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OBX-115 for Advanced Solid Tumors

This study is testing a treatment called OBX-115 for adults with advanced melanoma (a type of skin cancer) or advanced non-small cell lung cancer. Researchers want to see how safe OBX-115 is and if it can shrink tumors. To participate, a tumor sample will be taken from you to create your personalized OBX-115 treatment. You will then receive OBX-115 after a preparation treatment with cyclophosphamide and fludarabine, followed by short courses of acetazolamide. The study will measure how many participants have their tumors shrink or disappear completely. There are 208 participants planned for this study.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 208 participants.
What's involved
You will have a tumor sample taken to create your personalized OBX-115. You will then receive a preparation treatment (lymphodepletion) followed by the OBX-115 infusion and short courses of acetazolamide.
Compensation
Not stated in the trial record.
Follow-up
The study will track your response to treatment for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06060613

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Obsidian Therapeutics, Inc.
~208 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:OBX-115

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and nature of dose-limiting toxicities (DLTs)
Measured over 28 Days
+2 more outcomes measured

Conditions

Tumor Skin
Metastatic Melanoma
Melanoma
Lung Cancer
Metastatic Lung Cancer
Non Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer

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Where it's being run

10 sites across 8 states
California3
Florida1
Kentucky1
New York1
Ohio1
Pennsylvania1
Texas1
New South Wales1

Who to contact

Obsidian Therapeutics
[email protected]
781-202-5423
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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. 2. 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).
Participant must not have been exposed to any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting. 3. 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 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 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 therapy. 4. 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 (but must not have known clinical progression.) Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy; however, participants whose disease progressed within 12 weeks after the last dose of the PD-1/PD-L1 blocking antibody given as adjuvant treatment (primary ICI resistant) are not eligible. 4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation. 5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1. 6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months. 7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\]). 8. 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. 9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements. 10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count. 11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.

What this trial measures

  • Incidence and nature of dose-limiting toxicities (DLTs)28 Days

    • Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).

  • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.12 years

    • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR) 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 Cohort 3)

  • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.12 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 Cohort 1, 2, and 4)