Clinical trial for High Grade Epithelial Ovarian Cancer
Official title Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
ClinicalTrials.gov ID: NCT05579366
What this study is testing
What is Rina-S?
Rina-S is an investigational medicine being studied as a potential treatment for high-grade epithelial ovarian cancer. Rina-S is designed to attach to specific markers on cancer cells and deliver a drug directly to them.
Also referred to as PRO1184, Rinatabart sesutecan, GEN1184.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to check if the drug is safe and to learn how it works in the body.
- Who it's for
- The study is looking for adults with solid tumor cancers that have spread to other parts of the body or cannot be taken out with surgery.
- What's involved
- Participants will receive the drug Rina-S and undergo regular medical tests to monitor their health and any side effects.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer...
- Previously received therapies known to confer clinical benefit.
- Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.
- High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low...
- Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is...
You likely can't join if
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis...
- Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate. Note: Other protocol-defined inclusion/exclusion may apply.
See the full eligibility criteria
- Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial...
- Previously received therapies known to confer clinical benefit.
- Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.
- High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
- Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy.
- Participants must have platinum-resistant ovarian cancer.
- Participants must have received prior bevacizumab or approved biosimilar.
- Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a Clinical Laboratory Improvement Amendments [CLIA]-certified...
- Participants must have platinum-sensitive ovarian cancer.
- Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
- Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy.
- Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC).
- Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors). Cohort D5
- Participants must have histologically or cytologically confirmed EC.
- Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
- Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-[L])1 inhibitor.
- Participants who progress \>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.
- Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
- Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or...
- Participants must have platinum sensitive ovarian cancer.
- Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those...
- Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including...
- Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
- Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy.
- Participants must either have ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding...
- NSCLC.
- Age 18 to 65 years (inclusive).
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Measurable disease per the RECIST version 1.1 at baseline.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at...
- Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate. Note: Other protocol-defined inclusion/exclusion may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Santa Barbara, California, United States
- Santa Rosa, California, United States
- Fort Myers, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Augusta, Georgia, United States
- Westwood, Kansas, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Maplewood, Minnesota, United States
- Camden, New Jersey, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Eugene, Oregon, United States
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; Santa Barbara, California, United States; Santa Rosa, California, United States and 55 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.