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

Sponsors

Lead Sponsor: 1200 Pharma, LLC

Source 1200 Pharma, LLC
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.

Overall Status Not yet recruiting
Start Date March 1, 2021
Completion Date August 1, 2024
Primary Completion Date September 23, 2023
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence and severity of adverse events and serious adverse events up to 2 years
Maximum Tolerated Dose (MTD) 28 Days
Recommended Phase 2 Dose (RP2D) up to 2 years
Secondary Outcome
Measure Time Frame
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)
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-01-097 Day 15
Apparent Clearance (CL/F) of UCT-01-097 Cycle 1 (each cycle is 28 days)
Apparent Volume of Distribution (Vz/F) of UCT-01-097 Cycle 1 (each cycle is 28 days)
Accumulation Ratio (Rac) of UCT-01-097 Cycle 1 (each cycle is 28 days)
Terminal Half-life (t1/2) of UCT-01-097 Cycle 1 (each cycle is 28 days)
Objective Response Rate (ORR) up to 2 years
Time to Response (TTR) up to 2 years
Duration of Response (DOR) up to 2 years
Progression Free Survival (PFS) up to 2 years
1 Year Overall Survival (1YOS) 1 year
2 Year Overall Survival (2YOS) 2 years
Enrollment 106
Condition
Intervention

Intervention Type: Drug

Intervention Name: UCT-01-097

Description: Orally available kinase inhibitor

Intervention Type: Drug

Intervention Name: Gemcitabine

Description: Gemcitabine injection for intravenous use.

Arm Group Label: Dose Finding in Combination - Part 3

Other Name: Gemzar

Intervention Type: Drug

Intervention Name: Paclitaxel

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

Arm Group Label: Dose Finding in Combination - Part 3

Other Name: Abraxane

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stephen Letrent, PharmD, PhD Study Director 1200 Pharma, LLC
Overall Contact

Last Name: Stephen Letrent, PharmD, PhD

Phone: 858-342-6652

Email: [email protected]

Location
Facility: Contact: UCLA - JCCC Clinical Research Unit Zev Wainberg, MD 310-586-2094
Location Countries

United States

Verification Date

February 2021

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Dose Finding as Monotherapy - Part 1

Type: Experimental

Label: Expansion as Monotherapy - Part 2

Type: Experimental

Label: Dose Finding in Combination - Part 3

Type: Experimental

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov