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

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04761601
• Other study ID #: UCT01097-001
• Status: Terminated
• Phase: Phase 1
• Start date: March 3, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: 1200 Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: February 29, 2024
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• UCT-01-097
Orally available kinase inhibitor
• Gemcitabine
Gemcitabine injection for intravenous use.
• Paclitaxel
Paclitaxel protein-bound particles for injectable suspension (albumin-bound).

Locations

Country	Name	City	State
United States	Winship Institute of Emory University	Atlanta	Georgia
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	UCLA - JCCC Clinical Research Unit	Los Angeles	California
United States	Sarah Cannon	Nashville	Tennessee
United States	Torrance Memorial	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
1200 Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Tolerated Dose (MTD)	Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants	28 Days
Primary	Recommended Phase 2 Dose (RP2D)	Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data	up to 2 years
Secondary	Maximum Plasma UCT-01-097 Concentration (Cmax)	PK assessment for UCT-01-097	Day 1
Secondary	Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss)	PK assessment for UCT-01-097	Day 15
Secondary	UCT-01-097 Trough Plasma Concentration (Cmin)	PK assessment for UCT-01-097	Day 1
Secondary	UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss)	PK assessment for UCT-01-097	Day 15
Secondary	Time of Maximum Plasma UCT-01-097 Concentration (Tmax)	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Secondary	Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-01-097	PK assessment for UCT-01-097	Day 15
Secondary	Apparent Clearance (CL/F) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Secondary	Apparent Volume of Distribution (Vz/F) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Secondary	Accumulation Ratio (Rac) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Secondary	Terminal Half-life (t1/2) of UCT-01-097	PK assessment for UCT-01-097	Cycle 1 (each cycle is 28 days)
Secondary	Objective Response Rate (ORR)	Percentage of participants with best response of CR or PR according to RECIST 1.1	up to 2 years
Secondary	Time to Response (TTR)	Time from start of treatment to complete response or partial response	up to 2 years
Secondary	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
Secondary	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
Secondary	1 Year Overall Survival (1YOS)	Proportion of participants alive at 1 year from the start of treatment to death from any cause	1 year
Secondary	2 Year Overall Survival (2YOS)	Proportion of participants alive at 2 years from the start of treatment to death from any cause	2 years