What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy and immunotherapy, have well-documented side effects. Chemotherapy agents like cisplatin, doxorubicin, and paclitaxel can cause nausea, vomiting, hair loss, fatigue, myelosuppression (increasing infection risk), and peripheral neuropathy. Immunotherapy, including PD-1/PD-L1 inhibitors like nivolumab and pembrolizumab, can lead to immune-related adverse events such as colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions. These treatments require careful monitoring to manage side effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, focusing on antitumor activity. Notable approvals include pembrolizumab, an anti-PD-1 therapy, for various cancers such as melanoma and non-small cell lung cancer, and nivolumab, another anti-PD-1 therapy, often used in combination with ipilimumab for renal cell carcinoma. Additionally, targeted therapies like vemurafenib for BRAF-mutated melanoma and lutetium Lu 177 vipivotide tetraxetan for PSMA-positive metastatic castration-resistant prostate cancer have shown significant efficacy. These treatments highlight the FDA's focus on immunotherapies and targeted therapies for solid tumors.

What other types of research exist?

Promising novel alternatives to UCT-01-097 for solid tumor patients in 2024 include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, which has shown efficacy in various solid tumors such as non-small cell lung cancer (NSCLC) and renal cell carcinoma. 2) Atezolizumab (Tecentriq) in combination with bevacizumab and chemotherapy, particularly for NSCLC and renal cell carcinoma. 3) Nivolumab (Opdivo) plus ipilimumab (Yervoy), which has demonstrated effectiveness in melanoma, renal cell carcinoma, and mesothelioma. 4) Cabozantinib combined with atezolizumab, which has shown promise in advanced renal cell carcinoma. These therapies have been supported by recent clinical trials and are expected to be significant options in 2024.

← Back to Search

Other

UCT-01-097 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by 1200 Pharma, LLC

Eligibility Criteria Checklist

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

Must have

Advanced solid tumor

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

Must not have

Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial tests a new drug called UCT-01-097 on patients with advanced solid tumors to see if it is safe, how it behaves in the body, and if it can help fight cancer.

Who is the study for?

This trial is for adults with advanced solid tumors who have measurable disease, are in good physical condition (ECOG 0-1), and have proper organ function. It's not for those with brain metastases, serious medical conditions, calcium/phosphate disorders, significant heart disease, retinopathy risk, recent cancer history except certain skin cancers or low-risk malignancies.

What is being tested?

The study tests UCT-01-097's safety and effectiveness against advanced solid tumors. Participants will also receive standard chemotherapy drugs like Paclitaxel or Gemcitabine to see how well they work together.

What are the potential side effects?

Possible side effects include reactions to the infusion of UCT-01-097 or chemotherapy drugs such as fatigue, nausea, hair loss (alopecia), blood cell count changes leading to increased infection risk or bleeding problems. Organ-specific inflammation might occur.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am fully active or can carry out light work.

Exclusion Criteria

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

Select...

I still have side effects from previous treatments, except for hair loss.

Select...

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

Select...

I am not pregnant or breastfeeding.

Select...

I have a history of serious heart problems.

Select...

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

Select...

I have had issues with my phosphate or calcium levels.

Select...

My brain cancer is getting worse or causing symptoms.

Select...

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

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)

Accumulation Ratio (Rac) of UCT-01-097

+13 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

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

Group II: Dose Finding in Combination - Part 3Experimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

FDA approved

Paclitaxel

FDA approved

0 / 10Eligibility 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, immunotherapy, and targeted therapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells. Immunotherapy boosts the immune system to recognize and attack cancer cells, while targeted therapy focuses on specific genetic mutations or proteins that drive cancer growth. These mechanisms are important for solid tumor patients as they help tailor treatments to the tumor's specific characteristics, improving effectiveness and reducing side effects.

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