A Phase 1, First in Human, Dose-Escalation 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
NCT #
NCT04761601
Condition(s)
Pancreatic, Solid Tumor
Molecular Target(s)
ERK1/2
Drug Classification(s)
Small Molecule, Targeted Therapy
Agents(s)
UCT-01-097
Phase(s)
I
Mechanism of Action
UCT-01-097 may target, bind to and inhibit the activity of one or more kinases that play a key role in tumor cell proliferation.
Purpose
- How much of the study drug can be given alone with an acceptable level of side effects and in combination with Gemcitabine and Nab-paclitaxel
- The effects of the study drug (good and bad) and when given alone an in combination and in combination with Gemcitabine and Nab-paclitaxel
- How much of the study drug is absorbed into the blood and how fast it is removed when given alone an in combination and in combination with Gemcitabine and Nab-paclitaxel
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
- 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
Received prior treatment with ERK inhibitor(s)
Location
MCD
Similar Trials
Discover more trials like this.
Trial Number
Mechanism of Action
Drug Classifications
Target Required
Conditions
Site
TSC-007
n/a
n/a
Inactivating Alterations in TSC1 or TSC2
Solid Tumor
MCD
MCLA-128-CL01
Zenocutuzumab, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3
n/a
NRG1 fusion
Non-Small Cell Lung, Pancreatic
MCD
ENV-ONC-101
ENV- 101, a potent Hedgehog (Hh) pathway inhibitor
n/a
PTCH1 loss of function
Solid Tumor
MCD
Connect With Us
Whether you want to give a spark of hope or you are looking for it, we are here to help. If you have any questions or concerns, please contact us here.