ClinicalTrials.gov

A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects with Solid or Hematological Malignancies
Phase: N/A
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Jeffrey Clarke
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: This screening study is intended for men and women at least 18 years of age who have advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen (HLA) subtype and tumor antigen expression profile. Based on the results, it will be determined if a subject is eligible to be considered for Adaptimmune sponsored clinical trials testing the safety and efficacy of genetically changed T cells targeting specific tumor antigens. No treatment intervention will occur as part of this screening study. Upon enrollment, subjects will be required to provide a blood sample for HLA subtype analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion criteria and do not express the HLA subtypes that are exclusionary for the available interventional clinical trial(s), then the subject will be required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at a central laboratory for the expression (protein or gene) of multiple antigens which may include, but are not limited to NY-ESO-1 and/or LAGE-1a and MAGE A10. Based upon the results of these diagnostic analyses, if eligible, subjects will be referred to an appropriate available interventional clinical trial(s) at the discretion of the Investigator. Following screening, tumor samples will be retained by Adaptimmune for the purpose of developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling which is required for regulatory approval of a new therapeutic product indication.
Reference Number: 00068071
View this trial at ClinicalTrials.gov

A Platform Study Exploring the Safety, Tolerability, Effects on the Tumor Microenvironment, and Efficacy of Pembrolizumab (MK-3475) + INCB Combinations in Advanced Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: This is an open-label, Phase 1b, 3 Part (Part 1a, Part 1b and Part 2), multi-center study. Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination. Once the recommended dose has been identified in Part 1a, subjects with select solid tumor types will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC).
Reference Number: 00068096
View this trial at ClinicalTrials.gov

An Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the safety, pharmacokinetcs, and therapeutic activity of RO6958688 In Combination with Atezolizumab in Patients with Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: This is an open-label, multi-center, dose escalation and expansion Phase IB clinical study of RO6958688 in combination with atezolizumab.
Reference Number: 00068531
View this trial at ClinicalTrials.gov

My Pathway: An Open-Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Jeffrey Clarke
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: This is a multicenter, non-randomized, open-label study designed to evaluate four treatment regimens in patients with advanced cancer for whom there is no available, beneficial treatment. Patients with HER2 overexpression, amplification, or -activating mutation will be treated with Herceptin/Perjeta; those with epidermal growth factor receptor (EGFR), with Tarceva; those with BRAF-activating mutation, with Zelboraf/Cotellic; and those with Hedehog pathway potentially clinically relevant mutation, with Erivedge. Treatment will continue until disease progression or unacceptable toxicity occurs. Study is expected to last up to 5 years.
Reference Number: 00070333
View this trial at ClinicalTrials.gov

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects with Advanced Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: John Strickler
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.
Reference Number: 00070425
View this trial at ClinicalTrials.gov

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat in Combination With Durvalumab in Subjects With Selected Advanced Solid Tumors
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Niharika Mettu
Contact: Phase 1 Oncology Clinical Trials Office
Phone: 919.684.6342
Purpose: The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.
Reference Number: 00073140
View this trial at ClinicalTrials.gov