Status:
RECRUITING
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
Lead Sponsor:
Obsidian Therapeutics, Inc.
Conditions:
Tumor Skin
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
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 ...
Eligibility Criteria
Inclusion
- 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. 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 12 weeks after the last dose of the adjuvant PD-1/PD-L1 blocking antibody. 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 must not have been exposed to both taxane and gemcitabine.
- 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.
Exclusion
- 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 up to 1.5cm in diameter that have been treated, if clinically indicated.
- 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.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06060613
Start Date
October 25 2023
End Date
June 30 2028
Last Update
August 29 2025
Active Locations (9)
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1
The Angeles Clinic and Research Institute (Melanoma)
Los Angeles, California, United States, 90025
2
USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)
Los Angeles, California, United States, 90033
3
Stanford Cancer Institute (Melanoma/NSCLC)
Stanford, California, United States, 94305
4
Orlando Health Cancer Institute (Melanoma/NSCLC)
Orlando, Florida, United States, 32806