TJ004309 for Gastrointestinal Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Arizona Oncology Associates, Tucson, AZ
Gastrointestinal Cancers+9 More
TJ004309 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors

See full description

Eligible Conditions

  • Gastrointestinal Cancers
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Ovarian Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Ovarian Carcinoma
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gastrointestinal Cancers

Study Objectives

This trial is evaluating whether TJ004309 will improve 1 primary outcome and 13 secondary outcomes in patients with Gastrointestinal Cancers. Measurement will happen over the course of Up to 120 weeks.

Day 21
Assessment of PK parameter: Cmax
Assessment of PK parameter: tmax
Pharmacokinetic (PK) parameters: Area under the curve (AUC0-T)
Up to 120 weeks
Disease control rate (DCR)
Duration of response (DOR)
Incidence of treatment emergent adverse events
Number of participants with abnormal physical examination results
Number of participants with laboratory value abnormalities
Number of participants with vital sign abnormalities
Objective Response Rate (ORR)
Objective Response Rate (ORR) in each Tumor Type
Overall survival (OS)
Pharmacokinetic profiles of serum TJ004309 and atezolizumab
Progression-free-survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Gastrointestinal Cancers

Trial Design

1 Treatment Group

TJ004309 and Atezolizumab
1 of 1
Experimental Treatment

This trial requires 60 total participants across 1 different treatment group

This trial involves a single treatment. TJ004309 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

TJ004309 and Atezolizumab
Drug
TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from pre-dose in day 1 of cycle 1 to post-dose in day 21 of cycle 1 (each cycle is 21 days)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from pre-dose in day 1 of cycle 1 to post-dose in day 21 of cycle 1 (each cycle is 21 days) for reporting.

Closest Location

Arizona Oncology Associates - Tucson, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Gastrointestinal Cancers or one of the other 9 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer subjects with any high-grade serous component, progressed on or after platinum-containing therapy and not eligible for further platinum containing treatment (platinum-resistant, platinum-refractory disease defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of receiving the last dose of platinum-based treatment).
Histologically or cytologically confirmed metastatic NSCLC
Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx)
Histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma
Histologically or cytologically confirmed unresectable, locally advanced or metastatic TNBC (confirmed HER2-negative, estrogen receptor-negative and progesterone receptor-negative)
Histologically confirmed ovarian cancer of all high-grade epithelial types who are IO treatment naïve and have progressed after 3 months on or after platinum-containing therapy
PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and Combined Proportion Score (CPS) ≥ 1% for all other tumor types
A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy
Patients should have no more than 5 prior lines of therapies
Cohort 2 - (Optional for the ovarian cohort) Pre-treatment fresh tumor biopsies and paired treatment fresh tumor biopsies will be collected from at least 5 patients. Biopsy must be excisional, incisional, or core.

Patient Q&A Section

Can gastrointestinal cancers be cured?

"There were substantial improvements in survivorship of gastrointestinal cancer patients since the introduction of chemotherapy in the 1960s. These improvements have resulted in more cancer patients being cured of gastrointestinal cancers such as colorectal cancer. The proportion of people who have been cured of cancer by the end of life, however, is still very low and highlights the need for improvement in cancer survivorship interventions and the development of new cancer medications." - Anonymous Online Contributor

Unverified Answer

What are the signs of gastrointestinal cancers?

"The five most common gastrointestinal cancers can present with pain, a change in appearance or weight, itching, gastrointestinal bleeding or a change in bowel habits (either constipation or diarrhoea). Pain in colorectal cancer may be accompanied by perineal swelling. Bleeding from gastrointestinal cancers may occur anywhere within the gastrointestinal tract, including the oesophagus, stomach, duodenum, colon, rectum, liver, bile ducts etc. The presence of haemorrhoids and melena in association with abdominal pain in the setting of gastrointestinal cancer must prompt further investigation as to the presence of oesophageal or gastric cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for gastrointestinal cancers?

"Common treatment strategies include surgery (laparotomy or laparoscopy), chemotherapy, radiation, targeted therapy, or a combination of these therapies. The role for biopsy remains unclear. It may be indicated for certain histology types." - Anonymous Online Contributor

Unverified Answer

How many people get gastrointestinal cancers a year in the United States?

"Approximately 41,000 people develop [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) each year in the United States. Of these, over 30,000 develop adenocarcinoma. At 10 years from diagnosis, the cancer-specific survival is 80%. By age 65, however, this declines to 62%." - Anonymous Online Contributor

Unverified Answer

What causes gastrointestinal cancers?

"Gastrointestinal cancers occur as a result of multiple etiologies. Risk factors such as smoking, alcohol use, obesity, and infectious diseases all contribute to gastrointestinal cancer etiology." - Anonymous Online Contributor

Unverified Answer

What is gastrointestinal cancers?

"GICs are the leading cause of deaths due to cancer in the developed world. They have become the leading cause of cancer deaths in low-middle income countries. A more aggressive approach to prevention and cure is essential." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of gastrointestinal cancers?

"Risk factors for colorectal cancer and gastric cancer were similar. The primary cause of gastric cancers is not clear. However, it is hypothesized that chronic inflammation from NSAIDs or alcohol may contribute to gastric cancers. This suggests that gastric cancers are more likely to occur later in adulthood. The primary cause of colorectal cancers is not clear. However, the primary cause of rectal and colon cancers is most likely to be dietary factors. Higher fiber intake, particularly dietary fiber from vegetables, and high fiber dietary supplements, may help reduce the risks of colorectal cancer." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets gastrointestinal cancers?

"There is a substantial age range at which GI cancers are diagnosed, highlighting the need for tailored care for younger and older patients. Better understanding cancer surveillance and risk factors needs to be developed, especially for older patients considering surgical intervention." - Anonymous Online Contributor

Unverified Answer

What does tj004309 usually treat?

"After 6 months of treatment (maximum 6 months), the commonest side effects were abdominal pain (3.1%), constipation (2.5%), diarrhea (2.0%), fatigue (2.0%), vomiting (1.3%), nausea (1.0%), loss of appetite (1.0%), increased cholesterol (1.0%). There were three cases of liver function test abnormalities. Three patients suffered severe nausea, vomited and/or had diarrhea when the dose was increased. There were no patients who exhibited a decrease of treatment dose." - Anonymous Online Contributor

Unverified Answer

Has tj004309 proven to be more effective than a placebo?

"The data indicate that Tj004309 is an effective chemopreventive agent after it has already been established that it can inhibit the development of new pancreatic intraepithelial neoplasia." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for gastrointestinal cancers?

"Overall, survival from the time of diagnosis of gastrointestinal cancers improved in the time period of 1987-1996, to the years thereafter. There was significant variation among sites of primary, but not secondary, cancer with some sites of gastrointestinal cancers having improved survival while others had worse survival. Survival was worse in men from all sites of cancer, especially those diagnosed with gastric cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating gastrointestinal cancers?

"The prognosis of the gastrointestinal cancers was poor. Although conventional chemotherapy had a benefit against several types of gastrointestinal cancers, the majority of the patients died because of recurrent or metastatic gastrointestinal cancers despite treatment with drugs such as methotrexate, 5-fluorouracil, capecitabine, cyclophosphamide, streptozotocin, irinotecan, oxaliplatin, 5-fluorouracil-cobalamin-E2, fluorouracil, and leucovorin." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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