| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04606381 | A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 158 | — | — | Nov 10, 2020 | Apr 1, 2027 | Jun 5, 2026 | 12 | United States, Canada +2 |
Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration.
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of participants with DLT will be assessed.
Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
| Arm | Type | Description |
|---|---|---|
| Part 1: Ami-LC-MD and Ami-LC | EXPERIMENTAL | Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC) SC infusion. |
| Part 2: Ami-HC and Ami-HC-CF | EXPERIMENTAL | Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF). |
| Name | Type | Description |
|---|---|---|
| Ami-LC-MD | DRUG | Participants will receive amivantamab admixed with rHuPH20 SC infusion. |
| Ami-LC | DRUG | Participants will receive amivantamab SC infusion. |
| Ami-HC | DRUG | Participants will receive amivantamab SC infusion. |
| Ami-HC-CF | DRUG | Participants will receive amivantamab co-formulated with rHuPH20 as SC injection. |
Inclusion criteria: * Part 1 and Part 2: Participant must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and which may derive benefit from epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transition tyrosine kinase receptor/hepatoc...