FGFR Inhibitor ET0111 Monotherapy in Patients With Advanced Solid Tumors

NCT05522309 | Unknown Phase 1

• 1 other identifier: ET0111-101
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Determination of Maximum Tolerated Dose (MTD) of ET0111

  MTD based on Number of participants with dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as any toxicity not attributable to the disease or disease-related processes under investigation, which occurs before the end of Cycle 1 (21 days as a cycle)

  Approximately 2 years

• Recommended Phase 2 Dose (RP2D)

  RP2D may be the same dose level or lower than the determined MTD

  Approximately 2 years

• Number of participants with adverse events

  All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments

  Approximately 2 years

Secondary Outcomes (9)

• Area under the curve

  Approximately 2 years

• Cmax

  Approximately 2 years

• Tmax

  Approximately 2 years

• T1/2

  Approximately 2 years

• Objective response rate

  Approximately 2 years

Other Outcomes (3)

• blood phosphorus

  Approximately 2 years

• ET0111 metabolites identification

  Approximately 2 years

• NGS test of FGF/FGFR

  Approximately 2 years

Study Arms (1)

Dose Escalation and Dose Expansion

EXPERIMENTAL

ET0111 will be administered orally once daily in 21 days treatment cycles.

Drug: ET0111

Interventions

ET0111 DRUG

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).

Dose Escalation and Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
• Aged at least 18 years at the time of ICF signature.
• 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).
• Estimated life expectancy of minimum of 12 weeks.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
• 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.

You may not qualify if:

• 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..
• Have current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
• 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
• Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression.
• Prior therapy with any irreversible FGFR inhibitor.

Sponsors & Collaborators

• Etern BioPharma (Shanghai) Co., Ltd: lead

Study Sites (5)

Beijing Tongren Hospital,CMU

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang university school of medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Study Officials

• Jianming Xu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Luo

CONTACT

86 021 50186958; xin.luo@eternbio.com

Xiaoyan Li

CONTACT

+862150186958; Xiaoyan.li@eternbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: August 31, 2022
• Study Start: August 30, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)