Tumor SkinPhase 1/2Agni-01NCT06060613
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
A Phase 1/2 study testing OBX-115 in people with Tumor Skin and Metastatic Melanoma, run by Obsidian Therapeutics, Inc. at 10 sites in 2 countries.
Trial summary
This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Skin, Metastatic Melanoma, Melanoma
- What is being tested?
- OBX-115
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 25 Oct 2023to 30 Jun 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 or relapsed refractory metastatic non-small cell lung cancer (NSCLC).
- Cohort and indication specific criteria as follows:
- 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.
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- 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).
- Participants who received PD-1/PD-L1 inhibitor-based therapy in the adjuvant or neoadjuvant setting and whose disease relapsed or progressed to metastatic disease within 6 months of their last systemic PD-1/PD-L1 treatment are eligible without requiring additional treatment in the metastatic setting.
- Participants who experienced disease progression following a prior cytotoxic chemotherapy-based regimen may have received no more than one additional chemotherapy-containing regimen. However, participants must not have had disease progression while receiving this second-chemotherapy containing regimen.
- 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 (neo)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.
- 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 prior to tumor procurement.) 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 (neo)adjuvant treatment (primary ICI resistant) are not eligible.
- 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.
Who cannot join
- 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 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.
- 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.
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- 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.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States9 sites, 8 recruiting
- Active, not recruiting
The Ohio State University
Columbus, Ohio, 43210
- Recruiting
M.D. Anderson Cancer Center (Melanoma/NSCLC)
Houston, Texas, 77030
Steffy Jose, SJose3@mdanderson.org
Rodabe Amaria, MD
- Recruiting
The Angeles Clinic and Research Institute (Melanoma)
Los Angeles, California, 90025
Saba Mukarram, SMukarram@theangelesclinic.org
Omid Hamid, MD
- Recruiting
USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)
Los Angeles, California, 90033
Sandy Tran, 323-865-3935, sandy.tran@med.usc.edu
Gino In, MD
- Recruiting
James Graham Brown Cancer Center (Melanoma/NSCLC)
Louisville, Kentucky, 40202
Melissa B. Hall, Mmbaro01@louisville.edu
Jason Chesney, MD, PhD
- Recruiting
Memorial Sloan Kettering (Melanoma/NSCLC)
New York, New York, 10065
Melanoma, 6464979067
NSCLC, 6464979163
- Recruiting
Orlando Health Cancer Institute (Melanoma/NSCLC)
Orlando, Florida, 32806
Danielle Ramos, 321-841-6764, danielle.ramos1@orlandohealth.com
Tirrell T. Johnson, MD
- Recruiting
Allegheny Research Institute (Melanoma/NSCLC)
Pittsburgh, Pennsylvania, 15224
Lindsay Brown, lindsey.brown@ahn.org
Deanna Huffman, DO
- Recruiting
Stanford Cancer Institute (Melanoma/NSCLC)
Stanford, California, 94305
Samantha Lam, 650-736-3054, samalam@stanford.edu
Allison Betof, MD
Australia1 site, 1 recruiting
- Recruiting
Melanoma Institute of Australia
Wollstonecraft, New South Wales, 2065
Raina Faraz, Rania.Faraz@melanoma.org.au
Georgina Long, MD
About this study
Official title: 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
This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
Read the 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 Blinded Independent Central Review (BICR) using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Cohort 3)
- 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 (Cohorts 1, 2, 4)
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 BICR until disease progression or death due to cancer (Phase 2 Cohort 3).
- 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 (Phase 1 and Phase 2 Cohorts 1, 2, and 4).
- 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 BICR (Phase 2 Cohort 3).
- 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 (Phase 1 and Phase 2 Cohorts 1, 2, and 4).
- 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 BICR or death due to any cause (Phase 2 Cohort 3).
- 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 (Phase 1 and Phase 2 Cohorts 1, 2, and 4).
- 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.
- Conditions
- Tumor Skin, Metastatic Melanoma, Melanoma, Lung Cancer, Metastatic Lung Cancer, Non Small Cell Lung Cancer
- Being tested
- OBX-115
- Keywords
- Adoptive cell therapy, Tumor Infiltrating Lymphocytes, TIL, Melanoma, Lung Cancer
- Medical subject headings
- Skin Neoplasms, Melanoma, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBX-115Biological
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 short courses of acetazolamide.
| Study group | Role | What they receive |
|---|---|---|
| Participants with advanced solid tumors | Experimental | Participants will receive conditioning therapy prior to administration of OBX-115 regimen. Receives: Biological: OBX-115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose-limiting toxicities (DLTs)
- Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).
Measured: 28 Days
The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
- 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)
Measured: 2 years
The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
- 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)
Measured: 2 years
Secondary outcomes (2)
The proportion of participants who have a confirmed CR or PR per RECIST v1.1
- 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)
Measured: 2 years
Incidence of AEs
- 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start25 Oct 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obsidian Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060613
- Sponsor's protocol ID
- OBX115-23-01
- Acronym
- Agni-01
- Status last verified
- Jul 2026
- First submitted
- 22 Sep 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No