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Tests treatment safety and results for Tumor Skin
Official title Safety and Efficacy of OBX-115 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06060613
What this study is testing
What is OBX-115?
OBX-115 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tumor skin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be 18 years of age or older at the time of signing the informed consent.
- Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer...
- 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...
You likely can't join if
- Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
- Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain...
- 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.
See the full eligibility criteria
Who can join
- Participant must be 18 years of age or older at the time of signing the informed consent.
- 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...
- Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the...
- 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...
- Participant must not have been exposed to any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting.
- Phase 2 Cohort 3 (recruiting):
- 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...
- Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the...
- Participants with targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF/MEK inhibitor that was given as the most recent line of...
- Phase 2 Cohort 4 (recruiting):
- Participants with frontline unresectable or metastatic melanoma.
- Participants may have received up to 2 doses of system therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody-based treatment of unresectable metastatic melanoma...
- Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.
- After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.
- Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE]).
- Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.
- Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements.
- Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.
- Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.
What rules you out
- Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
- Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are that have been treated, if clinically...
- 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.
- Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.
- Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).
- Participant has evidence of positive infectious disease screening and/or any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Stanford, California, United States
- Orlando, Florida, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Wollstonecraft, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Stanford, California, United States; Orlando, Florida, United States; Louisville, Kentucky, United States; New York, New York, United States; Columbus, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.