Actively Recruiting
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
Led by Obsidian Therapeutics, Inc. · Updated on 2026-05-01
208
Participants Needed
9
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
CONDITIONS
Official Title
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing the informed consent.
- Histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).
- Participants with unresectable or metastatic melanoma must have documented disease progression after systemic therapy containing PD-1/PD-L1 blocking antibody (Cohorts 1 and 3).
- Participants with melanoma must not exceed 2 prior lines of systemic therapy; neoadjuvant/adjuvant treatment not counted unless progression within 12 weeks after last dose.
- Participants with NSCLC should have relapsed or be refractory to approved systemic therapies, without exposure to second line cytotoxic chemotherapy if previously treated in first line (Cohort 2).
- Participants with targetable BRAF mutations are not required to have received prior BRAF inhibitors and must not have progression on most recent BRAF/MEK inhibitor therapy (Cohort 3).
- Participants with frontline unresectable or metastatic melanoma may have received up to 2 doses of PD-1/PD-L1 blocking antibody-based therapy without known clinical progression (Cohort 4).
- At least one lesion suitable for OBX-115 generation.
- After tumor tissue procurement, at least one measurable lesion as defined by RECIST v1.1.
- ECOG performance status of 0 or 1 and estimated life expectancy greater than 6 months.
- Recovery from prior anticancer treatment-related adverse events to at least Grade 1.
- Completed post-operative recovery from prior surgeries with wound healing and no complications.
- Agreement to protocol specified contraceptive and/or abstinence requirements.
- Protocol specified hematologic parameters for absolute neutrophil count and platelet count.
- Adequate cardiac, liver, lung, and kidney function as specified in the protocol.
You will not qualify if you...
- Melanoma of uveal origin or genetic equivalents (e.g., GNA11 and GNAQ).
- History of brain metastases or leptomeningeal disease, except up to 4 treated brain metastatic lesions or small asymptomatic lesions as agreed by Medical Monitor.
- Active medical illnesses posing increased risks as judged by the Investigator.
- NSCLC with refractory and clinically significant pleural effusions.
- Any form of primary or acquired immunodeficiency.
- History of hypersensitivity to any component of OBX-115.
- Another primary malignancy within the previous 3 years (with exceptions).
- History of allogeneic organ transplant, cell therapy, or genetically engineered cell therapy (except prior engineered TIL cell therapy).
- Requires systemic steroid therapy greater than 10 mg/day prednisone or equivalent.
- Received live or attenuated vaccination within 28 days prior to lymphodepletion.
- Evidence of positive infectious disease screening or active uncontrolled infections requiring systemic treatment.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
The Angeles Clinic and Research Institute (Melanoma)
Los Angeles, California, United States, 90025
Actively Recruiting
2
USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)
Los Angeles, California, United States, 90033
Actively Recruiting
3
Stanford Cancer Institute (Melanoma/NSCLC)
Stanford, California, United States, 94305
Actively Recruiting
4
Orlando Health Cancer Institute (Melanoma/NSCLC)
Orlando, Florida, United States, 32806
Actively Recruiting
5
James Graham Brown Cancer Center (Melanoma/NSCLC)
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
Memorial Sloan Kettering (Melanoma/NSCLC)
New York, New York, United States, 10065
Actively Recruiting
7
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Allegheny Research Institute (Melanoma/NSCLC)
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
9
M.D. Anderson Cancer Center (Melanoma/NSCLC)
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
O
Obsidian Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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