About this trial
Last updated a year ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 3 years ago
What is this trial about?
What are the Participation Requirements?
Key Inclusion Criteria:
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
- Measurable disease per RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
Additional Inclusion Criteria for Module 1:
• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut.,
NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity;
metastatic CRC.
Additional Inclusion Criteria for Module 2:
• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
Additional Inclusion Criteria for Module 3:
• Histologically or cytologically confirmed metastatic CRC.
Key Exclusion Criteria:
- History of (non-infectious) ILD/pneumonitis that required steroids, has current
ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging
at screening.
- Spinal cord compression or a history of leptomeningeal carcinomatosis.
- Active infection including tuberculosis and HBV, HCV or HIV
- Brain metastases unless treated (prior treatment required only for Module 1),
asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10
mg prednisone/day or equivalent for at least 4 weeks prior to start of study
treatment.
- Participants with cardiac comorbidities as defined in the study protocol