BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

BAY1179470 will be administered as a 1-hour intravenous infusion.

BAY1179470

Bayer Study Director

An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors

First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors

An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY 1179470 in Subjects With Advanced, Refractory Solid Tumors.

Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.

Bayer

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Breast Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Mesothelioma

Mesothelioma, Malignant

Adenocarcinoma of Lung

Malignant Mesothelioma

Lung Adenocarcinoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

Anetumab ravtansine

Immunoconjugates

Immunologic Factors

Cohort 1: Safety, tolerability and PK of 4.5 mg/kg dose given Q3W. Proceeding to Cohort 2 or not will be decided based on both safety variables during Cycle 1 (21 days) of 3 to 6 subjects in Cohort 1 and PK obtained from Cycle 1 (at least Day 1 to Day 5).

Cohort 2: Safety, tolerability and PK of 6.5 mg/kg dose given Q3W. Whether recruitment will be continued up to 9 subjects for Cohort 2 or not will be decided based on safety variables during Cycle 1 (21 days) of the first 3 subjects in Cohort 2. The safety and tolerability of 6.5 mg/kg will be assessed based on the data of 9 subjects during Cycle 1 in Cohort 2, and considering long term toxicity, the safety and tolerability of BAY94-9343 will be assessed all safety data by the end of 3 cycles in Cohort 2.

Cohort 1: 4.5 mg/kg of BAY 94-9343 at Q3W dose regimen. Cohort 2: 6.5 mg/kg of BAY 94-9343 at Q3W dose regimen.

BAY94-9343

The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with advanced, refractory solid tumors.

The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.

Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

An Open Label, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks (Q3W) in Japanese Subjects With Advanced Malignancies

QBI-139 is being administered once a week over a two hour infusion in escalating doses.

QBI-139

The purposes of this trial are:

* To evaluate the toxicity and tolerability of QBI-139 in patients with advanced refractory solid tumors.
* To determine the maximum tolerated dose of QBI-139 in patients with advanced, refractory solid tumors.

Patients will receive QBI-139 by IV infusion over at least one hour once weekly for three weeks. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 to 6 patients receive escalating doses of QBI-139 until the maximum tolerated dose (MTD) is determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors	NCT01881217	Neoplasms	BAY1179470	20 Years -	Bayer
Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies	NCT02485119	Neoplasms	BAY94-9343	20 Years -	Bayer
A Study of QBI-139 in Subjects With Advanced Solid Tumors	NCT00818831	Solid Tumors	QBI-139	18 Years -	Quintessence Biosciences, Inc.

Spots Global Cancer Trial Database for advanced, refractory solid tumors