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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: UCT-01-097; Drug: Gemcitabine; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Stephen Letrent, PharmD, PhD; Phone Number: 858-342-6652; Email: stephen.letrent@1200pharma.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA - JCCC Clinical Research Unit
    • Torrance, California, United States, 90505
      • Torrance Memorial
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Institute of Emory University
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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-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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Finding as Monotherapy - Part 1	Drug: UCT-01-097; Orally available kinase inhibitor
Experimental: Expansion as Monotherapy - Part 2	Drug: UCT-01-097; Orally available kinase inhibitor
Experimental: Dose Finding in Combination - Part 3	Drug: UCT-01-097; Orally available kinase inhibitor; Drug: Gemcitabine; Gemcitabine injection for intravenous use.; Other Names: Gemzar; Drug: Paclitaxel; Paclitaxel protein-bound particles for injectable suspension (albumin-bound).; Other Names: Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 2 years
Time to Response (TTR)	Time from start of treatment to complete response or partial response	up to 2 years
1 Year Overall Survival (1YOS)	Proportion of participants alive at 1 year from the start of treatment to death from any cause	1 year
2 Year Overall Survival (2YOS)	Proportion of participants alive at 2 years from the start of treatment to death from any cause	2 years
Maximum Plasma UCT-01-097 Concentration (Cmax)	PK assessment for UCT-01-097	Day 1
Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss)	PK assessment for UCT-01-097	Day 15
UCT-01-097 Trough Plasma Concentration (Cmin)	PK assessment for UCT-01-097	Day 1
UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss)	PK assessment for UCT-01-097	Day 15
Time of Maximum Plasma UCT-01-097 Concentration (Tmax)	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-01-097	PK assessment for UCT-01-097	Day 15
Apparent Clearance (CL/F) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Apparent Volume of Distribution (Vz/F) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Accumulation Ratio (Rac) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Terminal Half-life (t1/2) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Objective Response Rate (ORR)	Percentage of participants with best response of CR or PR according to RECIST 1.1	up to 2 years
Duration of Response (DOR)	Time from complete response or partial response to objective disease progression or death due to any cause	up to 2 years

Collaborators and Investigators

• Sponsor: 1200 Pharma, LLC
• Investigators: Study Director: Stephen Letrent, PharmD, PhD, 1200 Pharma, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Gemcitabine
• Other Study ID Numbers: UCT01097-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No