Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

NCT03835949 | Unknown Phase 1 FDA Drug

• 1 other identifier: 4309ST101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.

Conditions

Solid Tumor; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerate Dose of TJ004309 plus Atezolizumab

  Evaluate safety and tolerability and determine a recommended Phase 2 dose of TJ004309 when combined with standard dose atezolizumab in patients with advanced or metastatic cancer. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and coded using MedDRA 14.1.

  Approximately 2-8 months

Secondary Outcomes (6)

• Determine Phase 2 dose to TJ004309 as a single agent

  Approximately 2-8 months

• Trough TJ004309 concentrations

  Approximately 2-8 months

• Trough atezolizumab concentrations

  Approximately 2-8 months

• Determine the Rate of TJ004309 Immunogenicity

  Approximately 2-8 months

• Determine the Rate of Atezolizumab Immunogenicity

  Approximately 2-8 months

Study Arms (1)

TJ004309 plus Atezolizumab

EXPERIMENTAL

TJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab.

Drug: TJ004309; Drug: Atezolizumab

Interventions

TJ004309 DRUG

Antibody to CD73

TJ004309 plus Atezolizumab

Atezolizumab DRUG

Humanized monoclonal antibody to PD-L1

TJ004309 plus Atezolizumab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.
• Measurable disease by iRECIST
• Formalin fixed, paraffin-embedded (FFPE) tumor tissue that permits the preparation of 12 unstained slides of tumor sample- Biopsy must be excisional, incisional, or core. Needle aspiration is insufficient.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 or baseline (except alopecia or neuropathy)
• Adequate organ function
• Willingness and ability to consent for self to participate in study
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if:

• Autoimmune disease requiring treatment within the past twelve months
• Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment
• History of or active interstitial lung disease
• Prior T-cell or NK cell therapy
• Current treatment on another therapeutic clinical trial
• Receipt of systemic anticancer therapy, including investigational agents, within 28 days prior to study treatment
• Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment, and must have fully recovered from any such procedure; and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned within the next 6 months
• Chest radiotherapy ≤ 28 days, wide field radiotherapy ≤ 28 days (defined as \> 50% of volume of pelvic bones or equivalent), or limited field radiation for palliation ≤ 14 days prior to study treatment - such patients must have recovered adequately from any side effects of such therapy.
• Hypertension defined as blood pressure (BP) systolic \> 150 or diastolic \> 90 mm Hg
• Ascites or pericardial effusion that required intervention within 3 months prior to study treatment.
• Brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease, unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for CNS disease over the 7 days prior to study treatment
• Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
• Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
• Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible.
• Any active infection requiring systemic treatment

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (4)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77230, United States

Location

Related Links

• TRACON Pharmaceuticals

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Theuer, MD, PhD

  Medical Monitor

  STUDY DIRECTOR

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: February 5, 2019
• First Posted: February 11, 2019
• Study Start: July 16, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)