Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Key Inclusion Criteria:
• Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
• Participant must have radiological disease progression while on or after receiving the most recent regimen.
• Participants either may have actionable genetic alterations (AGAs) or no AGAs.
• Participant has measurable disease according to RECIST v1.1.
• Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.
• Key Exclusion Criteria (all study cohorts):
• Participant has NSCLC with histology other than adenocarcinoma
• Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
• Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.
• Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

anti-FRalpha/exatecan ADC PRO1184. An antibody-drug conjugate (ADC) composed of a human monoclonal antibody targeting folate receptor alpha (FRa; FolRa; FOLR1) conjugated, via a cleavable hydrophilic linker, to the camptothecin analog and topoisomerase 1 inhibitor exatecan, with potential antineoplastic activity. Upon administration of anti-FRalpha/exatecan ADC PRO1184, the antibody moiety targets and binds to FRa expressed on tumor cells. Upon binding, cellular uptake and linker cleavage, exatecan is released. Exatecan inhibits DNA topoisomerase I activity, thereby inhibiting DNA replication and generating DNA single- and double-strand breaks, and leading to cell cycle arrest and tumor cell apoptosis. This inhibits the proliferation of FRa-expressing tumor cells. FRa is a glycosylphosphatidylinositol linked cell-surface glycoprotein that is widely expressed in certain cancers while its expression is limited in normal tissues. NCI Drug Dictionary

Treatments listed in the registry

• Rina-S (Drug): Intravenous (IV) infusion.

Na · Single Group · masking: None

Main goals

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator (Approximately 3 years)

Other goals

• Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator
• Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator
• Progression-free Survival (PFS)
• Overall Survival (OS)
• Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes
• Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes
• Number of Participants with Antidrug Antibodies (ADAs)
• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Planned enrollment: 240 (estimated).

• Compassionate Cancer Care Center, Fountain Valley, California
• City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California
• Kaiser Permanente San Diego Mission Road, San Diego, California
• Providence Medical Foundation (St. Joseph Heritage Healthcare), Santa Rosa, California
• MedStar Georgetown University Hospital, Washington D.C., District of Columbia
• University of Miami Hospital, Miami, Florida
• Moffitt Cancer Center and Research Institute, Tampa, Florida
• Emory Winship Cancer Institute, Atlanta, Georgia
• St. Vincent Frontier Cancer Center, Billings, Montana
• Nebraska Hematology-Oncology, Lincoln, Nebraska
• Astera Cancer Care, East Brunswick, New Jersey
• ONE Onc: New York Oncology Hematology, Albany, New York
• Montefiore Medical Park, The Bronx, New York
• UNC Health - University of North Carolina, Chapel Hill, North Carolina
• Williamette Valley Cancer Institute and Research Center, Eugene, Oregon
• Providence Portland Medical Center, Portland, Oregon
• Providence Oncology & Hematology Care Clinic - Westside, West Haven-Sylvan, Oregon
• Tennessee Oncology - Nashville St. Thomas Midtown Clinic, Nashville, Tennessee
• Tennessee Oncology Nashville - SCRI Oncology Partners, Nashville, Tennessee
• Baylor Charles A. Sammons Cancer Center, Dallas, Texas
• Virginia Cancer Specialists, Fairfax, Virginia

70 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07288177
• NCI Drug Dictionary: C192818

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 5, 2026. Public record; not medical advice.