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Advanced Solid TumorPhase 1NCT05103046

First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors

A Phase 1 study testing UCT-03-008 in people with Advanced Solid Tumor, run by 1200 Pharma, LLC at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 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-03-008
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
5 sitesUnited States
Study dates
23 Dec 2021to 15 Dec 2025
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-03-008
  • Progressive or symptomatic brain metastases
  • Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
  • History of significant cardiac disease
  • History or current evidence/risk of retinopathy
Show all 9Show fewer
  • 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

5 sites in 1 country.

Alex Garcia contact

213-5197493

AGarcia@trio-us.org

5 sites in 1 country

United States5 sites, 2 recruiting

  • Winship Institute of Emory University

    Atlanta, Georgia, 30322

    Terminated

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

    Minal Barve, MD, 972-566-3000

    Recruiting

  • UCLA - JCCC Clinical Research Unit

    Los Angeles, California, 90095

    Jonathan Goldman, MD, 310-923-8712

    Recruiting

  • START (South Texas Accelerated Research Therapeutics)

    San Antonio, Texas, 78229

    Terminated

  • Torrance Memorial

    Torrance, California, 90505

    Terminated

Other trials in United States

About this study

Official title: A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.

Being tested
UCT-03-008

What participants receive

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

  • UCT-03-008Drug

    Orally available kinase inhibitor

Study groups in NCT05103046
Study groupRoleWhat they receive
Dose Finding as Monotherapy - Part 1ExperimentalUCT-03-008 Dose Finding
Receives: Drug: UCT-03-008
Expansion as Monotherapy - Part 2ExperimentalUCT-03-008 RP2D Expansion
Receives: Drug: UCT-03-008

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 (17)

  1. Maximum Plasma UCT-03-008 Concentration following single dose (Cmax)

    PK assessment for UCT-03-008

    Measured: Cycle 0(each cycle is 28 days)

  2. Maximum Plasma UCT-03-008 Concentration at steady state (Cmax,ss)

    PK assessment for UCT-03-008

    Measured: Cycle 1 (each cycle is 28 days)

  3. Minimum Plasma UCT-03-008 Concentration following single dose (Cmin)

    PK assessment for UCT-003-008

    Measured: Cycle 0 (each cycle is 28 days)

  4. Minimum Plasma UCT-03-008 Concentration at steady state (Cmin,ss)

    PK assessment for UCT-003-008

    Measured: Cycle 1 (each cycle is 28 days)

  5. Time of Maximum Plasma UCT-03-008 Concentration following single dose (Tmax)

    PK assessment for UCT-03-008

    Measured: Cycle 0 (each cycle is 28 days)

  6. Time of Maximum Plasma UCT-03-008 Concentration at steady state (Tmax,ss)

    PK assessment for UCT-03-008

    Measured: Cycle 0 (each cycle is 28 days)

  7. Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-03-008

    PK assessment for UCT-03-008

    Measured: Cycle 0 (each cycle is 28 days)

  8. Area Under the Plasma Concentration-Time Curve from the time of dosing to the last measurable concentration (AUClast) of UCT-03-008

    PK assessment for UCT-03-008

    Measured: Cycle 0 (each cycle is 28 days)

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

    PK assessment for UCT-03-008

    Measured: Cycle 0 (each cycle is 28 days)

  10. Apparent Volume of Distribution (Vz/F) of UCT-03-008

    PK assessment for UCT-03-008

    Measured: Cycle 0 (each cycle is 28 days)

  11. Terminal Half-life (t1/2) of plasma UCT-03-008

    PK assessment for UCT-03-008

    Measured: Cycle 1 (each cycle is 28 days)

  12. Objective Response Rate (ORR)

    Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1

    Measured: up to 2 years

  13. Time to Response (TTR)

    Time from start of treatment to complete response or partial response

    Measured: up to 2 years

  14. 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

  15. 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

  16. 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

  17. 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 posted2 Nov 2021
  2. Study start23 Dec 2021
  3. Primary completion15 Dec 2024 (estimated)
  4. Study completion15 Dec 2025 (estimated)

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
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05103046
Sponsor's protocol ID
UCT03008-001
Status last verified
Mar 2024
First submitted
21 Oct 2021
Last updated
12 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-03-008 in people with Advanced Solid Tumor, run by 1200 Pharma, LLC at 5 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 9 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: status not confirmed, as of the sponsor's last update on 12 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 5 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?

Results are not available in the source record.

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

Contact Alex Garcia (213-5197493, AGarcia@trio-us.org), or a site near the patient. 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 NCT05103046.

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 12 Mar 2024.

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