IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma

NCT05327231 | Completed Phase 1

• 1 other identifier: IN10018-003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability in combination group

  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

  Number of patients with dose-limited toxicities (DLTs) in combination group

  21 days

• Phase II dose of IN10018 in combination with Docetaxel

  Determine the recommended phase II dose (RP2D) of IN10018 in combination with Docetaxel

  up to 24 months

Secondary Outcomes (14)

• Safety and tolerability in IN10018 monotherapy group

  up to 24 months

• DLTs in IN10018 monotherapy group

  up to 24 months

• Objective response rate (ORR) per RECIST v1.1

  up to 24 months

• Duration of objective response (DOR) per RECIST v1.1.

  up to 24 months

• Disease Control Rate (DCR) per RECIST v1.1.

  up to 24 months

Study Arms (2)

IN10018 Monotherapy

EXPERIMENTAL

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.

Drug: IN10018

IN10018 Combination with Docetaxel

EXPERIMENTAL

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.

Drug: IN10018; Drug: Docetaxel

Interventions

IN10018 DRUG

IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.

IN10018 Combination with Docetaxel; IN10018 Monotherapy

Docetaxel DRUG

Docetaxel 75mg/m2 every 21 days a cycle.

IN10018 Combination with Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Has at least one measurable tumor lesion per RECIST 1.1.
• Has an ECOG performance status of 0 or 1.
• Estimated life expectancy is more than 3 months.
• Adequate organ and bone marrow functions.
• Has been fully informed and provided written informed consent for the study

You may not qualify if:

• Has other histological types other than adenocarcinoma.
• 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.
• Has had disease progression after docetaxel/paclitaxel containing treatment (combination therapy only).
• Has received prior systemic therapies (i.e. chemotherapy, biotherapy, endocrinotherapy, and immunotherapy) within 4 weeks prior to start of study treatment.
• Has received prior radiotherapy within 2 weeks prior to start of study treatment.
• 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.
• Has severe renal disease or impaired renal function.
• Has an active infection requiring systemic therapy within 2 weeks prior to start of study treatment.
• Has a history or current evidence of interstitial lung disease.

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

Study Sites (8)

Anyang Tumor Hospital

Anyang, Henan, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital of XI 'AN Jiaotong University

Xi’an, Shanxi, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jin Li, Doctor

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 14, 2022
• Study Start: July 9, 2020
• Primary Completion: December 3, 2021
• Study Completion: March 31, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-09

Locations

CN (8)