- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05327231
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
November 15, 2022 updated by: InxMed (Shanghai) Co., Ltd.
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
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Anyang, Henan, China
- Anyang Tumor Hospital
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Zhengzhou, Henan, China
- Henan Cancer Hospital
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Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University
-
-
Jiangsu
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Nanjing, Jiangsu, China
- The Affiliated Hospital of Nanjing University Medical School
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-
Liaoning
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Shenyang, Liaoning, China
- The First Hospital of China Medical University
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Shanghai
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Shanghai, Shanghai, China
- Shanghai East Hospital
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-
Shanxi
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Xi'an, Shanxi, China
- The First Affiliated Hospital of Xi 'an Jiaotong University
-
-
Tianjin
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Tianjin, Tianjin, China
- Tianjin Medical University Cancer Institute & Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
1.Has histologically or cytologically confirmed diagnosis of locally advanced and/or metastatic gastric or GEJ adenocarcinoma.
- For monotherapy, participants need to be failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable.
- For combination therapy, participants need to have disease progression within 3 months after at least first-line therapy.
- 2.Has at least one measurable tumor lesion per RECIST 1.1.
- 3.Has an ECOG performance status of 0 or 1.
- 4.Estimated life expectancy is more than 3 months.
- 5.Adequate organ and bone marrow functions.
- 6.Has been fully informed and provided written informed consent for the study
Exclusion Criteria:
- 1.Has other histological types other than adenocarcinoma.
2.For participants with HER2/neu positive tumors or have an unknown tumor status, need to match the following:
- If HER2/neu positive, participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
- Participants with unknown status must have their HER2/neu status determined locally. If HER2/neu-negative, the participant will be eligible. If HER2/neu-positive, the participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
- 3.Has had disease progression after docetaxel/paclitaxel containing treatment (combination therapy only).
- 4.Has received prior systemic therapies (i.e. chemotherapy, biotherapy, endocrinotherapy, and immunotherapy) within 4 weeks prior to start of study treatment.
- 5.Has received prior radiotherapy within 2 weeks prior to start of study treatment.
- 6.Has severe allergy or hypersensitivity to IN10018 and/or docetaxel, or any components used in their preparation or has contraindication for taxane therapy. For participants in monotherapy group, only restriction to IN10018 applies.
- 7.Has severe renal disease or impaired renal function.
- 8.Has an active infection requiring systemic therapy within 2 weeks prior to start of study treatment.
- 9.Has a history or current evidence of interstitial lung disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IN10018 Monotherapy
Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
|
IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
|
EXPERIMENTAL: IN10018 Combination with Docetaxel
Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
Docetaxel 75mg/m2 every 21 days a cycle.
|
IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
Docetaxel 75mg/m2 every 21 days a cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability in combination group
Time Frame: up to 24 months
|
Number of patients with adverse event in combination group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in combination group
|
up to 24 months
|
DLTs in combination group
Time Frame: 21 days
|
Number of patients with dose-limited toxicities (DLTs) in combination group
|
21 days
|
Phase II dose of IN10018 in combination with Docetaxel
Time Frame: up to 24 months
|
Determine the recommended phase II dose (RP2D) of IN10018 in combination with Docetaxel
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability in IN10018 monotherapy group
Time Frame: up to 24 months
|
Number of patients with adverse event in monotherapy group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in monotherapy group
|
up to 24 months
|
DLTs in IN10018 monotherapy group
Time Frame: up to 24 months
|
Number of patients with dose-limited toxicities (DLTs) in monotherapy group
|
up to 24 months
|
Objective response rate (ORR) per RECIST v1.1
Time Frame: up to 24 months
|
Defined as the proportion of patients with complete response (CR) or partial response (PR).
|
up to 24 months
|
Duration of objective response (DOR) per RECIST v1.1.
Time Frame: up to 24 months
|
Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first
|
up to 24 months
|
Disease Control Rate (DCR) per RECIST v1.1.
Time Frame: up to 24 months
|
Defined as the proportion of patients with CR, PR, or stable disease (SD)
|
up to 24 months
|
Progression-free survival (PFS) per RECIST v1.1.
Time Frame: up to 24 months
|
Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
|
up to 24 months
|
Overall survival (OS).
Time Frame: up to 30 months
|
Defined as the time from the start of any study treatment to the date of death due to any cause.
|
up to 30 months
|
Pharmacokinetics (PK):AUC
Time Frame: up to 24 months
|
Area under the concentration-time curve (AUC).
|
up to 24 months
|
Pharmacokinetics (PK):Cmax
Time Frame: up to 24 months
|
PK: Maximum concentration (Cmax).
|
up to 24 months
|
PK:Tmax
Time Frame: up to 24 months
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Time to Cmax (Tmax).
|
up to 24 months
|
PK:Ctrough
Time Frame: up to 24 months
|
Trough concentration (Ctrough).
|
up to 24 months
|
PK:t1/2
Time Frame: up to 24 months
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Elimination half-life (t1/2).
|
up to 24 months
|
PK:CL/F
Time Frame: up to 24 months
|
apparent clearance (CL/F).
|
up to 24 months
|
PK:Vd/F
Time Frame: up to 24 months
|
Apparent volume of distribution (Vd/F).
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 9, 2020
Primary Completion (ACTUAL)
December 3, 2021
Study Completion (ACTUAL)
March 31, 2022
Study Registration Dates
First Submitted
March 29, 2022
First Submitted That Met QC Criteria
April 6, 2022
First Posted (ACTUAL)
April 14, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 16, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IN10018-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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