Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors for Which Bevacizumab is Indicated

NCT01332721 | Completed Phase 1 Results

• 1 other identifier: 105ST102
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.

Conditions

Adult Solid Tumor

Keywords

TRC105; CD105; Endoglin; Solid Tumors; Avastin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab

  Three patients will be initially enrolled and treated at each dose level. If none of these 3 patients experiences a dose-limiting toxicity (DLT) during the 28-day evaluation period, dose escalation will proceed following review of safety data with appropriate site staff including the principal investigators at all sites. If 1 of 3 patients experiences DLT, the cohort will be expanded to 6 patients. The maximum tolerated dose (MTD) will have been exceeded if ≥ 33% of patients experience DLT in a given cohort. DLT will have occurred when a patient has 1 or more toxicity listed in the table below that is at least possibly related to the combination of bevacizumab and TRC105 during the first 28 days (cycle 1).

  1.5 years

Secondary Outcomes (3)

• TRC105 Pharmacokinetic Concentrations

  1.5 years

• Immune Response to TRC105

  1.5 years

• Objective Response According to RECIST 1.1

  1.5 years

Study Arms (1)

TRC105 and Bevacizumab

EXPERIMENTAL

Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Drug: TRC105 and Bevacizumab

Interventions

TRC105 and Bevacizumab DRUG

Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Also known as: Chimeric Antibody (TRC105) to CD105, Avastin

TRC105 and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven advanced or metastatic solid cancer
• Measurable disease, evaluable disease or elevation of a relevant soluble tumor marker (e.g., CEA, PSA, CA125)
• Age of 18 years or older
• ECOG performance status of 0 or 1
• Resolution of all acute AEs resulting from prior cancer therapies to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)
• Adequate organ function
• Willing and able to consent for self to participate in study

You may not qualify if:

• Prior treatment with TRC105
• Serious dose-limiting toxicity related to prior bevacizumab
• Current treatment on another therapeutic clinical trial
• Receipt of an investigational agent within 28 days of starting study treatment
• Prior surgery (including open biopsy) within 28 days of starting the study treatment
• Prior radiation therapy or systemic therapy within 21 days of starting the study treatment
• Minor surgical procedures such as fine needle aspirations, Mediport placement or core biopsies within 7 days of study treatment
• Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg)
• Symptomatic pericardial or pleural effusions
• Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks
• History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease (except in the expansion cohort at the MTD where brain metastases or primary brain tumors are eligible)
• Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months
• Active bleeding or pathologic condition that carries a high risk of bleeding
• Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
• Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last 28 days

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

UCLA Hematology and Oncology

Santa Monica, California, 90404, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

carotuximab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr Charles Theuer
• Organization: TRACON Pharmaceuticals

ctheuer@traconpharma.com

8585500780

Study Officials

• Charles P Theuer, MD

  Tracon Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 5, 2018
• Results First Posted: March 28, 2014

Record last verified: 2018-11

Locations

US (4)