Home › Trials › NCT06060613

Investigating OBX-115 for 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

Phase1; Phase2 Interventional Obsidian Therapeutics, Inc. · NCT06060613

This study is testing a new treatment called OBX-115 to see if it can help adults with advanced solid tumors like metastatic melanoma and non-small cell lung cancer feel better and live longer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment208 (estimated)
Ages18 Years and up
SexAll
SponsorObsidian Therapeutics, Inc. Industry-sponsored
Drugs / interventionschemotherapy, prednisone
Locations9 sites (Los Angeles, California and 8 other locations)
Trial IDNCT06060613 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of the OBX-115 regimen in adult patients with advanced solid tumors, specifically metastatic melanoma and non-small cell lung cancer. The trial is divided into two phases, with Phase 1 focusing on safety and tolerability, while Phase 2 assesses preliminary efficacy based on objective response rates. Secondary objectives include evaluating the duration of response, disease control rate, progression-free survival, and overall survival. The study also aims to assess the feasibility of the manufacturing process for OBX-115.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic melanoma or relapsed refractory non-small cell lung cancer.

Not a fit: Patients who have not experienced disease progression after prior systemic therapies or those with early-stage tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies using adoptive cell therapy approaches have shown promise, indicating potential for success with this novel treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant must be 18 years of age or older at the time of signing the informed consent.
2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).
3. Cohort and indication specific criteria as follows:

   1. 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 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.

Exclusion Criteria:

1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
2. 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 indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor.
3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.
4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.
5. Participant has any form of primary or acquired immunodeficiency.
6. Participant has a history of hypersensitivity to any component of the study intervention.
7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).
8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.
9. Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.
10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).
11. 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.

Where this trial is running

Los Angeles, California and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Tumor SkinMetastatic MelanomaMelanomaLung CancerMetastatic Lung CancerNon Small Cell Lung CancerMetastatic Non Small Cell Lung CancerAdoptive cell therapy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.