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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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ADCT-901 is an investigational small molecule developed by ADC Therapeutics SA for the treatment of selected advanced solid tumors. It is designed to target KAAG1, a tumor-associated antigen. ADCT-901 has been studied in a Phase 1 clinical trial and is not approved for any indication.
ADCT-901 is being evaluated for use in patients with selected advanced solid tumors. The Phase 1 study enrolled adults aged 18 years and older with these cancers. It is an investigational therapy and has not been approved for commercial use in any indication.
ADCT-901 targets KAAG1, a tumor-associated antigen expressed in certain solid tumors. By binding to KAAG1, the agent is designed to deliver its therapeutic effect selectively to cancer cells. This targeted approach is intended to focus activity on tumor tissue while limiting effects on normal cells.
ADCT-901 is being developed by ADC Therapeutics SA, a clinical-stage oncology company that trades under the ticker ADCT. The company is the sponsor of the Phase 1 study evaluating ADCT-901 in advanced solid tumors. ADC Therapeutics focuses on antibody-drug conjugate and related targeted oncology therapies.
ADCT-901 is in Phase 1 clinical development. The single Phase 1 trial, NCT04972981, has been completed, and no active trials are currently listed. ADCT-901 is investigational and has not received FDA approval for any indication.
ADCT-901 has been studied in one Phase 1 trial, NCT04972981, titled a study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-901 in participants with selected advanced solid tumors. The trial enrolled 30 participants across the United States, Spain, and the United Kingdom and is now completed.