August 15, 2016

All Trials

ANEMIA

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BILLIARY CANCER

A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy Regimen

BREAST CANCER

A Phase III, Multicenter, Randomized,Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulestrant Versus Alpelisib Plus Fulvestrant in Patients with Hormone Receptor-Postitive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer who Progressed During or after CDK4/6 Inhibitor and Endocrine Combination Therapy

An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer (ELECTRA)

A Phase III, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant plus Everolimus Compared with Exemestane plus Everolimus in Patients with Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

CERVICAL CANCER

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CINV (CHEMOTHERAPY INDUCED NAUSEA AND VOMITING)

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COLON CANCER

A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination with mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma

ESOPHAGEAL CANCER

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GASTRIC CANCER

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)

HEAD AND NECK CANCER

A Phase 1b/2 Study of the Combination of Pepinemab and Pembrolizumab in Patients with Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti-Claudin-1 Antibody) as a Single Agent and in Combination with Pembrolizumab (antiPD-1 antibody) in Adult Patients with Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma

A Trial to Investigate TransCon TLR7/8 Agonist in Combination with Pembrolizumab, TransCon TLR7/8 Agonist in Combination with TransCon IL-2 β/γ, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

HEMATOLOGICAL(BLOOD) MALIGNANCIES

A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects with Hematologic Malignancies

A Phase Ia/Ib, First-in-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG2501 in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma

An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)

ITP (IDIOPATHIC THROMBOCYTOPENIC PURPURA)

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LEUKEMIA

A phase IB/II study of APG-2575 as a single agent or in combination with other therapeutics agents in patients with relapsed and/or refactory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (SACRED)

A phase 1B study of the pharmacokinetics, safety and efficacy of orally administered HQP1351 in subjects with refactory Chronic Myeloid Leukemia (CML)

A Multi-Center, Parallel, Double-Blinded, Placebo Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® plus Standard Medical Treatment Compared to Placebo plus Standard Medical Treatment to Prevent Infections in Patients with Hypogammaglobulinemia and Recurrent or Severe Infections Associated with B-cell Chronic Lymphocytic Leukemia

LIVER CANCER

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LUNG

Randomized, Controlled, Open-label, Phase 3, Global Multi-Center Trial to Assess the Efficacy and Safety of Zipalertinib plus Chemotherapy versus Chemotherapy alone, in Patients with Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations

A RANDOMIZED, DOUBLE-BLIND PHASE 2/3 STUDY OF FIANLIMAB (ANTI-LAG-3 ANTIBODY) IN COMBINATION WITH CEMIPLIMAB (ANTI-PD-1 ANTIBODY) VERSUS CEMIPLIMAB MONOTHERAPY IN FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NONSMALL CELL LUNG CANCER (NSCLC) WITH TUMORS EXPRESSING PD-L1 ≥50%

A RANDOMIZED, DOUBLE-BLIND PHASE 2/3 STUDY OF FIANLIMAB (ANTI-LAG-3 ANTIBODY), CEMIPLIMAB (ANTI-PD-1 ANTIBODY), AND CHEMOTHERAPY VERSUS CEMIPLIMAB AND CHEMOTHERAPY IN FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) IRRESPECTIVE OF PD-L1 EXPRESSION LEVELS

A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Malignant Tumors and Relapsed/Refractory Small Cell Lung Cancer

EF-36/Keynote B36: A pilot, single arm, open-label study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with pembrolizumab for first line treatment of advanced or metastatic intrathoracic non-small cell lung cancer

A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy

A Randomized, Open-label Study of HLX10 plus Chemotherapy (CarboplatinEtoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC)

A Phase 3, Open-Label, Randomized, Multi-center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined with Domvanalimab (AB154) Compared to Pembrolizumab in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

LYMPHOMA

MDS (MYELODYSPLASTIC SNYDROME)

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MELANOMA

A phase 2a, open-label study of T3011 in combination with Cobimetinib in patients with advanced melanoma

A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined with Nivolumab versus Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors

MULTIPLE MYELOMA

A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of Intravenous Modakafusp Alfa as Part of Combination Therapy in Adult Patients With Multiple Myeloma

MYELOFIBROSIS

A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis 

NEUROENDOCRINE

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OVARIAN

A Phase 1B/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma based on Acrivon Oncosignature® Status

PAIN MANAGEMENT

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PANCREATIC CANCER

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Fluorouracil (5-FU) in Patients with Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine

A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma

A Phase 1b/2 Randomized Study of AVB-S6-500 plus Nab-paclitaxel and Gemcitabine in Patients with Locally Advanced or Metastatic Pancreatic Adenocarcinoma

POLYCYTHEMIA VERA

A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients with Phlebotomy-Requiring Polycythemia Vera

PROSTATE CANCER

A Phase 2/3, Randomized, Open-label, Study of MGC018 Versus Androgen Receptor Axis-targeted Therapy (Abiraterone or Enzalutamide) in Participants with Metastatic Castration-resistant Prostate Cancer

RENAL CELL / KIDNEY CANCER

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SOLID TUMOR

A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI101150 Administered as Monotherapy or in Combination with Pembrolizumab in Patients with Solid Tumors

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants with Advanced Malignancies

A Phase 1, Open-label Study of BS006, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors

A First-in-Human, Multicenter, Phase 1, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors

A Phase 1b Dose Escalation and Expansion Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATRC-101 as Monotherapy and in Combination with Other Anticancer Agents in Adults with Advanced Solid Malignancies

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients with Advanced Cancer

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY AND CLINICAL ACTIVITY OF DECOY20 IN PATIENTS WITH ADVANCED SOLID TUMORS

An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients with Tissue Factor Positive Advanced or Metastatic Solid Tumors   

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of  TransCon IL-2 β/γ Alone or in Combination with Pembrolizumab or Standard of Care Chemotherapy in Participants Aged 18 Years or Older with Locally Advanced or Metastatic Solid Tumor Malignancies

A Phase 1/2a, Multicenter, Open-Label, Non-Randomized First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303 in Patients with Advanced/Metastatic Solid Tumors

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumor

An Open-Label, Multiple-Dose, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects with Solid Tumors or Lymphoma

Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies 

A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Locally Advanced or Metastatic Solid Tumors

Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

A Phase 1, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients with Advanced Solid Tumor or Hematological Malignancy and either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment

Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 with Dose Expansion Phase, in Subjects with Advanced Solid Tumors

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF CUE-102 MONOTHERAPY IN HLA-A*0201 POSITIVE PATIENTS WITH WT1 POSITIVE RECURRENT/METASTATIC CANCERS

A Phase 1 Study to assess the effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients with Advanced Solid Tumors Harboring ROS1 OR NTRK1-3 Rearrangements

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated With An Anti-PD-1 Therapy

A Phase 1, Open-Label, Multicenter, Dose-Escalation, Dose Expansion, and Dose-Randomization Study of IO-108 as Monotherapy and in Combination with Pembrolizumab, in Adult Patients with Advanced Relapsed or Refractory Solid Tumors

A Phase 1, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-1010 (IL12-FHAB) in Adult Patients with Advanced Solid Tumors

A Phase 1/2a, Multicenter, Open-Label, Non-Randomized First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors

A Phase 1, Open-Label, Dose Escalation of HBI-2438 in Patients with Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation

A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors

A Phase I, Open-label, Dose-escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Modified Salmonella Typhimurium SGN1 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors

A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Malignant Tumors and Relapsed/Refractory Small Cell Lung Cancer

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination With Toripalimab, in Participants With Advanced Solid Tumors

A Multicenter, Open-Label, Phase I/II Study of EOS884448 in combination with standard of care and/or investigational therapies in participants with advanced solid tumors

An Open-Label, Multicenter, Multi-Arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults with Advanced Solid Tumors

A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients with Colorectal Cancer and Other Solid Tumors

 UROTHELIAL CANCER  

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WALDENSTROM’S MACROGLOBULINEMIA

An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)