- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06060613
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective (Phase 1):
• Assess the safety and tolerability of OBX-115 regimen
Primary Objective (Phase 2):
• Evaluate preliminary efficacy of OBX-115 regimen as measured by the investigator using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary (Phase 1):
• Assess preliminary efficacy of OBX-115 regimen by evaluating ORR
Secondary (Phase 2):
• Evaluate safety and tolerability of OBX 115 based on the collected AE data
Secondary (both Phase 1 and Phase 2):
- Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to cancer.
- Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by the investigator.
- Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause.
- Evaluate overall survival (OS): To evaluate the time from the date of OBX-115 infusion to death due to any cause
- Evaluate feasibility of the manufacturing process: Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Obsidian Therapeutics
- Phone Number: 781-202-5423
- Email: OBX115-2301TRIAL@OBSIDIANTX.COM
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32806
- Recruiting
- Orlando Health Cancer Institute (Melanoma)
-
Principal Investigator:
- Sajeve Thomas, MD
-
Contact:
- Estefania Bobe Cortes
- Email: Estefania.BobeCortes@orlandohealth.com
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- James Graham Brown Cancer Center (Melanoma/NSCLC)
-
Contact:
- Melissa B. Hall
- Email: Mmbaro01@louisville.edu
-
Principal Investigator:
- Jason Chesney, MD, PhD
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering (Melanoma/NSCLC)
-
Principal Investigator:
- Alexander Shoushtari, MD
-
Contact:
- Melanoma
- Phone Number: 646-497-9067
-
Contact:
- NSCLC
- Phone Number: 6464979163
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- Allegheny Research Institute
-
Principal Investigator:
- Yazan Samhouri, MD
-
Contact:
- Lindsay Brown
- Email: lindsey.brown@ahn.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 ore relapsed refractory metastatic non-small cell lung cancer (NSCLC).
- Melanoma participant 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. If the tumor is BRAF V600 mutation-positive, the participant should also have received a BRAF inhibitor with or without a MEK inhibitor. 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).
- 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 >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.
Exclusion Criteria:
- Participant has melanoma of uveal origin.
- Participant has a history of brain metastases or leptomeningeal disease.
- 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 unegineered TIL cell therapy is allowed.
- Participant requires systemic steroid therapy >10 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants with advanced solid tumors
Participants will receive conditioning therapy prior to administration of OBX-115 regimen.
|
A tumor sample is obtained from each participant for autologous OBX-115 manufacture. After lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by a short course of acetazolamide. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and nature of dose-limiting toxicities (DLTs)
Time Frame: 28 Days
|
• Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).
|
28 Days
|
The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
Time Frame: 2 years
|
• The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of AEs
Time Frame: 2 years
|
• Incidence of treatment-emergent adverse events (TEAEs), including SAEs, study intervention related AEs, and AEs leading to early discontinuation of study intervention or withdrawal from the Assessment Period or death up to 2 years after initiation of study intervention
|
2 years
|
The proportion of participants who have a confirmed CR or PR per RECIST v1.1
Time Frame: 2 years
|
• The proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 1)
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Skin Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Melanoma
Other Study ID Numbers
- OBX115-23-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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