What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as those involving antitumor agents like paclitaxel, cisplatin, and etoposide, often result in a range of side effects. These can include myelosuppression (leading to anemia, leukopenia, and thrombocytopenia), gastrointestinal issues (nausea, vomiting, diarrhea), neuropathy, alopecia, and mucositis. Additionally, patients may experience fatigue, increased risk of infections, and organ-specific toxicities such as nephrotoxicity with cisplatin and cardiotoxicity with certain other agents. Managing these side effects is crucial for maintaining patient quality of life during treatment.

What prior FDA approvals exist?

Several antitumor agents have received FDA approval for the treatment of solid tumors. Pembrolizumab, an anti-PD-1 therapy, has been approved for various cancers, including melanoma and non-small cell lung cancer, due to its ability to enhance the immune system's response against tumor cells. Similarly, nivolumab, another anti-PD-1 agent, has shown efficacy in treating cancers like melanoma and renal cell carcinoma. Additionally, combination therapies such as pembrolizumab plus cetuximab are being investigated for head and neck cancers. These treatments, which focus on immune checkpoint inhibition, are similar in their antitumor approach to the investigational agent UCT-03-008 being studied for advanced solid tumors.

What other types of research exist?

Promising novel alternatives to UCT-03-008 for solid tumor patients include: 1) Pembrolizumab combined with Bevacizumab, which has shown efficacy in advanced renal cell carcinoma. 2) Nivolumab and Ipilimumab combination therapy, which has been effective in various solid tumors including renal cell carcinoma. 3) Cabozantinib combined with Atezolizumab, which has demonstrated positive results in advanced renal cell carcinoma. These therapies have shown promising results in clinical trials and may be viable options for solid tumor patients in 2024.

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UCT-03-008 for Advanced Solid Cancers

Phase 1

Recruiting

Research Sponsored by 1200 Pharma, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Advanced solid tumor

Must not have

Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection

History of significant cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called UCT-03-008 in patients with advanced cancers that have spread. The goal is to see if the drug is safe, how it behaves in the body, and if it can help fight the cancer.

Who is the study for?

This trial is for adults with advanced solid tumors that can be measured, who are in fairly good health (able to perform daily activities without significant assistance), and have their major organs working well. Pregnant or breastfeeding women, those not recovered from previous cancer treatments, or anyone who has had certain treatments within the last 14-28 days cannot join.

What is being tested?

The study is testing UCT-03-008's safety and how well it works against advanced solid tumors. It will also look at how the body processes the drug. This is the first time humans are being given this treatment to see if it could be a new option for tumor therapy.

What are the potential side effects?

Since this is a first-in-human study of UCT-03-008, specific side effects aren't yet known but may include typical reactions such as nausea, fatigue, allergic responses or more serious complications depending on how the drug affects different people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is in an advanced stage and not just in one place.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious, uncontrolled illnesses or infections.

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I have a history of serious heart problems.

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I have or am at risk for eye damage affecting my retina.

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I have a history of myelodysplastic syndrome or acute myeloid leukemia.

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My brain cancer is getting worse or causing symptoms.

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I am not pregnant or breastfeeding.

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 severity of adverse events and serious adverse events

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

1 Year Overall Survival (1YOS)

2 Year Overall Survival (2YOS)

Apparent Clearance (CL/F) of UCT-03-008

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention

UCT-03-008 RP2D Expansion

Group II: Dose Finding as Monotherapy - Part 1Experimental Treatment1 Intervention

UCT-03-008 Dose Finding

0 / 8Eligibility 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 solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by targeting rapidly dividing cells, thereby killing cancer cells but also affecting normal cells, which can lead to side effects. Targeted therapy involves drugs designed to specifically target molecular pathways essential for tumor growth and survival, minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells, often by inhibiting checkpoints that prevent immune activation. These mechanisms are crucial for solid tumor patients as they offer different approaches to halt tumor progression, potentially leading to better outcomes and personalized treatment plans.

Current trends and future directions in the genetic therapy of human neoplastic disease.