(Updated December 2021)
ACCRF has compiled a list of clinical trials for ACC patients with progressive disease to consider. This website is updated periodically, but may not list all the pertinent and available trials. Patients may search on their own for recruiting ACC clinical trials on the ClinicalTrials.gov website.
The clinical trials are broken down into three categories.
- The first table lists studies that are recruiting any and all ACC patients (usually phase II clinical trials).
- The second table lists studies appropriate for ACC patients whose tumors have been profiled and found to have activating alterations in NOTCH genes (either phase I or II clinical trials).
- The third table includes clinical trials for patients with unresectable (inoperable) or residual tumors. These typically incorporate radiation therapy.
In all cases, patients should consult with their physicians to discuss the appropriate course of action.
Not all clinical trials have similarly strong scientific rationales for why the drugs should be effective in ACC. The most promising studies will involve drugs that (1) target the known mechanisms of action that drive ACC progression, (2) demonstrate activity in preclinical models of ACC, and (3) have reports of clinical benefit in an ACC patient from a case study or Phase I clinical trial. To assist patients in appraising each clinical trial, we indicate whether the evidence supporting the scientific rationale is strong, solid or fair. This assessment is based on the underlying scientific rationale, and does not mean that a particular trial is better or worse for any given patient, and should be considered along with his or her physician.
The table below lists clinical trials that currently are recruiting ACC patients in particular or salivary gland cancer patients. Unless otherwise noted, these studies are for only ACC patients with recurrent or metastatic disease. Links are provided to descriptions of the drugs as well as the www.ClinicalTrials.gov summary of each study.
| Compound | Targets | Sponsor | Locations | Scientific Rationale | Info Link | Contact |
|---|---|---|---|---|---|---|
| SGN-B7H4V ADC (biopsies required at baseline and on-treatment) | B7H4 | Seagen | Houston, TX, USA | Strong | View | Renata Ferrarotto, MD [email protected] |
| CAB-AXL-ADC BA3011 (pre-treatment biopsy required to test for AXL expression) | AXL | BioAtla | USA, Hong Kong, Taiwan | Strong | View | Hazel Buncab 858-263-1598 [email protected] Ji Hwan Lee 858-286-7702 [email protected] |
| APG-115 | MDM2 | University of Michigan | Ann Arbor, MI, USA | Strong | View | Paul L Swiecicki, MD 1-734-647-1017 [email protected] Ryan Drzewicki [email protected] |
| ATRA Combinations | MYB | Shanghai Ninth People's Hospital | Shanghai, China | Strong | View | Guopei Zhu, MD 021-23271699 ext 5665 [email protected] |
| KB-0742 | CDK9 | Kronos | Boston, MA, USA Duarte, CA, USA San Antonio, TX, USA |
Solid | View | Director of Clinical Operations 650-484-1583 [email protected] |
| Lutetium-177-PSMA / Radioligand Therapy | PSMA | Peking Union Medical College Hospital | Beijing, China | Solid | View | Zhaohui Zhu, MD 86-13611093752 [email protected] |
| Stereotactic Body Radiation Therapy (for patients with up to 5 metastases) | Oligometastases | Dana Farber | Boston, MA, USA | Solid | View | Jonathan D Schoenfeld, MD, MPH 617-632-5296 [email protected] Glenn J Hanna, MD 617-632-3090 [email protected] |
| Sacituzumab Govitecan (Trodelvy) | TROP2 | Gilead | Houston, TX, USA | Solid | View | Renata Ferrarotto, MD [email protected] |
| LCB84 and anti-PD-1 monoclonal antibody (pre- and on-treatment biopsies required if deemed medically feasible and safe) | TROP2 | LegoChem Biosciences, Inc | Boston, MA Dallas, TX Houson, TX |
Solid | View | Glenn J Hanna, MD 617-632-3090 [email protected] Douglas Orr, MD 972-566-3000 [email protected] Anjali Raina 713-792-3238 [email protected] |
| Elraglusib and Pembrolizumab | GSK3beta | Actuate Therapeutics | Boston, MA, USA | Fair | View | Glenn J Hanna, MD 617-632-3090 [email protected] |
| Pembrolizumab and Docetaxel | PD-1 Immunotherapy | University of Chicago | Chicago, IL, USA | Fair | View | Alexander Pearson, MD, PhD [email protected] |
| Pembrolizumab and Pemetrexed | PD-1 Immunotherapy | Mayo Clinic | Rochester, MN, USA Scottsdale, AZ, USA |
Fair | View | Clinical Trials Referral Office 855-776-0015 [email protected] |
| Amivantamab | EGFR, MET | U of Cincinnati | Cincinnati, OH, Boston, MA, USA | Fair | View | Christine Vollmer 513-213-3203 Glenn J Hanna, MD 617-632-3090 |
| EGFR Tyrosine Kinase Inhibitors | EGFR | Qingdao Central Hospital | Qingdao, Shandong, China | Fair | View | Youxin Ji, MD 68665078 [email protected] |
| Implantable Microdevice for Drug Screening (not a therapy; research study for only surgical patients without prior drug treatment) | Various | DFCI (USA) | Boston, MA, USA | Not Applicable | View | Glenn J Hanna, MD 617-632-3090 [email protected] |
Approximately 25% of metastatic ACC patients have tumors with activating alterations in the NOTCH pathway (primarily in the NOTCH1 gene). These tumors behave more aggressively. Patients for whom tumor profiling has identified a NOTCH pathway alteration may wish to discuss the following studies with their physicians:
| Compound | Targets | Sponsor | Locations | Scientific Rationale | Info Link | Contact |
|---|---|---|---|---|---|---|
| CB-103 and Lenvatinib | NOTCH, VEGFR | Cellestia | Boston, MA, USA | Strong | View | Glenn J Hanna, MD 617-632-3090 [email protected] |
| AL101 (only for patients preceding surgery) | NOTCH | Ayala Pharmaceuticals | Houston, TX, USA | Strong | View | Renata Ferrarotto, MD 713-792-6363 [email protected] |
Historically, clinical trials involved only one or two treatments. Some newer trials are incorporating tumor profiling to direct patients to many more potential treatments within the same study. These “basket trials” try to match targeted drugs to genomic alterations in each patient’s particular tumor. Some of these trials profile the patient’s tumor as party of the study (NCI-MATCH) while others will suggest treatment decisions based on existing tumor profiling reports (ASCO TAPUR). The clinical trials listed below are not specifically for ACC patients, but may be worth considering in consultation with a knowledgeable physician.
| Compound | Modality | Sponsor | Locations | Info Link | Contact |
|---|---|---|---|---|---|
| Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy) (SANTAL) (for residual or unresectable tumors) | Radiation and Systemic Therapy | GORTEC | Saint-Mandé, France | View | François Régis FERRAND, MD +33 1 43 98 50 78 [email protected] Juliette THARIAT, Prof +33 06 45 53 98 01 [email protected] |
| Apatinib and Proton Radiation (for inoperable or residual ACC) | Radiation and Systemic Therapy | Shanghai Proton and Heavy Ion Center | Shanghai, China | View | Lin Kong, MD [email protected] Jiyi Hu, MD [email protected] |
| Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy | Radiation | Massachusetts General Hospital | Boston, MA, USA | View | Annie W Chan, MD 617-724-1159 [email protected] |
| Carbon Ion Only Irradiation vs Boost (ACCO) | Radiation | Heidelberg University | Heidelberg, Germany | View | Klaus Herfarth, Prof. Dr. +49 6221 568201 [email protected] |
| Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors (ETOILE) | Radiation | Hospices Civils de Lyon | Multiple sites in France | View | Pascal Pommier, MD (0)4 78 78 51 66 ext +33 [email protected] |
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