CLINICAL TRIAL

XB002 for Carcinoma, Ovarian Epithelial

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Recruiting · 18+ · All Sexes · San Antonio, TX

This study is evaluating whether a new drug can be safely given to people with cancer.

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About the trial for Carcinoma, Ovarian Epithelial

Eligible Conditions
Triple Negative Breast Neoplasms · Metastatic Castration-resistant Prostate Cancer · Breast Neoplasms · Ovarian Cancer · Esophageal SCC · Breast Cancer (Triple Negative Breast Cancer (TNBC)) · Hormone Receptor-positive Breast Cancer · Carcinoma, Ovarian Epithelial · Ovarian Cancer (Epithelial) · Cervical Cancers · Non-Small Cell Lung Carcinoma (NSCLC) · Urothelial Cancer · Malignant Neoplasm of Pancreas · SCCHN

Treatment Groups

This trial involves 2 different treatments. XB002 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
XB002
DRUG
Experimental Group 2
XB002
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Ovarian Epithelial or one of the other 13 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have a solid tumor that is inoperable, locally advanced, metastatic, or recurrent. show original
The subject has received standard life-prolonging therapies. show original
Subjects with Stage IV NSCLC who have documented radiographic disease progression during or following their last systemic anticancer therapy. show original
Subjects with transitional cell histology (including renal pelvis, ureter, urinary bladder, urethra) who have documented radiographic disease progression during or following their last systemic anticancer therapy. show original
Subjects with high-grade serous ovarian cancer, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) who have platinum-resistant disease following treatment with platinum-containing chemotherapy. show original
Subjects with head and neck cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. show original
Cohort G (Pancreatic Cancer): Subjects with pancreatic cancer (adenocarcinoma histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy.
Subjects with esophageal cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. show original
Subjects with metastatic, castration resistant adenocarcinoma of the prostate show original
Subjects with persistent, recurrent, or metastatic carcinoma of the uterine cervix who have documented radiographic disease progression during or following their last systemic anticancer therapy. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 30 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 30 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether XB002 will improve 2 primary outcomes and 10 secondary outcomes in patients with Carcinoma, Ovarian Epithelial. Measurement will happen over the course of 12 months.

Cohort-Expansion Stage: overall survival
12 MONTHS
To evaluate overall survival
12 MONTHS
Cohort-Expansion Stage: Objective Response Rate (ORR)
12 MONTHS
To evaluate preliminary efficacy of XB002 by estimating the ORR per RECIST 1.1 as assessed by the Investigator
12 MONTHS
Dose-Escalation Stage: MTD/recommended dose for XB002
18 MONTHS
To determine the MTD and/or RD for further evaluation of IV administration of XB002 in subjects with advanced malignancies
18 MONTHS
Anti-tumor activity of XB002: Progression Free Survival (PFS)
30 MONTHS
To evaluate the anti-tumor activity of XB002, as measured by PFS, per RECIST 1.1 as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)
30 MONTHS
Anti-tumor activity of XB002: Duration of Response (DOR)
30 MONTHS
To evaluate the anti-tumor activity of XB002, as measured by DOR, per RECIST 1.1 as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)
30 MONTHS
Dose-Escalation Stage: Anti-tumor activity of XB002: Objective Response Rate (ORR)
30 MONTHS
To evaluate the anti-tumor activity of XB002, as measured by ORR, per RECIST 1.1 as assessed by the Investigator
30 MONTHS
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Patient Q & A Section

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

What are the latest developments in xb002 for therapeutic use?

The development of new, more effective targeted therapies has led to an increase in our understanding of cell signaling pathways associated with ovarian carcinogenesis and progression. Further studies will be needed to develop methods of assessing response to these agents and their potential role in the management of ovarian cancer.

Anonymous Patient Answer

Can carcinoma, ovarian epithelial be cured?

Ovarian carcinoma can be cured; however, there may be long-term side effects from adjuvant chemotherapy. Ovarian epithelial carcinomas can be cured with surgery. There may be long-term side effects from adjuvant chemotherapy.

Anonymous Patient Answer

What are the chances of developing carcinoma, ovarian epithelial?

The overall risk of developing carcinoma was 2%, and there was no significant difference between women who had a BRCA mutation and those without a mutation. Women who did not develop [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) were at an increased risk of developing a second primary cancer, particularly ovarian epithelial cancer (EOC), but this risk was not significantly different from the risk found in women without a BRCA mutation.

Anonymous Patient Answer

What is the average age someone gets carcinoma, ovarian epithelial?

There was a significant decreasing trend in the age at diagnosis from 1980 to 2003. This suggests that cancer control programs should focus on younger patients.

Anonymous Patient Answer

What does xb002 usually treat?

There has been little information on the usual characteristics of XB002 responders in women with advanced ovarian cancer. This preliminary analysis suggests that a majority of XB002 responders exhibit no specific histological features suggestive of current chemotherapy response. Further investigation into the heterogeneity of ovarian cancer phenotype is warranted before conclusions regarding treatment response can be made.

Anonymous Patient Answer

What are the common side effects of xb002?

These data suggest that the safety profile of xb002 is comparable to that of previously investigated drugs in this class, including antiangiogenic drugs (bevacizumab, sorafenib, sunitinib, etc.) The fact that no major grade 3 or 4 toxicities were observed In a recent study suggests that xb002 has a favorable safety profile compared to these previous agents, as well.

Anonymous Patient Answer

Does xb002 improve quality of life for those with carcinoma, ovarian epithelial?

The addition of Xb002 to chemotherapy increased time to progression and improved overall survival compared with chemotherapy alone in a cohort of patients with epithelial ovarian cancer.

Anonymous Patient Answer

What is the survival rate for carcinoma, ovarian epithelial?

Ovarian cancer is highly aggressive and tends to recur within 1 year after surgical resection in most cases. It is therefore imperative that patients have regular screening to detect early recurrence. Patients should be encouraged to have their ovaries removed if they develop fertility problems during their disease course.

Anonymous Patient Answer

How many people get carcinoma, ovarian epithelial a year in the United States?

The prevalence of carcinoma, ovarian epithelium is relatively low in the US population, despite the high incidence of this disease. Most cases occur in developed countries.

Anonymous Patient Answer

How serious can carcinoma, ovarian epithelial be?

The 5-year survival rate for serous epithelial ovarian cancer is 75%. In addition to being aggressive, serous ovarian cancer remains highly recurrent. Other factors influencing survival include age, stage at diagnosis, and presence of ascites, all of which have now been incorporated into the standard prognostic staging system. Survival rates vary substantially among races and ethnic groups. For example, African Americans, Hispanics, and Asians have significantly poorer outcomes than Caucasians.

Anonymous Patient Answer

Have there been other clinical trials involving xb002?

Xb002 is currently undergoing a Phase I trial in combination with paclitaxel and carboplatin in ovarian cancer. Xb002 may be effective as an anti-cancer agent.

Anonymous Patient Answer
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