Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADCT-402 · 1 trial · 9 indications
A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: * 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 (TLS). Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage. * CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia). * CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication). * CTCAE Grade 2 or higher skin ulceration.
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 participants 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.
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 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 |
|---|---|---|
| Part 1: ADCT-402 dose escalation | EXPERIMENTAL | In Part 1 (dose escalation) participants will receive intravenous (IV) infusions of ADCT-402 at escalating doses, according to a 3+3 study design. Doses will be escalated from 15 µg/kg to 200 µg/kg on Day 1 of each cycle, with cycle lengths of 3 or 6 weeks. |
| Part 2: ADCT-402 dose expansion | EXPERIMENTAL | In Part 2 (expansion), participants will be assigned to the recommended dose level(s) and schedule(s) of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee. Participants will receive intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W). |
| Name | Type | Description |
|---|---|---|
| ADCT-402 | DRUG | intravenous infusion |
Inclusion Criteria: * Male or female participants, ages 18 years or older with pathologically confirmed relapsed or refractory B-cell lineage NHL who have failed or are intolerant to established therapy, or for whom no other treatment options are available. * Refractory or relapsed B-cell NHL (per ...
ADCT-402 is an investigational small molecule being studied for the treatment of Non-Hodgkin Lymphoma, specifically relapsed or refractory B-cell lineage Non-Hodgkin Lymphoma. It is also being evaluated in related conditions including Burkitt's lymphoma, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia, and primary mediastinal B-cell lymphoma.
ADCT-402 is being developed by ADC Therapeutics SA, a biopharmaceutical company traded under the ticker ADCT. The company is conducting clinical research on this investigational agent for the treatment of Non-Hodgkin Lymphoma.
ADCT-402 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of ADCT-402 in patients with relapsed or refractory B-cell lineage Non-Hodgkin Lymphoma has been completed.
ADCT-402 has one completed clinical trial, identified as NCT02669017. This Phase 1 study enrolled 183 participants with relapsed or refractory B-cell lineage Non-Hodgkin Lymphoma and related B-cell malignancies. The trial was conducted in the United States, Italy, and the United Kingdom, and included patients aged 18 years and older.
No alternative names for ADCT-402 have been identified. The drug is known by its investigational code name ADCT-402 and is being developed by ADC Therapeutics SA for the treatment of Non-Hodgkin Lymphoma.