Clinical trial · Interventional
MLN0264 in Previously Treated Asian Participants With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C
A Phase 1/2 Trial of MLN0264 in Previously Treated Asian Patients With Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl Cyclase C (GCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated because preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian participants with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl Cyclase C (GCC).
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastrointestinal Carcinoma | — | UNRESOLVED | — |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Gastric Adenocarcinoma | Gastric Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | CURATED_BROADER | 0.78 |
| Recurrent Gastric Adenocarcinoma | Gastric Adenocarcinoma | CURATED_BROADER | 0.78 |
| Recurrent Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | CURATED_BROADER | 0.78 |
| Recurrent Gastrointestinal Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MLN0264 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MLN0264
- description
- Phase 1: MLN0264 1.2 milligram per kilogram (mg/kg) starting dose, Intravenous (IV), on Day 1 of 3 week cycles, for up to 1 year or until disease progression or unacceptable toxicity. Dosage of MLN0264 will be increased to 1.5 mg/kg then 1.8 mg/kg using a 3 + 3 dose escalation design to determine a maximum tolerated dose (MTD) and/or recommended Phase 2 Dose (RP2D). Phase 2: MLN0264, IV, on Day 1 of 3 week cycles, for up to 1 year or until disease progression or unacceptable toxicity. Dosage for this phase will be determined from results of Phase 1 MTD/RP2D.
- interventionNames
- Drug: MLN0264
Primary outcomes (37)
- measure
- Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
- timeFrame
- Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks)
- measure
- Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has Diagnosis of GI carcinoma with Immunohistochemistry/ Immunohistochemical (IHC) evidence of expression of GCC protein (H-score of 10 or greater), for which standard treatment is no longer effective or does not offer curative or life-prolonging potential. * Has completed prior chemotherapy, immunotherapy or radiation therapy at least 4 weeks prior to enrollment (except for Avastin \[bevacizumab\] for which at least 8 weeks from its last administration should elapse prior to enrollment). * Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the stomach or gastroesophageal junction with IHC evidence of expression of GCC indicated by an H-score of 10 or greater. * Has completed prior chemotherapy, immunotherapy or radiation therapy at least 4 weeks prior to enrollment. * Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. * Has Eastern Cooperative Oncology Group performance status of 0 or 1 (within 14 days prior to enrollment). * Females must be 1-year postmenopausal, or even if surgically sterile, agree to use other acceptable forms of birth control. * Has adequate organ and hematological function. * Has resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Exclusion Criteria: * Has Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent. * Female participants who are in the lactation period, even if they discontinue breastfeeding, or have a positive pregnancy test during the Screening period. * Has uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months prior to enrollment. * Has treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing Torsades de Pointes that cannot be discontinued or switched to a different medication prior to starting study drug. * Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically -significant, or repeated baseline prolongation of the rate-corrected QT interval millisecond (msec) of electrocardiograph (QTc). * Ongoing or clinically significant active infection. * Has signs of peripheral neuropathy. * Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment. * Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug. * Has any preexisting medical condition of sufficient severity to prevent full compliance with the study. * Has past or concurrent history of neoplasm other than GI carcinoma (phase 1) or gastric adenocarcinoma (phase 2), except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri. * Known diagnosis of human immunodeficiency virus (HIV) infection. * Has asymptomatic brain metastases. * Has an alcohol or substance abuse disorder. * Has positive test for hepatitis B surface antigen. * History of hypersensitivity to any ingredient of MLN0264.
References
Publications (0)
Data not yet available