RECRUITING

Rinatabart Sesutecan (Rina-S) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

Talk to us

Conditions

Platinum-Resistant Ovarian CancerPlatinum Sensitive Ovarian Cancer (PSOC)High Grade Epithelial Ovarian CancerHigh Grade Serous Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CancerEndometrial CancerNon-small Cell Lung CancerEpidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)MesotheliomaBreast AdenocarcinomaTriple Negative Breast CancerHormone Receptor-positive/Her2 Negative Breast Cancerantibody-drug conjugatefolate receptor alphafolate receptorsolid tumorovarian cancerbreast cancerhormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancertopoisomerase I inhibitorPROCepidermal growth factor receptor (EGFR)-mutated NSCLC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Official Title

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors

Quick Facts

Study Start:2022-12-07
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05579366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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 cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma.
  2. * Previously received therapies known to confer clinical benefit.
  3. * Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.
  4. * 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)
  5. * Participants must have received 1 to 3 prior lines of therapy. Participants who had 1 to 4 prior lines of therapy are allowed if mirvetuximab soravtansine (MIRV) was the last line of therapy.
  6. * Participants must have platinum-resistant ovarian cancer.
  7. * Participants must have received prior bevacizumab.
  8. * 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 laboratory) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.
  9. * Participants must have known FRα status based on an FDA approved test. Those who are FRα positive must have previously received MIRV, unless the participant has a documented medical exception.
  10. * Prior induction plus maintenance is considered 1 line of therapy, even if parts of the treatment regimen (induction or maintenance) are interrupted and/or resumed at a later date, in the absence of disease progression while on active treatment.
  11. * A switch/change in regimen due solely to toxicity or participant preference (and not disease progression) is not considered a separate line of therapy.
  12. * Participants must have platinum-sensitive ovarian cancer.
  13. * Participants must have received 1 to 3 prior lines of therapy.
  14. * Participants must have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
  15. * 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). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.
  16. * Endometrial cancer (any subtype excluding sarcoma).
  17. * Participants must have received prior platinum-based chemotherapy for recurrent or advanced disease.
  1. * 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 screening.
  2. * Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 14 days (dose escalation only).
  3. * Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Contacts and Locations

Study Contact

Genmab Trial Information
CONTACT
+4570202728
clinicaltrials@genmab.com

Principal Investigator

Study Official
STUDY_DIRECTOR
Genmab

Study Locations (Sites)

USOR HonorHealth
Phoenix, Arizona, 85016
United States
USOR Arizona Oncology Associates
Tucson, Arizona, 85711
United States
University of California Los Angeles Medical Center 106
Los Angeles, California, 90095
United States
University of California, San Diego; Moores Cancer Center
San Diego, California, 92093
United States
USOR Sansum Clinic
Santa Barbara, California, 93105
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
USOR Florida Cancer Specialists South
Fort Myers, Florida, 33908
United States
USOR Florida Cancer Specialists North
Saint Petersburg, Florida, 33709
United States
USOR Florida Cancer Specialists East
West Palm Beach, Florida, 33401
United States
University of Kansas Medical Center (KUMC)
Westwood, Kansas, 66205
United States
USOR Maryland Oncology Hematology
Rockville, Maryland, 20850
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48085
United States
START Midwest
Grand Rapids, Michigan, 49503
United States
USOR Minnesota Oncology Hematology
Maplewood, Minnesota, 55109
United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
USOR Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
United States
Compass Oncology - Rose Quarter
Portland, Oregon, 97227
United States
Compass Oncology- Rose Quarter
Portland, Oregon, 97227
United States
USOR Alliance Cancer Specialist
Doylestown, Pennsylvania, 18901
United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203
United States
USOR Texas Oncology
Abilene, Texas, 79606
United States
Texas Oncology - Central / South Texas
Austin, Texas, 78758
United States
Texas Oncology- Central/South Texas
Austin, Texas, 78758
United States
Mary Crowley Cancer Research
Dallas, Texas, 75521
United States
USOR Texas Oncology
Fort Worth, Texas, 76104
United States
Texas Oncology - Northeast TX
Tyler, Texas, 75702
United States
Texas Oncology-Northeast TX
Tyler, Texas, 75702
United States
USOR Texas Oncology Gulf Coast
Woodland, Texas, 77380
United States
START Mountain Region
West Valley City, Utah, 84119
United States
USOR Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
USOR Virginia Oncology Associates
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: Genmab

  • Study Official, STUDY_DIRECTOR, Genmab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-07
Study Completion Date2026-10

Study Record Updates

Study Start Date2022-12-07
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • antibody-drug conjugate
  • folate receptor alpha
  • folate receptor
  • solid tumor
  • ovarian cancer
  • primary peritoneal carcinoma
  • fallopian tube cancer
  • endometrial cancer
  • non-small cell lung cancer
  • mesothelioma
  • breast cancer
  • triple negative breast cancer
  • hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
  • topoisomerase I inhibitor
  • PROC
  • epidermal growth factor receptor (EGFR)-mutated NSCLC

Additional Relevant MeSH Terms

  • Platinum-Resistant Ovarian Cancer
  • Platinum Sensitive Ovarian Cancer (PSOC)
  • High Grade Epithelial Ovarian Cancer
  • High Grade Serous Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Cancer
  • Endometrial Cancer
  • Non-small Cell Lung Cancer
  • Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)
  • Mesothelioma
  • Breast Adenocarcinoma
  • Triple Negative Breast Cancer
  • Hormone Receptor-positive/Her2 Negative Breast Cancer