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Advanced Solid TumorPhase 1NCT04761601

First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors

A Phase 1 study testing UCT-01-097, Gemcitabine and Paclitaxel in people with Advanced Solid Tumor, run by 1200 Pharma, LLC at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
UCT-01-097, Gemcitabine and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
6 sitesUnited States
Study dates
3 Mar 2021to 29 Feb 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced solid tumor
  • Measurable disease, per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ function

Who cannot join

  • 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
  • Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of UCT-01-097
  • Progressive or symptomatic brain metastases
  • Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
  • History of phosphate or calcium disorder
  • History of significant cardiac disease
Show all 10Show fewer
  • History or current evidence/risk of retinopathy
  • History of myelodysplastic syndrome (MDS) or AML
  • History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
  • If female, is pregnant or breastfeeding

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Winship Institute of Emory University

    Atlanta, Georgia, 30322

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • UCLA - JCCC Clinical Research Unit

    Los Angeles, California, 90095

  • Sarah Cannon

    Nashville, Tennessee, 37203

  • Torrance Memorial

    Torrance, California, 90505

Other trials in United States

About this study

Official title: A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 in patients with advanced solid tumors.

Being tested
UCT-01-097, Gemcitabine, Paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UCT-01-097Drug

    Orally available kinase inhibitor

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine injection for intravenous use.

  • PaclitaxelDrug

    Also called Abraxane

    Paclitaxel protein-bound particles for injectable suspension (albumin-bound).

Study groups in NCT04761601
Study groupRoleWhat they receive
Dose Finding as Monotherapy - Part 1ExperimentalNot described
Receives: Drug: UCT-01-097
Expansion as Monotherapy - Part 2ExperimentalNot described
Receives: Drug: UCT-01-097
Dose Finding in Combination - Part 3ExperimentalNot described
Receives: Drug: UCT-01-097; Drug: Gemcitabine; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events and serious adverse events

    Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

    Measured: up to 2 years

  2. Maximum Tolerated Dose (MTD)

    Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

    Measured: 28 Days

  3. Recommended Phase 2 Dose (RP2D)

    Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

    Measured: up to 2 years

Secondary outcomes (16)

  1. Maximum Plasma UCT-01-097 Concentration (Cmax)

    PK assessment for UCT-01-097

    Measured: Day 1

  2. Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss)

    PK assessment for UCT-01-097

    Measured: Day 15

  3. UCT-01-097 Trough Plasma Concentration (Cmin)

    PK assessment for UCT-01-097

    Measured: Day 1

  4. UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss)

    PK assessment for UCT-01-097

    Measured: Day 15

  5. Time of Maximum Plasma UCT-01-097 Concentration (Tmax)

    PK assessment for UCT-01-097

    Measured: Cycle 1 (each cycle is 28 days)

  6. Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-01-097

    PK assessment for UCT-01-097

    Measured: Day 15

  7. Apparent Clearance (CL/F) of UCT-01-097

    PK assessment for UCT-01-097

    Measured: Cycle 1 (each cycle is 28 days)

  8. Apparent Volume of Distribution (Vz/F) of UCT-01-097

    PK assessment for UCT-01-097

    Measured: Cycle 1 (each cycle is 28 days)

  9. Accumulation Ratio (Rac) of UCT-01-097

    PK assessment for UCT-01-097

    Measured: Cycle 1 (each cycle is 28 days)

  10. Terminal Half-life (t1/2) of UCT-01-097

    PK assessment for UCT-01-097

    Measured: Cycle 1 (each cycle is 28 days)

  11. Objective Response Rate (ORR)

    Percentage of participants with best response of CR or PR according to RECIST 1.1

    Measured: up to 2 years

  12. Time to Response (TTR)

    Time from start of treatment to complete response or partial response

    Measured: up to 2 years

  13. Duration of Response (DOR)

    Time from complete response or partial response to objective disease progression or death due to any cause

    Measured: up to 2 years

  14. Progression Free Survival (PFS)

    PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause

    Measured: up to 2 years

  15. 1 Year Overall Survival (1YOS)

    Proportion of participants alive at 1 year from the start of treatment to death from any cause

    Measured: 1 year

  16. 2 Year Overall Survival (2YOS)

    Proportion of participants alive at 2 years from the start of treatment to death from any cause

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start3 Mar 2021
  3. Primary completion19 Feb 2024
  4. Study completion29 Feb 2024

Why it stopped: Stopped for strategic business reasons. The decision to stop the study was not connected to any safety concerns, or new risk associated with the study product, intervention, or procedures.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04761601
Sponsor's protocol ID
UCT01097-001
Status last verified
Mar 2024
First submitted
16 Feb 2021
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UCT-01-097, Gemcitabine and Paclitaxel in people with Advanced Solid Tumor, run by 1200 Pharma, LLC at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Stopped for strategic business reasons. The decision to stop the study was not connected to any safety concerns, or new risk associated with the study product, intervention, or procedures.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events and serious adverse events (time frame: up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04761601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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