⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors

Official Title: A Phase I, Single Arm, Multiple Dose, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KN035 Administered in Subcutaneous Injection as a Single Agent to Subjects With Advanced Solid Tumors

Study ID: NCT03101488

Conditions

Solid Tumors

Interventions

KN035

Study Description

Brief Summary: This dose escalation and dose expansion study is to evaluate and characterize the tolerability and safety profile of single agent KN035 in Chinese adult subjects with unresectable advanced carcinoma.

Detailed Description: Dose escalation study is to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor. Six dose levels are planned and include: 0.1, 0.3, 1.0, 2.5, 5, 10 mg/kg/dose. Subjects will be assigned to a dose level in the order of study entry. The first cohort of 1 subject will receive KN035 at 0.1 mg/kg/dose as a subcutaneous (sc) injection every week for a total of 4 injections (Days 1, 8, 15 and 22) in the first 28-day cycle. For the first 2 cohorts (0.1 and 0.3 mg/kg/dose), only one subject will be enrolled in each cohort until 1 subject experiences a ≥ Grade 2 drug-related adverse event in the first cycle, then 2 additional subjects will be enrolled at this cohort. Thereafter, the study will become the traditional 3+3 design with 3 or 6 subjects treated at this dose level and all subsequent dose levels depending upon the incidence of DLTs. However, if no ≥ Grade 2 drug-related adverse event occurs in the first 2 cohorts, starting with cohort 3, the study will become the traditional 3+3 design with 3 or 6 subjects enrolled. Dose expansion-1 study is planned to conduct in advanced hepatocellular cancer subjects at 2.5 mg/kg and 5 mg/kg dose level, respectively. Dose expansion-2 study is planned to conduct in advanced solid tumor subjects at 2.5 mg/kg and 5 mg/kg dose level, respectively

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hunan Cancer Hospital, Changsha, Hunan, China

First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Zhongshan Hospital affiliated to Fudan University, Shanghai, Shanghai, China

Affiliated Hospital of Military academy of medical sciences, Beijing, , China

Contact Details

Name: jianming xu

Affiliation: Affiliated Hospital of Military academy of medical sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: