CLINICAL TRIAL

CAB-ROR2-ADC for Sarcoma

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a drug may help treat solid tumors.

See full description

About the trial for Sarcoma

Eligible Conditions
Non-Small Cell Lung Carcinoma (NSCLC) · Triple Negative Breast Neoplasms · Head and Neck Cancer · Sarcoma · Breast Cancer (Triple Negative Breast Cancer (TNBC)) · Melanoma · Head and Neck Neoplasms

Treatment Groups

This trial involves 2 different treatments. CAB-ROR2-ADC 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 & 2 and have already been tested with other people.

Experimental Group 1
CAB-ROR2-ADC
BIOLOGICAL
Experimental Group 2
CAB-ROR2-ADC
BIOLOGICAL
+
PD-1 inhibitor
BIOLOGICAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
who have not received prior systemic therapy will be eligible For the dose expansion phase, patients will be eligible if they have locally advanced unresectable or metastatic, non-small cell lung cancer, triple negative breast cancer, or soft tissue sarcoma who have not received prior systemic therapy. show original
Patients must have a disease that can be measured. show original
Any person aged 18 years or older. show original
Adequate renal function
Adequate liver function
Adequate hematological function
Have a low Eastern Cooperative Oncology Group (ECOG) performance status. show original
The patient has a life expectancy of at least three months. show original
Patients with advanced solid tumors that are not operable or have metastasized and for whom no cure is available can participate in this study 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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 24 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 CAB-ROR2-ADC will improve 7 primary outcomes and 13 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of MTD will be assessed from first treatment cycle (3 weeks).

Maximum Tolerated Dose (MTD)
MTD WILL BE ASSESSED FROM FIRST TREATMENT CYCLE (3 WEEKS)
Number of DLTs
MTD WILL BE ASSESSED FROM FIRST TREATMENT CYCLE (3 WEEKS)
Dose Limiting Toxicities (DLTs)
DLT WILL BE ASSESSED FROM FIRST TREATMENT CYCLE (3 WEEKS)
Number of DLTs
DLT WILL BE ASSESSED FROM FIRST TREATMENT CYCLE (3 WEEKS)
Phase 1 and 2: Progression-free survival (PFS)
UP TO 24 MONTHS
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first
UP TO 24 MONTHS
Phase 1 and 2: Time to response (TTR)
UP TO 24 MONTHS
Time from the first dose of investigational product until the first documentation of OR
UP TO 24 MONTHS
Phase 1 and 2: Overall survival (OS)
UP TO 24 MONTHS
Time from the first dose of BA3021 treatment until death due to any cause
UP TO 24 MONTHS
Phase 1 and 2: Tumor size
UP TO 24 MONTHS
Percent change from baseline in tumor size
UP TO 24 MONTHS
See More

Patient Q & A Section

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

How many people get sarcoma a year in the United States?

The incidence and mortality of soft-tissue sarcomas, including osteosarcomas, in the United States are lower than the rates of other sarcomas, which could be partially due to the early detection of osteosarcomas as they appear on radiographs, which allows for the early correction of bone alignment when necessary. In the future, improvements in treatment, especially new combinations with chemotherapy, may enhance the survival of patients with sarcomas.

Anonymous Patient Answer

What are the signs of sarcoma?

Signs of sarcoma may include red spots or skin lesions, loss of appetite, weight loss, loss of sensation such as numbness or tingling, swelling of the eyes, eyelid or on the face, shortness of breath, and back pain. Sarcoma may also result in loss of muscle tone, and in many cases it results in an enlarged limb.\n

Anonymous Patient Answer

What causes sarcoma?

Sarcoma develops from malignant cells originating from the mesenchyme. Sarcomas are not caused by environmental factors, but are often associated with a family history of cancers.

Anonymous Patient Answer

Can sarcoma be cured?

Most sarcoma patients have some localized recurrence of their disease at the time of diagnosis. Patients can be curable with a 50-75% survival rate if they are diagnosed early on and complete therapy can be undertaken at a centralized institution. However, many patients may need periodic therapy as their disease progresses.

Anonymous Patient Answer

What is sarcoma?

As there are no single diagnostic criteria for HN, multiple diagnostic approaches, such as a physical examination, laboratory studies, imaging studies, and fine needle aspiration biopsy, can confirm the diagnosis of HN.

Anonymous Patient Answer

What does cab-ror2-adc usually treat?

This is a well documented drug that has proved effective in treating most cancers including sarcomas and lymphomas. In terms of efficacy and safety, this drug is one of the safest. However, the toxicity profile is severe and can be very serious. Most famously is the adverse effect of high CNS-associated CNS tumor necrosis in children caused by cabo-ror2-adc use. This is well known to occur in several cancers, but it is unique to a number of treatments including cabo-ror2-adc and warrants reporting to the FDA.

Anonymous Patient Answer

Have there been any new discoveries for treating sarcoma?

There have been a couple of new discoveries lately in the medical and scientific communities, but it has been a very slow process when you consider how many people with cancer in the world have absolutely no treatment options available. It is not surprising that with sarcoma being a deadly cancer it would take a little longer to be able to fully discover its own treatments. In addition to looking at medications already on the market we need to look at other therapies because the sarcoma community doesn't get enough attention from the medical community at large. Many of the advancements that have come through the last couple of years for those who have the sarcoma type of cancer are the direct result of being able to look at many different different drugs.

Anonymous Patient Answer

What is cab-ror2-adc?

The following clinical features were the most prevalent: female preference to female physicians, good perception of health care, negative attitudes toward cancer, and positive perception of the general population as well as physicians. The findings suggest that the current public health awareness campaigns emphasizing the role of physician gender may not have captured the complete picture of how women perceive their own health care. Thus, we suggest that more efforts need to be made regarding perceptions in health care settings.

Anonymous Patient Answer

What is the survival rate for sarcoma?

The overall survival rate for [osteosarcoma](https://www.withpower.com/clinical-trials/osteosarcoma)s and Ewing's sarcomas is 50% and 38%. For ES, the five-year survival rate improves as the children with ES under-40 years of age have a five-year survival rate of 41.6% and those over the age of 40 have a five-year survival rate of 27.2%. For OS, the five-year survival rate is 37% and improves as each child, with OS under 40 years of age (n = 1,700), has a five-year survival rate of 34.2% and those over age 40 (n = 6,800) has a five-year survival rate of 16.6%.

Anonymous Patient Answer

What is the latest research for sarcoma?

To date, there’s not much research looking into sarcoma therapy, and studies are just starting to be conducted. It’s estimated that the global incidence of sarcoma is less than 1,000,000 cases a year and that it only affects about 400. However, there’s still no definitive way to treat sarcoma in its primary form. But we might be on the right track. It seems that in order to make new treatments to better help sarcoma patients, we have to learn more about the biology of this disease. In addition, scientists have been researching better ways to make immune system more effective in its fight against cancer cells.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Sarcoma by sharing your contact details with the study coordinator.