Clinical trial NCT04222842: CM082 in Patients With Myopic Choroidal Neovascularization (CNV)
Official title: Phase I Study of CM082 in Patients With Myopic Choroidal Neovascularization (CNV)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Myopic Choroidal Neovascularisation
Lead sponsor: AnewPharma
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With mCNV.

Detailed description: This is a multicenter, open-label, single-arm, phase I Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with mCNV. The study will be performed in two different parts, dose-escalation phase (Part 1) and dose-expansion phase (Part 2). Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles. There are three dose levels, 25mg BID,50mg QD and 50mg BID. The total treatment period is tentatively set at 3 cycles (12 weeks). Based on data from dose escalation studies, identify safe and effective doses for expanded enrollment studies.The assessment of the safety and efficacy will be done in 2、4、8、12weeks after the first dose.Also, single/multiple dose pharmacokinetics in these patients will be studied.

Eligibility criteria: Inclusion Criteria:

* diagnosis of active CNV secondary to pathologic myopia and the study eye must have the following lesion characteristics: (a)presence of high myopia with greater than -6 diopters of spherical equivalencef or anteroposterior elongation greater than 26 mm, (b) presence of at least 1 of the following lesion types: subfoveal; juxtafoveal; extrafoveal with involvement of the central macular area and margin of the optic disk with involvement of the central macular area, (c) vision loss due to the above causes, (d) ETDRS BCVA 24 to 78 letters.
* Patients with no previous anti-VEGF therapy.
* Adequate bone marrow, hepatic, and renal functions.
* Willing to sign the ICF and comply with the study protocol.

Exclusion Criteria:

* CNV due to causes other than mCNV.
* Any significant disease in the study eye that could compromise BCVA.
* Active eye infection in any eye.
* Previous treatment with photodynamic therapy (PDT), external beam radiation, laser photocoagulation, or transpupillary thermotherapy within

  1 month of the first dose.
* Intraocular surgery in the test eye within 3 months prior to the first dose.
* Any eye received intravitreal injection of corticosteroids within 3 months prior to first dose.
* Clinically significant, uncontrolled cardiovascular and cerebrovascular disease.
* Patients who had previously used strong inhibitors of CYP3A or strong inducers were discontinued from the first dose of CM082 \<5 drug half-lives (except for withdrawals longer than 14 days).
* Active hepatitis B (serum HBV DNA ≥ 500 IU / ml), hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive.
* Swallowing dysfunction, active gastrointestinal disease, or other diseases that affect the absorption, distribution, metabolism, and excretion of drugs.
* Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of the first dose.
* Allergy to the ingredients of the study drug.
* Patients who have fertility needs and who cannot use effective methods of contraception during the study period and at least 3 months after the end of treatment (except for male patients after birth control or female patients after birth control or postmenopausal).

Primary outcomes:
measure: Dose-Limiting Toxicity(DLT)
timeFrame: the first cycle(the first four weeks)
measure: Adverse event
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Best-Corrected Visual Acuity (BCVA)
timeFrame: 12 weeks
measure: Change in Choroidal Neovascularization (CNV) size
timeFrame: 12 weeks
measure: Change in Central Retinal Thickness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Youxin Chen
role: PRINCIPAL_INVESTIGATOR
References: