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

• ClinicalTrials.gov Identifier: NCT04761601
• Recruitment Status: Recruiting
• First Posted: February 21, 2021
• Last Update Posted: September 9, 2022
• Sponsor: 1200 Pharma, LLC
• Information provided by (Responsible Party): 1200 Pharma, LLC

Tracking Information

• First Submitted Date: February 16, 2021
• First Posted Date: February 21, 2021
• Last Update Posted Date: September 9, 2022
• Actual Study Start Date: March 3, 2021
• Estimated Primary Completion Date: September 23, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2021)

• Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]
  Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
• Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
  Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
• Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 2 years ]
  Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 16, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
• Official Title: A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumor

Intervention

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

Study Arms

• Experimental: Dose Finding as Monotherapy - Part 1
  Intervention: Drug: UCT-01-097
• Experimental: Expansion as Monotherapy - Part 2
  Intervention: Drug: UCT-01-097
• Experimental: Dose Finding in Combination - Part 3
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 16, 2021): 106
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2024
• Estimated Primary Completion Date: September 23, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Stephen Letrent, PharmD, PhD; 858-342-6652; stephen.letrent@1200pharma.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04761601
• Other Study ID Numbers: UCT01097-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: 1200 Pharma, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: 1200 Pharma, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: 1200 Pharma, LLC
• Verification Date: September 2022