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ADCT-901 · 1 trial · 1 indication
Adverse events (AEs) and serious adverse events (SAEs) were defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of ADCT-901 as monotherapy. Participants can receive ADCT-901 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first. |
| Part 2: Dose Expansion | EXPERIMENTAL | In Part 2 (dose expansion), participants will receive ADCT-901 monotherapy at the dose identified as the RP2D/MTD in Part 1 (dose escalation). Participants will be split into two groups: Group 1: An indication for which ADCT-901 showed in Part 1 to have preliminary activity. Group 2: A group of participants with Part 1 indications, except for the one selected in Group 1 of Part 2. No more than 30% of participants with the same indication are allowed in this basket group. Participants can receive ADCT-901 until disease progression, AE, or other discontinuation criteria, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| ADCT-901 | DRUG | Intravenous infusion |
Inclusion Criteria: 1. Pathologic diagnosis of selected solid tumor malignancy that is locally advanced or metastatic at time of Screening: cholangiocarcinoma, ovarian/fallopian tube cancers, prostate cancer, renal cell carcinoma, and triple negative breast cancer (TNBC). Note: Histologic varia...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ADCT-901 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, and a completed trial evaluated its safety, tolerability, pharmacokinetics, and antitumor activity in participants with selected advanced solid tumors.
ADCT-901 is being developed by ADC Therapeutics SA, a biopharmaceutical company. The company's stock is traded under the ticker symbol ADCT.
ADCT-901 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical studies.
ADCT-901 has one completed clinical trial, identified as NCT04972981. This Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-901 in participants with selected advanced solid tumors, enrolling 30 participants in the United States, Spain, and the United Kingdom.
ADCT-901 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug has not yet received regulatory approval for any indication.