A Phase 1 Dose-Escalation Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

Tracon Pharmaceuticals Inc.4 sites in 1 country36 target enrollmentJuly 16, 2019

ConditionsSolid Tumor Metastatic Cancer

InterventionsTJ004309 Atezolizumab

DrugsTJ004309 Atezolizumab

Overview

Phase: Phase 1
Intervention: TJ004309
Conditions: Solid Tumor
Sponsor: Tracon Pharmaceuticals Inc.
Enrollment: 36
Locations: 4
Primary Endpoint: Maximum Tolerate Dose of TJ004309 plus Atezolizumab
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2019

End Date

June 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tracon Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.

Arms & Interventions

TJ004309 plus Atezolizumab

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

Intervention: TJ004309

TJ004309 plus Atezolizumab

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

Intervention: Atezolizumab

Outcomes

Primary Outcomes

Maximum Tolerate Dose of TJ004309 plus Atezolizumab

Time Frame: Approximately 2-8 months

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.