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

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ Part A and B:

• 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.

• 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.

‣ Part C:

‣ Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.

• 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 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. Participants must have progressed radiographically on or after their most recent line of therapy.

• Participants must have platinum-resistant ovarian cancer.

• Participants must have received prior bevacizumab.

• 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.

• Measurable disease per the RECIST v1.1 at baseline.

‣ Part D:

‣ Cohort D1 (Rina-S+carboplatin):

• Participants must have platinum-sensitive ovarian cancer.

• Participants must have received 1 to 3 prior lines of therapy.

‣ Cohort D2 (Rina-S+bevacizumab):

• 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. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing 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). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.

⁃ Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\>183 days) or more from the last dose of platinum-based therapy.

‣ Cohort D3 (Rina-S+pembrolizumab):

• Endometrial cancer (any subtype excluding sarcoma).

• Participants must have received prior platinum-based chemotherapy for recurrent or advanced disease.

‣ Part F:

• Participants must have histologically or cytologically confirmed endometrial cancer as specified below.

• Advanced, recurrent, metastatic, or primary unresectable endometrial cancer (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma)

• Participants must have received 1 to 3 prior lines of therapy in advanced, recurrent, or metastatic setting, and must have progressed radiographically on or after their most recent line of 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.

• Measurable disease per the RECIST Version 1.1 at baseline.

‣ Part K (US Participants Only):

• 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 serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).

• Participants must have received 1 to 5 prior lines of therapy.

• Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.

• Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.

• Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.

• Measurable disease per the RECIST Version 1.1 at baseline.

Locations
United States
Arizona
USOR HonorHealth
RECRUITING
Phoenix
USOR Arizona Oncology Associates
RECRUITING
Tucson
California
University of California Los Angeles Medical Center
RECRUITING
Los Angeles
University of California, San Diego; Moores Cancer Center
RECRUITING
San Diego
USOR Sansum Clinic
RECRUITING
Santa Barbara
Providence Medical Foundation
RECRUITING
Santa Rosa
Florida
USOR Florida Cancer Specialists South
RECRUITING
Fort Myers
USOR Florida Cancer Specialists North
RECRUITING
St. Petersburg
USOR Florida Cancer Specialists East
RECRUITING
West Palm Beach
Kansas
University of Kansas Medical Center (KUMC)
RECRUITING
Westwood
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
USOR Maryland Oncology Hematology
RECRUITING
Rockville
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
START Midwest
RECRUITING
Grand Rapids
Minnesota
USOR Minnesota Oncology Hematology
RECRUITING
Maplewood
Oklahoma
University of Oklahoma - Health Sciences Center
RECRUITING
Oklahoma City
Oregon
USOR Oncology Associates of Oregon, P.C.
RECRUITING
Eugene
Compass Oncology - Rose Quarter
RECRUITING
Portland
Pennsylvania
USOR Alliance Cancer Specialist
RECRUITING
Doylestown
Rhode Island
Women and Infants Hospital of Rhode Island
RECRUITING
Providence
Tennessee
Sarah Cannon Research Institute at Tennessee Oncology
RECRUITING
Nashville
Texas
USOR Texas Oncology
RECRUITING
Abilene
Texas Oncology - Central / South Texas
RECRUITING
Austin
Mary Crowley Cancer Research
RECRUITING
Dallas
USOR Texas Oncology
RECRUITING
Fort Worth
Texas Oncology - Northeast TX
RECRUITING
Tyler
USOR Texas Oncology Gulf Coast
RECRUITING
Woodland
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
USOR Virginia Cancer Specialists
RECRUITING
Fairfax
USOR Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Other Locations
China
Cancer hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Hunan Cancer Hospital - Phase 1
RECRUITING
Changsha
Hunan Cancer Hospital - Thoracic Medicine Dept II
RECRUITING
Changsha
Fudan University Shanghai Cancer Center - Gynecologic Oncology
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center- Phase 1
RECRUITING
Shanghai
Contact Information
Primary
Genmab Trial Information
clinicaltrials@genmab.com
+4570202728
Time Frame
Start Date: 2022-12-07
Estimated Completion Date: 2027-09
Participants
Target number of participants: 569
Treatments
Experimental: Part A, B, C, F and K
Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, F and K.
Experimental: Part D1
Rina-S in combination with carboplatin
Experimental: Part D2
Rina-S in combination with bevacizumab
Experimental: Part D3
Rina-S in combination with pembrolizumab
Sponsors
Leads: Genmab

This content was sourced from clinicaltrials.gov

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