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Immunotherapy

OBX-115 for Skin Cancer (Agni-01 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Obsidian Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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. If the tumor is BRAF V600 mutation-positive, the participant should also have received a BRAF inhibitor with or without a MEK inhibitor.
After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
Must not have
Participant has a history of brain metastases or leptomeningeal disease.
Participant requires systemic steroid therapy >10 mg/day of prednisone or equivalent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment called OBX-115 for adults with advanced solid tumors. It aims to see if the treatment is safe and effective by measuring its ability to shrink tumors, control disease progression, and improve survival.

Who is the study for?
Adults with advanced melanoma resistant to immune checkpoint inhibitors can join. They must have had disease progression after specific systemic therapies, at least one resectable lesion for OBX-115 generation, and be in good health otherwise. Participants need proper organ function, an ECOG status of 0 or 1, and agree to use contraception.
What is being tested?
The trial is testing the safety and effectiveness of a new treatment called OBX-115 on adults with advanced melanoma that hasn't responded to previous treatments including PD-1/PD-L1 blockers and possibly BRAF/MEK inhibitors.
What are the potential side effects?
While not explicitly listed here, side effects are likely related to the immune system's response to OBX-115 and may include typical reactions such as fatigue, flu-like symptoms, allergic reactions or skin changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer progressed after treatment with PD-1/PD-L1 inhibitors and, if applicable, BRAF/MEK inhibitors.
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I have at least one tumor that can be measured after a biopsy.
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I can care for myself and doctors expect me to live more than 6 months.
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My blood tests meet the study's requirements for white blood cells and platelets.
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I have been diagnosed with advanced or metastatic melanoma.
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I am 18 years old or older.
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I have recovered from side effects of previous cancer treatments.
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I have at least one tumor that can be surgically removed for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer spread to my brain or its coverings.
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I need more than 10 mg/day of prednisone or a similar medication.
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I am currently being treated for an infectious disease.
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I have not received a live vaccine within the last 28 days before starting LD treatment.
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My cancer originates from the eye (melanoma).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and nature of dose-limiting toxicities (DLTs)
The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
Secondary study objectives
Incidence of AEs
The proportion of participants who have a confirmed CR or PR per RECIST v1.1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with advanced solid tumorsExperimental Treatment1 Intervention
Participants will receive conditioning therapy prior to administration of OBX-115 regimen.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for lung cancer include chemotherapy, targeted therapy, and radiation therapy. Chemotherapy works by killing rapidly dividing cancer cells, but it can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), specifically inhibit cancer cell growth by blocking molecular pathways essential for tumor development, often resulting in fewer side effects compared to chemotherapy. Radiation therapy uses high-energy rays to destroy cancer cells in a localized area. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment, balancing efficacy and quality of life.
A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.Clinical trials of tyrosine kinase inhibitors for lung cancer in China: a review.Targeted therapy for the treatment of advanced non-small cell lung cancer: a review of the epidermal growth factor receptor antagonists.

Find a Location

Who is running the clinical trial?

Obsidian Therapeutics, Inc.Lead Sponsor
~26 spots leftby Oct 2025