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

NCT ID: NCT05103046

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-23

Study Completion Date

2025-12-15

Brief Summary

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

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Finding as Monotherapy - Part 1

UCT-03-008 Dose Finding

Group Type EXPERIMENTAL

UCT-03-008

Intervention Type DRUG

Orally available kinase inhibitor

Expansion as Monotherapy - Part 2

UCT-03-008 RP2D Expansion

Group Type EXPERIMENTAL

UCT-03-008

Intervention Type DRUG

Orally available kinase inhibitor

Interventions

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UCT-03-008

Orally available kinase inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Translational Research in Oncology

OTHER

Sponsor Role collaborator

1200 Pharma, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Garcia

Role: STUDY_DIRECTOR

TRIO-US

Locations

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UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States

Site Status RECRUITING

Torrance Memorial

Torrance, California, United States

Site Status TERMINATED

Winship Institute of Emory University

Atlanta, Georgia, United States

Site Status TERMINATED

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status RECRUITING

START (South Texas Accelerated Research Therapeutics)

San Antonio, Texas, United States

Site Status TERMINATED

Countries

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United States

Central Contacts

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Alex Garcia

Role: CONTACT

213-5197493

Facility Contacts

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Jonathan Goldman, MD

Role: primary

310-923-8712

Minal Barve, MD

Role: primary

972-566-3000

Other Identifiers

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UCT03008-001

Identifier Type: -

Identifier Source: org_study_id

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