Spots Global Cancer Trial Database for IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
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Trial Identification
Brief Title: IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
Official Title: A Phase I, Open-label Clinical Trial to Evaluate Safety, Tolerability, Antitumor Activities and Pharmacokinetics of IN10018 as Mono or Combination Therapy in Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study ID: NCT05327231
Conditions
Study Description
Brief Summary: This is a phase I, multi-center clinical trial to evaluate the safety, tolerability, antitumor activities and pharmacokinetics of IN10018 as monotherapy or in combination with docetaxel in previously-treated locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Detailed Description: Eligibility patients will be enrolled into the study and assigned to treatment groups: 1) IN10018 monotherapy group, and 2) IN10018+Docetaxel combination group. This study contains 2 parts of dose escalation and dose expansion for each treatment group. The monotherapy group will enroll patients failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable, and explore IN10018 monotherapy RP2D with the starting dose of IN10018 100mg QD per 3+3 design. The combination group will enroll patients who have disease progression within 3 months after at least first-line therapy, and explore IN10018+docetaxel RP2D with the starting dose of IN10018 100mg QD + docetaxel 75mg/m2 per 3+3 design. The dose expansion part will start after attaining the RP2D of IN10018 monotherapy and IN10018+docetaxel combination therapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anyang Tumor Hospital, Anyang, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Shanghai East Hospital, Shanghai, Shanghai, China
The First Affiliated Hospital of XI 'AN Jiaotong University, Xi'an, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Contact Details
Name: Jin Li, Doctor
Affiliation: Shanghai East Hospital
Role: PRINCIPAL_INVESTIGATOR
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