Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
This is a study to investigate the safety and how well it works of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are OBX-115. The registry lists allocation as na. This is a study to investigate the safety and how well it works of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
They plan to enroll about 254 people at 14 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors
Interventions: OBX-115
Primary outcome (registry wording): Incidence and nature of dose-limiting toxicities (DLTs)
Who it is for (from inclusion criteria)
Ages 18 Years to any
Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC)
Cohort and indication specific criteria as follows:
Phase 1 and Phase 2 Cohort 1 (enrollment complete):
Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody
Phase 1 and Phase 2 Cohort 2 (recruiting):
Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease)
Phase 2 Cohort 3 (recruiting):
Who the registry excludes
Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ)
Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation
Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions
Participant has any form of primary or acquired immunodeficiency
Participant has a history of hypersensitivity to any component of the study intervention
Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions)
Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed
Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06060613?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06060613?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.