Drugs / ADCT-301
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | Hodgkins lymphoma | 2020-07-06 | “U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the pivotal Phase 2 clinical trial of camidanlumab tesirine” adctherapeutics.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03621982 | Nov 2018 → Dec 2022 | colorectal cancer, esophageal cancer, fallopian tube cancer, gastric cancer +8 | ADC Therapeutics S.A. | Terminated | No outcome recorded |
| Phase 1 | NCT02588092 | Feb 2016 → Aug 2018 | acute lymphoblastic leukemia, acute myeloid leukemia | ADC Therapeutics S.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02432235 | Oct 2015 → Oct 2019 | Hodgkins lymphoma, non-Hodgkin lymphoma | ADC Therapeutics S.A. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04639024 | Dec 2021 → Nov 2022 | acute myeloid leukemia, myelodysplastic syndrome | Gwynn Long, M.D. | Terminated | No outcome recorded |
| Phase 2 | NCT04052997 | Sep 2019 → Jan 2023 | Hodgkins lymphoma | ADC Therapeutics S.A. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2022-11-08 | ADC Therapeutics S.A. | Results ADC Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Updates adctherapeutics.com ↗
The Phase 1b study of Cami in combination with pembrolizumab in solid tumors showed signals of immunomodulatory activity. |
| 2022-06-10 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Results from Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) in Relapsed or Refractory Hodgkin Lymphoma adctherapeutics.com ↗
The safety profile of Cami was substantially consistent with previously reported interim findings. |
| 2021-06-22 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Encouraging Interim Results from Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) Presented at the 16th Annual International Conference on Malignant Lymphoma adctherapeutics.com ↗ |
| 2021-05-26 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Online Publication of Camidanlumab Tesirine Phase 1 Results in The Lancet Haematology adctherapeutics.com ↗
The Phase 1 study demonstrates encouraging potential for Cami to provide a new treatment option for patients with relapsed or refractory Hodgkin lymphoma. |
| 2020-12-07 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Updated Clinical Data on Lead Antibody Drug Conjugate Programs Loncastuximab Tesirine (Lonca) and Camidanlumab Tesirine (Cami) Presented at 62nd American Society of Hematology Annual Meeting adctherapeutics.com ↗
Preliminary pivotal Cami data demonstrate 83% overall response rate and no new safety signals in patients with relapsed or refractory Hodgkin lymphoma |
| 2020-09-17 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Presentation of Preliminary Findings from Phase 1b Clinical Trial of Camidanlumab Tesirine (Cami) in Advanced Solid Tumors at ESMO Virtual Congress 2020 adctherapeutics.com ↗
Preliminary pharmacokinetic and biomarker data support continued evaluation of Cami as a novel immuno-oncology approach for patients with solid tumor cancers |
| 2020-09-10 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Publication Highlighting the Potential of Camidanlumab Tesirine (Cami) as a Novel Immuno-oncology Approach for Solid Tumor Cancers adctherapeutics.com ↗
Data demonstrated that single low doses of the CD25-targeted ADC resulted in potent and durable antitumor activity against established CD25-negative solid tumors with infiltrating Tregs, both as a monotherapy and in combination with an anti-PD1 checkpoint inhibitor. |
| 2020-07-06 | ADC Therapeutics S.A. | Regulatory ADC Therapeutics Announces U.S. Food and Drug Administration Has Lifted Partial Clinical Hold on Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine adctherapeutics.com ↗
ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL). |
All press releases naming this drug 11 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADCT-301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03621982 ↗ |
| Known as | Camidanlumab Tesirine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04052997 ↗ |
| Modality | Monoclonal antibody | “Camidanlumab tesirine is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead” NCT02432235 ↗ |
| Route | Intravenous | “Camidanlumab tesirine was administered intravenously (3-150 μg/kg) once every 3 weeks.” PMID 34048682 ↗ Jun 2021 |
| Target | IL2RA | “We aimed to evaluate camidanlumab tesirine, an anti-CD25 antibody-drug conjugate, in this patient population.” PMID 34048682 ↗ Jun 2021 |