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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study a new drug to see if it is safe and works against advanced solid tumors.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events and serious adverse events
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
1 Year Overall Survival (1YOS)
2 Year Overall Survival (2YOS)
Accumulation Ratio (Rac) of UCT-01-097
+13 more

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
Paclitaxel
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

1200 Pharma, LLCLead Sponsor
1 Previous Clinical Trials
68 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy Director1200 Pharma, LLC
6 Previous Clinical Trials
438 Total Patients Enrolled

Media Library

UCT-01-097 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04761601 — Phase 1
Solid Tumors Research Study Groups: Expansion as Monotherapy - Part 2, Dose Finding as Monotherapy - Part 1, Dose Finding in Combination - Part 3
Solid Tumors Clinical Trial 2023: UCT-01-097 Highlights & Side Effects. Trial Name: NCT04761601 — Phase 1
UCT-01-097 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04761601 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Under what circumstances is UCT-01-097 typically prescribed?

"UCT-01-097 has been clinically proven to be effective in treating metastatic neoplasms, locally advanced non-small cell lung cancer and metastatic bladder cancers."

Answered by AI

Has UCT-01-097 ever been tested in a research setting before?

"UCT-01-097 was initially studied in 1997 by the City of Hope Comprehensive Cancer Center. Subsequently, 1857 trials have been completed and 1114 ongoing studies are being conducted, many located in Dallas, Texas."

Answered by AI

How risky is exposure to UCT-01-097 for individuals?

"UCT-01-097's safety and efficacy has not been thoroughly vetted yet, thus it received a rating of 1."

Answered by AI

What aims does this medical research endeavor seek to accomplish?

"Over the course of two years, this trial seeks to investigate and set a Maximum Tolerated Dose (MTD) for UCT-01-097. Secondary research goals include determining the Terminal Half-Life (t1/2), Apparent Volume of Distribution (Vz/F), and Accumulation Ratio (Rac) via pharmacokinetic assessment."

Answered by AI

How many participants has this research project enrolled?

"To carry out this medical research, 1200 Pharma LLC needs to recruit a total of 106 patients who meet the qualifications. The trial will take place in Dallas, Texas at Mary Crowley Cancer Research and UCLA - JCCC Clinical Research Unit in Los Angeles, California."

Answered by AI

Is the trial still open to enrolling participants?

"Affirmative. According to the information on clinicaltrials.gov, this research project is actively seeking participants. It was originally posted on March 3rd 2021 and updated most recently on September 8th 2022; 106 people are required from three sites in total for this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
2021. "First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04761601.
~8 spots leftby Apr 2025
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