Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ADCT-301, Cami
Camidanlumab tesirine · 2 trials · 4 indications
ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.
A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants): * Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection * CTCAE Grade 4 neutropenia lasting \>7 days * CTCAE Grade 4 thrombocytopenia * CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion * CTCAE Grade 4 anemia A non-hematologic DLT is defined as: * CTCAE Grade 4 tumor lysis syndrome * CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia) * CTCAE Grade 3 or higher hypersensitivity reaction * CTCAE Grade 2 or higher skin ulceration * CTCAE Grade 2 or higher peripheral sensory or motor neuropathy
The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.
A treatment-emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
| Arm | Type | Description |
|---|---|---|
| Camidanlumab Tesirine | EXPERIMENTAL | Camidanlumab Tesirine is administered as a 30- minute intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks). Camidanlumab Tesirine will be administered at a dose of 45 μg/kg every 3 weeks for 2 cycles, then 30 μg/kg for subsequent cycles. |
| 3 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. |
| 5 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles. |
| 8 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. |
| 13 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles. |
| 20 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles. |
| 30 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. |
| 45 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles. |
| 60 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles. |
| 80 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles. |
| 100 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles. |
| 150 μg/kg | EXPERIMENTAL | Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles. |
| 300 μg/kg | EXPERIMENTAL | A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles). |
| Name | Type | Description |
|---|---|---|
| Camidanlumab Tesirine | DRUG | Intravenous Infusion |
Inclusion Criteria: 1. Written informed consent must be obtained prior to any procedures. 2. Male or female participant aged 18 years or older. (16 years or older at US based sites) 3. Pathologic diagnosis of classical Hodgkin lymphoma (cHL). 4. Patients with relapsed or refractory cHL, who have re...
Camidanlumab tesirine is being studied for relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma. It is an investigational antibody-drug conjugate developed by ADC Therapeutics SA. Clinical trials have enrolled patients with these lymphoma types who have received prior treatments.
Camidanlumab tesirine is an antibody-drug conjugate that targets CD25, a protein found on certain lymphoma cells. The antibody portion binds to CD25 and delivers a cytotoxic payload to the cancer cells. This targeted approach aims to kill malignant cells while limiting damage to normal tissues.
Camidanlumab tesirine is being developed by ADC Therapeutics SA, a biopharmaceutical company focused on antibody-drug conjugates. The company's ticker symbol is ADCT. ADC Therapeutics is responsible for the clinical development of this agent in lymphoma indications.
Camidanlumab tesirine is in clinical development. It has been evaluated in a Phase 1 trial and a Phase 2 trial, both of which are completed. The drug is investigational and has not been approved by the FDA for any indication.
Camidanlumab tesirine has been studied in two completed clinical trials: NCT02432235, a Phase 1 trial in relapsed or refractory Hodgkin and non-Hodgkin lymphoma, and NCT04052997, a Phase 2 trial in relapsed or refractory Hodgkin lymphoma. Both trials have finished enrolling and are completed.
Yes, camidanlumab tesirine is also known as ADCT-301. This alternative name is used in clinical trial identifiers and scientific literature. Both names refer to the same antibody-drug conjugate developed by ADC Therapeutics SA.