Clinical trial · Interventional
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| IN10018 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IN10018 Monotherapy
- description
- 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.
- interventionNames
- Drug: IN10018
- type
- EXPERIMENTAL
- label
- IN10018 Combination with Docetaxel
- description
- 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.
- interventionNames
- Drug: IN10018
- Drug: Docetaxel
Primary outcomes (3)
- measure
- Safety and tolerability in combination group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available