A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2… (NCT02795988) | Clinical Trial Compass
CompletedPhase 1/2
A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer
Georgia, India64 participantsStarted 2017-08-30
Plain-language summary
The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The RP2D will be evaluated in the dose expansion Phase 2 study. The Phase 2 study is a randomized, open label comparison of IMU-131 plus standard of care chemotherapy versus standard of care chemotherapy alone.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Patient has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines;
✓. Age ≥ 20 years old;
✓. Life expectancy of at least 12 weeks;
✓. Phase 1b: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 6 months prior to Day 0; Phase 2: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 3 months prior to Day 0;
✓. Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to surgical resection;
✓. HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization \[FISH\] or chromogenic in situ hybridization \[CISH\]). Patients with IHC 2+ expression without confirmation of overexpression by fluorescent in situ hybridization \[FISH\] or chromogenic in situ hybridization \[CISH\]) may be included in Phase 1b with agreement of Imugene Limited;
✓. Phase 1b: ECOG performance status 0-1; Phase 2: ECOG performance status 0-2;
✓. At least one measurable lesion as defined by RECIST 1.1 criteria. Patients with non-measurable lesions may be included in Phase1b with agreement of Imugene Limited;
Exclusion criteria
✕. Previous treatment with trastuzumab or any other HER2/neu targeting antibody or agent;
✕. Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease;
What they're measuring
1
Phase 1b: Number of Participants With Adverse Events (AEs)
Timeframe: Up to approximately 7 months
2
Phase 2: Overall Survival (OS)
Timeframe: Up to approximately 30 months
3
Phase 2 Extension: Number of Participants With AEs
Timeframe: From date of first dose to date of last dose plus 30 days (Up to 24 months)
✕. Phase 1b: Patient not considered a candidate for 5-FU, capecitabine, or cisplatin chemotherapy; Phase 2: Patient not considered a candidate for 5-FU, capecitabine, cisplatin or oxaliplatin chemotherapy;
✕. History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; high risk uncontrolled arrhythmias; or New York Heart Association (NYHA) class II heart disease;
✕. If on warfarin (Coumadin®) or other vitamin K antagonists;
✕. Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
✕. Peripheral neuropathy or hearing loss of NCI CTCAE Grade \> 2;