Phase I

AV-203

Description:

AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3 and inhibits its activity. This receptor is expressed in many human cancers and is associated with cancer growth and survival and in development of resistance to anti-cancer agents. In this Phase I study AV-203 is administered intravenously once every 2 weeks in patients with metastatic or advanced solid tumors.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

BAX69

Description:

BAX69 is an anti-macrophage migration inhibitory factor (anti-MIF) antibody. MIF is a pro-inflammatory cytokine that is up-regulated in many human cancers and contributes to growth, angiogenesis and migration of cancer cells. BAX69 is administered intravenously every 2 weeks in a 28 day cycle in patients with malignant solid tumors.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

BNC105P

Description: BNC105P is a vascular disrupting agent that inhibits tubulin polymerization, causing cell cycle arrest and disruption of the tumor vasculature. It is administered intravenously on days 1 and 8 of a 21 day cycle in combination with Everolimus in patients with metastatic clear cell renal carcinoma after progressing on prior tyrosine kinase inhibitors.
Type(s) of Cancer: Kidney
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

BT062

Description:

BT062 is an immunoconjugate consisting of anti CD138 antibody and cytotoxic agent maytansinoid DM4. CD138 is over-expressed on multiple myeloma cells compared to normal plasma cells. BT062 will be administered on days 1, 8 and 15 with Lenalidomide once daily on days 1-21 in patients with relapsed or refractory multiple myeloma.


Type(s) of Cancer: Multiple Myeloma
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

Cabazitaxel

Description:

Cabazitaxel is a new taxoid, which promotes tubulin assembly and has shown strong antitumor activity against a broad spectrum of tumor models including those sensitive as well as resistant or refractory to other taxanes such as docetaxel. This is a Phase I safety and pharmacokinetic study of XRP6258 (Cabazitaxel) in advanced solid tumor patients with varying degrees of hepatic impairment.


Study Phase(s): Phase I
Category: Organ Dysfunction
Contact: Epp Goodwin at (210) 450-5798

CFG920

Description:

CFG920 is a non-steroidal, reversible dual inhibitor of CYP17 and CYP11B2 with potential antiandrogen and antineoplastic activities. In this Phase I/II study CFG920 will be administered orally in patients with metastatic castration-resistant prostate cancer after progressing (or have refused) on Abiraterone and Docetaxel.


Type(s) of Cancer: Prostate Cancer
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

Crizotinib

Description:

Crizotinib is orally bioavailable ALK and c-MET/HGFR receptor tyrosine kinases inhibitor. This Phase I study evaluates the effect of hepatic impairment on the pharmacokinetics and safety of Crizotinib in advanced cancer patients with solid tumors.


Type(s) of Cancer: Organ Dysfunction
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

CZ48

Description: CZ48 is an analog of the topoisomerase I inhibitor Camptothecin (CPT). CPT is an alkaloid extracted from the Chinese tree. CZ48 is administered orally every day in patients with advanced solid tumors or lymphomas.
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

Dasatinib

Description:

Dasatinib is an oral tyrosine kinase inhibitor of SRC family, BCR-ABL, c-kit, EPHA2 and PDGFß receptors. It is administered in advanced cancer patients with varying levels of liver dysfunction.


Type(s) of Cancer: Organ Dysfunction
Study Phase(s): Phase I
Category: Organ Dysfunction
Contact: Epp Goodwin at (210) 450-5798

Halaven

Description:

Halaven is a synthetic analogue of the marine spong natural product halichondrinB. As an inhibitor of microtubules it blocks the cell division and leads to apoptosis of the cancer cells. In this study Halaven is administered on days 1 and 8 of a 21 day cycle in patients with solid tumors who also have impaired renal function.


Type(s) of Cancer: Organ Dysfunction
Study Phase(s): Phase I
Category: Organ Dysfunction
Contact: Epp Goodwin at (210) 450-5798

IMGN853

Description:

IMGN853 is an immunoconjugate consisting of the humanized monoclonal antibody against folate receptor 1 (FOLR1) conjugated to the cytotoxic maytansinoid DM4. It is administered once every 21 days intravenously in patients with advanced solid tumors with FOLR1 expression. Tumor types which have a high incidence of FOLR1 positivity (serous or endometroid epithelial ovarian cancer, serous endometrial cancer, NSCLC of adenocarcinoma and bronchoalveolar cancer and clear cell renal carcinoma) can enroll without the specific testing.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

Iniparib

Description:

Iniparib inhibits PARP enzyme activity however it also appears to cause DNA damage, induce cell cycle arrest, and also potentiates the cell cycle effects of other anticancer drugs. The current Phase 1/1b dose escalation study of Iniparib (BSI-201/SAR240550) is designed to evaluate the this drug as a single agent and in combination with chemotherapeutic regimens in patients with solid tumors


Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

LDE225

Description:

LDE225 is an oral selective Smo antagonist that downregulates the Hedgehog signal transduction pathway. In this Phase I study the patients with advanced solid tumors receive LDE225 with Warfarin or Bupropion to evaluate the drug-drug interaction.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

M402

Description:

M402 is a heparin sulfate mimetic designed to have antitumor effect without the anticoagulant activity. In this Phase I/II study M402 is administered as daily subcutaneous injection with Gemcitabine in patients with metastatic pancreatic cancer who have not received prior chemotherapy.


Type(s) of Cancer: Pancreas
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

MLN8237

Description:

MLN8237 is an oral selective small molecule inhibitor for Aurora A kinase. Aurora A kinase has a regulatory roll in cell mitosis and is over-expressed in many tumors. In the Phase I part of the study MLN8237 is taken twice a day for 7 days every 21 days with Rituximab and in the Phase II part of the study with Rituximab and Vincristine by patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are CD 20 positive.


Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

MSC1936369

Description:

MSC1936369B is a MEK1/2 inhibitor and SAR245409 is a dual inhibitor of PI3K and mTOR. Both these oral drugs are administered daily in patients with advanced or metastatic KRAS and NRAS mutated non-small cell lung cancer, KRAS and PIK3CA mutated colon cancer, triple negative breast cancer and BRAF mutated melanoma patients.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

RO5045337

Description:

RO5045337 is MDM2 antagonist. It prevents MDM2 protein binding to the tumor suppressor protein p53, restoring so the activity of p53 and the p53 mediated tumor cell death. RO5045337 is administered orally with subcutaneous Cytarabine in patients with acute myelogenous leukemia (AML).


Type(s) of Cancer: Leukemia/Blood/Hematologic
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

RO5429083

Description:

RO5429083 is a humanized monoclonal antibody that binds to CD44, a transmembrane glycoprotein that is expressed in many cells, but what seems to have a more critical role in malignant growth. It is given as an IV infusion once every 2 weeks in patients with metastatic and/or advanced solid tumors that express CD44.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

RTOG 0913

Description:

Description: This is a Phase I/II study of RAD001 (everolimus) for patients with glioblastoma or gliosarcoma (brain tumor). Patients are randomized to receive RAD 001 with the standard treatment of radiation plus temozolomide (oral chemotherapy) or to receive the standard treatment of radiation plus temozolomide alone.


Type(s) of Cancer: Brain
Study Phase(s): Phase I
Contact: Carol Jenkins at (210) 450-5924

TK1258

Description:

TKI258 is a potent receptor tyrosine kinase inhibitor (TKI) that selectively targets VEGFR, FGFR, PDGFR, CST1R, c-KIT, RET, TrkA and FLT3. It is expected to inhibit cellular proliferation and inducing cancer cell apoptosis. TKI258 is administered orally in patients with impaired liver function.


Type(s) of Cancer: Organ Dysfunction
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

VB-111

Description: VB-111 is a gene therapy against tumor blood vessels. It consists of a modified cold virus (Adenovirus) which delivers an endothelial angiogenic-specific promoter and a pro-apoptotic Fas Chimera transgene. It targets the growing blood vessels within the tumor to cause their destruction. VB-111 is administered as a single intravenous infusion in patients with glioblastoma multiforme who have disease progression or recurrence following standard of care treatment with Temozolomide and radiation.
Type(s) of Cancer: Brain
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798