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 |
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| 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. |
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| 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 |
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| Secondary Outcome |
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| 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 |
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| 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 |
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| Overall Official |
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| Overall Contact |
Last Name: Stephen Letrent, PharmD, PhD Phone: 858-342-6652 Email: [email protected] |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
February 2021 |
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| Responsible Party |
Type: Sponsor |
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| 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 |
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| Patient Data | No | ||||||||||||||||||||||||||||||||||
| Study Design Info |
Allocation: Non-Randomized Intervention Model: Sequential Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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