> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/rinatabart-sesutecan-rina-s-pro1184-gen1184-for-advanced-d53666fd-8cb0-41c0-9c7c-51cafe85a0b3 > Record changed: 2026-10-13 # Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) NCT05579366 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) Participants 884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) Lead sponsor Genmab Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) Start date 2022-12-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) Number of sites 66 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Acronym** RAINFOL-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Short title** Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Official title** Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Dates **Completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **First posted** 2022-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Registry last updated** 2026-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Primary completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Start date** 2022-12-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Size and sites **Participants** 884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Planned participants** 884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Protocol amendments** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Number of sites** 66 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Lead sponsor** Genmab Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Identifiers **Registry ID** NCT05579366 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **ClinicalTrials.gov ID** NCT05579366 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Outcomes ### Primary outcomes 1. Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) \[Safety and Tolerability\] Timeframe: Through end of treatment, up to approximately 1 year. 2. Parts A, and D - Dose Limiting Toxicity (DLT) Timeframe: At the end of Cycle 1 (each cycle is 21 days) The proportion of participants experiencing DLT. 3. Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Timeframe: Through end of treatment, up to approximately 1 year. Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria. 4. Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter Timeframe: Cycles 1 to 3 (each cycle is 21 days) ### Secondary outcomes 1. Parts A, B, and D - Best Overall Response (BOR) Timeframe: Up to approximately 1 year. Participants who achieve CR or PR. Best response as assessed by the investigator per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use modified RECIST (mRECIST) v1.1. 2. Parts A, B, D, and E - ORR Timeframe: Up to approximately 1 year. Participants who achieve PR or CR per RECIST v1.1 criteria. 3. Parts A, B, and D - Disease Control Rate (DCR) Timeframe: Up to approximately 1 year. Participants who achieve stable disease, PR or CR per RECIST v1.1 criteria. 4. Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS) Timeframe: Through end of treatment, up to approximately 1 year. Time from start of treatment to first documented disease progression or death 5. Parts C, E, F, G, H, I and J - Overall survival (OS) Timeframe: Up to approximately 2 years. Time from the start of study treatment to the date of death from any cause 6. Parts A, B, C, D, E, F, H, I and J - Duration of Objective Response (DOR) Timeframe: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months. Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death 7. Parts A, B, D, and E - Peak Plasma Concentration (Cmax) for Rina-S Timeframe: Through end of treatment, up to approximately 1 year. Measurement of maximum plasma concentration after the administration of Rina-S. 8. Parts A, B, D, and E - Area Under the Plasma Concentration Versus Time Curve (AUC) for Rina-S Timeframe: Through end of treatment, up to approximately 1 year. Measurement of AUC after the administration of Rina-S. 9. Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S Timeframe: Through end of treatment, up to approximately 1 year 10. Parts A, B, D, and E - Trough Concentrations (Ctrough) for Rina-S Timeframe: Through end of treatment, up to approximately 1 year 11. Parts A, B, D, and E- Apparent Terminal Half-life (t1/2) for Rina-S Timeframe: Through end of treatment, up to approximately 1 year 12. Parts C, D, E, H and J - CA-125 Response Determined Using the Gynecologic Cancer Intergroup (GCIG) Criteria Timeframe: Through end of treatment, up to approximately 1 year 13. Parts C, E, F, H, I, J, and K - Number of Participants with Type, Incidence, Severity, Seriousness as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and Relatedness of Adverse Events (AEs) Timeframe: Through end of treatment, up to approximately 1 year 14. Part E - Number of Participants With Antidrug Antibodies (ADA) Timeframe: Through end of treatment, up to approximately 1 year Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 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 or cervical cancer (Part B). - 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, E, and H: 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 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 progressed radiographically on or after their most recent 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 laboratory; or locally approved equivalent) 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: - Participants must have platinum-sensitive ovarian cancer. - Participants must have received 1 to 3 prior lines of therapy. Cohort D2: - 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: • Endometrial cancer (any subtype excluding sarcoma). Cohort D4: • Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors). Part F and G: - 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 1 to 3 prior lines of therapy, 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 I: - 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 sarcomatous histology, mixed tumors containing any of the above histologies or low grade/borderline ovarian tumors). - Participants must have platinum sensitive ovarian cancer. - Measurable disease per the RECIST Version 1.1 at baseline. Part J: - 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 with a sarcomatous or neuroendocrine element. - Measurable disease per the RECIST Version 1.1 at baseline. Part K: - 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 primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer. - Measurable disease per the RECIST Version 1.1 at baseline. ### Exclusion criteria - 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. - Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate. Note: Other protocol-defined inclusion/exclusion may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Sites - USOR HonorHealthPhoenix, United StatesRecruiting - USOR Arizona Oncology AssociatesTucson, United StatesRecruiting - University of California Los Angeles Medical CenterLos Angeles, United StatesRecruiting - University of California, San Diego; Moores Cancer CenterSan Diego, United StatesRecruiting - USOR Sansum ClinicSanta Barbara, United StatesRecruiting - Providence Medical FoundationSanta Rosa, United StatesRecruiting - USOR Florida Cancer Specialists SouthFort Myers, United StatesRecruiting - USOR Florida Cancer Specialists NorthSt. Petersburg, United StatesRecruiting - USOR Florida Cancer Specialists EastWest Palm Beach, United StatesRecruiting - Augusta University Georgia Cancer CenterAugusta, United StatesRecruiting - University of Kansas Medical Center (KUMC)Westwood, United StatesRecruiting - USOR Maryland Oncology HematologyRockville, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesRecruiting - START MidwestGrand Rapids, United StatesRecruiting - USOR Minnesota Oncology HematologyMaplewood, United StatesRecruiting - MD Anderson Cancer Center at Cooper- Two Cooper PlazaCamden, United StatesRecruiting - Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research InstituteColumbus, United StatesRecruiting - University of Oklahoma - Health Sciences CenterOklahoma City, United StatesRecruiting - USOR Oncology Associates of Oregon, P.C.Eugene, United StatesRecruiting - Compass Oncology - Rose QuarterPortland, United StatesRecruiting - USOR Alliance Cancer SpecialistDoylestown, United StatesRecruiting - Allegheny Health NetworkPittsburgh, United StatesRecruiting - Women and Infants Hospital of Rhode IslandProvidence, United StatesRecruiting And 41 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## References ### Other registry identifiers (3) - CTR20230813 - PRO1184-001 - jRCT2051250094 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366) ## Related records ### Drugs (4) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Rinatabart sesutecan](https://trialight.com/data/asset/rinatabart-sesutecan-8c5bce0a-8a66-4f83-b6c8-f6b9dfb58e2e.md) ### Lead sponsors (1) - [Genmab](https://trialight.com/data/company/genmab-484f57db-e23b-4014-8aee-65414839b80f.md) ### Conditions (12) - [Breast adenocarcinoma](https://trialight.com/data/condition/breast-adenocarcinoma-f9475fb8-d1bd-572c-92f9-4c2f14c51af5.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Mesothelioma](https://trialight.com/data/condition/mesothelioma-49ad8bc3-59bf-506b-aa1a-b31c5d0f0e9d.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) - [Primary peritoneal carcinoma](https://trialight.com/data/condition/primary-peritoneal-carcinoma-9bb0e4b4-cb5a-5d56-8331-331c250af14d.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) - [Tumor of uterus](https://trialight.com/data/condition/tumor-of-uterus-0e35fef4-f54a-5086-aa67-9cd577110fd7.md) - [Uterine cancer](https://trialight.com/data/condition/uterine-cancer-730975f4-97de-54f6-9dc4-0ffc00bae465.md) ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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