FGFR Inhibitor ET0111 Monotherapy in Patients With Advanced Solid Tumors

Trial Title: FGFR Inhibitor ET0111 Monotherapy in Patients With Advanced Solid Tumors

NCT ID: NCT05522309

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ET0111
Description: Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with ET0111 administered, once daily (QD).
Arm group label: Dose Escalation and Dose Expansion

Summary: This is a Phase I, open-label, multi-center, dose-finding study to assess the safety, pharmacokinetics, and preliminary efficacy of ET0111 in patients with advanced solid tumors. It is anticipated that approximately 37 subjects will be enrolled in the dose-escalation phase of the study. ET0111 will be administered orally once daily (QD) in 21-day treatment cycles.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. 2. Aged at least 18 years at the time of ICF signature. 3. Histological or cytological confirmation of a solid tumor and have progressed despite standard therapy(ies), or are intolerant to standard therapy (ies), or have a tumor for which no standard therapy(ies) exists. Locally recurrent disease must not be amenable to surgical resection or radiotherapy with curative intent (patients who are considered suitable for surgical or ablative techniques following down-staging with study treatment are not eligible). 4. Estimated life expectancy of minimum of 12 weeks. 5. Patient with solid tumors must have at least 1 lesion, not previously irradiated, that can be accurately measured at pre-dose as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with Computerised Tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature. 7. Males and Females of child-bearing potential must agree to use effective contraception from the time ICF signature until 12 weeks after the last dose. Females of childbearing potential include those who are premenopausal and those who are 2 years postmenopausal. Pregnancy tests for female of child-bearing potential must have a negative serum pregnancy test at Screening. Exclusion Criteria: 1. Have a history and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification.. 2. Have current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc. 3. As judged by the investigator, any evidence of significant ophthalmological abnormalities including but not limited to history or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO, retinal macular degeneration, uncontrolled glaucoma, cataract or marked decrease in visual acuity, symptomatic severe dry eye, conjunctivitis, or corneal ulcer. Prior bone marrow or organ transplantation 4. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression. 5. Prior therapy with any irreversible FGFR inhibitor.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Tongren Hospital,CMU

Address:
City: Beijing
Country: China

Status: Not yet recruiting

Contact:
Last name: Shurong Zhang

Facility:
Name: Chinese PLA General Hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Jianming Xu

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Country: China

Status: Not yet recruiting

Contact:
Last name: Yanqiao Zhang

Facility:
Name: Qilu Hospital of Shandong University

Address:
City: Jinan
Country: China

Status: Not yet recruiting

Contact:
Last name: Yufeng Cheng

Facility:
Name: The First Affiliated Hospital of Zhejiang university school of medicine

Address:
City: Hangzhou
Country: China

Status: Not yet recruiting

Contact:
Last name: Nong Xu

Start date: August 30, 2022

Completion date: May 1, 2025

Lead sponsor:
Agency: Etern BioPharma (Shanghai) Co., Ltd
Agency class: Industry

Source: Etern BioPharma (Shanghai) Co., Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05522309