Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors

Summary

The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy.

The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part.

Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only.

Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.

Conditions

• Pancreatic Cancer
• Non-small Cell Lung Cancer
• Esophagogastric Cancer
• Colorectal Cancer
• Breast Cancer

Interventions

DRUG

Andecaliximab

Administered intravenous infusion

DRUG

Gemcitabine

Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle

DRUG

Nab-paclitaxel

Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle

DRUG

Carboplatin

Administered intravenously on Day 1 of each 21-day treatment cycle

DRUG

Pemetrexed

Administered intravenously on Day 1 of each 21-day treatment cycle

DRUG

Leucovorin

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

DRUG

Oxaliplatin

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

DRUG

5-FU

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

DRUG

Bevacizumab

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

DRUG

Irinotecan

Administered intravenously on Days 1 and 15 of each 28-day treatment cycle

DRUG

Paclitaxel

Administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC)

Sponsors & Collaborators

• Gilead Sciences

  lead INDUSTRY

Principal Investigators

• Gilead Study Director · Gilead Sciences

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-29

Primary Completion

2019-04-23

Completion

2019-04-23

FDA Drug

Yes

Countries

• United States

Study Locations