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Checkpoint Inhibitor

TJ004309 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Tracon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2-8 months
Awards & highlights

Study Summary

This study is evaluating whether a drug called TJ004309 can be used to treat cancer.

Eligible Conditions
  • Solid Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2-8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2-8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerate Dose of TJ004309 plus Atezolizumab
Secondary outcome measures
Assessment of antitumor activity
Determine Phase 2 dose to TJ004309 as a single agent
Determine the Rate of Atezolizumab Immunogenicity
+3 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: TJ004309 plus AtezolizumabExperimental Treatment2 Interventions
TJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TJ004309
2021
Completed Phase 2
~30
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Tracon Pharmaceuticals Inc.Lead Sponsor
21 Previous Clinical Trials
1,018 Total Patients Enrolled
Charles Theuer, MD, PhDStudy DirectorMedical Monitor
4 Previous Clinical Trials
271 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer
2019. "Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03835949.
~6 spots leftby Apr 2025
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