What side effects are associated with this type of intervention?

Common treatments for lung cancer, including chemotherapy, targeted therapy, and immunotherapy, often come with a range of side effects. Chemotherapy agents like cisplatin and etoposide can cause nausea, vomiting, fatigue, and increased risk of infection due to bone marrow suppression. Targeted therapies, such as those for EGFR or HER2 mutations, may lead to rash, diarrhea, and liver function abnormalities. Immunotherapies like durvalumab can result in immune-related adverse events, including pneumonitis, colitis, and endocrinopathies. These side effects vary in severity, with some requiring additional treatments like steroids or other immunosuppressive agents.

What prior FDA approvals exist?

Several FDA-approved treatments for lung cancer include immune checkpoint inhibitors and targeted therapies. Pembrolizumab, an anti-PD-1 therapy, has shown efficacy in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC). Trastuzumab deruxtecan, an antibody-drug conjugate, is approved for HER2-mutant NSCLC. Additionally, platinum-doublet chemotherapy regimens, often followed by targeted agents like gefitinib for specific mutations, are standard treatments. These therapies highlight the trend towards personalized and targeted approaches in lung cancer treatment.

What other types of research exist?

Promising novel alternatives for lung cancer treatment in 2024 include Furmonertinib for EGFR mutation-positive NSCLC, which has shown efficacy and an acceptable safety profile in a phase III study. Additionally, DS-6051b has demonstrated effectiveness in Japanese patients with NSCLC harboring ROS1 fusions, with a high disease control rate and good tolerance. These treatments represent potential options for lung cancer patients seeking novel therapies.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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.

0 / 13Eligibility criteria met

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.