Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ami-LC-MD · 1 trial · 1 indication
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
Ami-LC-MD is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development for oncology indications.
Ami-LC-MD is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with advanced solid malignancies.
Ami-LC-MD is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and potential effectiveness in treating neoplasms.
Ami-LC-MD is being studied in a Phase 1 clinical trial registered as NCT04606381, titled "A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies." The trial is active but not recruiting participants, with an enrollment of 158 patients across the United States, Canada, South Korea, and the United Kingdom.
Ami-LC-MD is associated with the drug amivantamab, as indicated by the clinical trial title that references amivantamab subcutaneous administration. The trial NCT04606381 evaluates amivantamab given subcutaneously for advanced solid malignancies, and Ami-LC-MD appears to be a formulation or designation of this drug.