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

1200 Pharma

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Gemcitabine; Drug: Paclitaxel; Drug: UCT-01-097

Study type: Interventional

Funder types: Industry

Identifiers

NCT04761601

UCT01097-001

Details and patient eligibility

About

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 in patients with advanced solid tumors.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Dose Finding as Monotherapy - Part 1

Experimental group

Treatment:

Drug: UCT-01-097

Expansion as Monotherapy - Part 2

Experimental group

Treatment:

Drug: UCT-01-097

Dose Finding in Combination - Part 3

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Gemcitabine

Drug: UCT-01-097