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

NCT04761601 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: UCT01097-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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

  up to 2 years

• Maximum Tolerated Dose (MTD)

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

  28 Days

• Recommended Phase 2 Dose (RP2D)

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

  up to 2 years

Secondary Outcomes (16)

• Maximum Plasma UCT-01-097 Concentration (Cmax)

  Day 1

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

  Day 15

• UCT-01-097 Trough Plasma Concentration (Cmin)

  Day 1

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

  Day 15

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

  Cycle 1 (each cycle is 28 days)

Study Arms (3)

Dose Finding as Monotherapy - Part 1

EXPERIMENTAL

Drug: UCT-01-097

Expansion as Monotherapy - Part 2

EXPERIMENTAL

Drug: UCT-01-097

Dose Finding in Combination - Part 3

EXPERIMENTAL

Drug: UCT-01-097; Drug: Gemcitabine; Drug: Paclitaxel

Interventions

UCT-01-097 DRUG

Orally available kinase inhibitor

Dose Finding as Monotherapy - Part 1; Dose Finding in Combination - Part 3; Expansion as Monotherapy - Part 2

Gemcitabine DRUG

Gemcitabine injection for intravenous use.

Also known as: Gemzar

Dose Finding in Combination - Part 3

Paclitaxel DRUG

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

Also known as: Abraxane

Dose Finding in Combination - Part 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• 1200 Pharma, LLC: lead

Study Sites (6)

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095, United States

Location

Torrance Memorial

Torrance, California, 90505, United States

Location

Winship Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

Location

Sarah Cannon

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MeSH Terms

Interventions

Gemcitabine; Paclitaxel; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Stephen Letrent, PharmD, PhD

  1200 Pharma, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: March 3, 2021
• Primary Completion: February 19, 2024
• Study Completion: February 29, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)