Status and phase
Conditions
Treatments
About
The primary objective of this study to evaluate the safety and tolerability of IBI334 and determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI334.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Male or female subjects ≥ 18 years old;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
Anticipated life expectancy of ≥ 12 weeks;
Adequate bone marrow and organ function;
Criteria for dose escalation phase only:
Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available (mainly focused on non-small-cell lung cancer, head and neck squamous cell carcinoma and RAS-wildtype colorectal cancer);
At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Criteria for dose expansion phase only:
Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
128 participants in 6 patient groups
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Central trial contact
Emilia Tan
Data sourced from clinicaltrials.gov
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