A Phase 2 interventional study of Zalutumumab in Head and Neck Cancer and Squamous Cell Cancer, sponsored by Genmab. Completed at 48 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Genmab · Phase 2, Interventional, and Other
Among 1,314 studies in Head and Neck Neoplasms with a site in United States — 186 open to participants now, 283 under way, 14 of them phase 3. Head and Neck Neoplasms · United States.
Among the 1,314 studies in Head and Neck Neoplasms with a site in United States, this one is the 250th largest by enrollment of the 1,071 interventional ones that give a count, is one of 43 that started in 2008, is one of 353 in phase 2, and was the 305th registered.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 90 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →186 of the 1,314 studies in Head and Neck Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,314 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 43 started in 2008.
Median enrollment 36 across the 1,071 interventional studies, 80 across the 183 observational. Of the 941 that completed or were terminated, 346 (37%) have results posted.
333 of 1,314 have an industry lead sponsor. The 10 most frequent:
Genmab is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 13 (57%) have results posted.
Genmab has 7 studies filed under Head and Neck Neoplasms — fewer than ten, so there is no comparison to draw.
103 of the studies in Head and Neck Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05273307Phase 3University of California, San FranciscoAddressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy | 2026-11-30 |
| NCT06998069Phase 3Brown UniversityHead and Neck Cancer Study Project in the Geriatric Population | 2026-12-01 |
| NCT01266044Phase 3M.D. Anderson Cancer CenterControlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia | 2026-12-31 |
| NCT06915727Phase 3Mayo ClinicAn Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors | 2027-05-01 |
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
Among the 1,314 studies in Head and Neck Neoplasms with a site in United States, from their registry updates:
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Drug: Zalutumumab
Individual dose titration weekly i.v. doses
Overall Survival (OS)
OS was defined as time from start of treatment until date of death of any cause.
Time frame: From randomization until death, assessed up to 21 months
Objective Tumour Response
Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months.
Duration of Response
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months
Progression Free Survival (PFS)
PFS is defined as the time from start of treatment until disease progression or death.
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months
| Milestone | Zalutumumab 4-16 mg/kg |
|---|---|
| Started | 90 |
| Completed | 90 |
| Not completed | 0 |
OS was defined as time from start of treatment until date of death of any cause.
| months | Zalutumumab 4-16 mg/kg |
|---|---|
| Overall Survival (OS) | 5.3 (4.1 to 7.1) |
Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
| participants | Zalutumumab 4-16 mg/kg |
|---|---|
| Complete response | 1 |
| Partial response | 4 |
| Stable response | 30 |
| Progressive disease | 33 |
| Not evaluable | 20 |
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
| days | Zalutumumab 4-16 mg/kg |
|---|---|
| Duration of Response | NA (NA to NA) |
PFS is defined as the time from start of treatment until disease progression or death.
| months | Zalutumumab 4-16 mg/kg |
|---|---|
| Progression Free Survival (PFS) | 8.6 (8.0 to 10.4) |
Collected over From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zalutumumab 4-16 mg/kg | — | 83/90 (92.2%) | 90/90 (100%) |
| Event | Zalutumumab 4-16 mg/kg |
|---|---|
| DISEASE PROGRESSIONGeneral disorders | 55/90 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 9/90 |
| PNEUMONIAInfections and infestations | 7/90 |
| TUMOUR HAEMORRHAGENeoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/90 |
| DYSPHAGIAGastrointestinal disorders | 5/90 |
| HYPOKALAEMIAMetabolism and nutrition disorders | 4/90 |
| HYPOMAGNESAEMIAMetabolism and nutrition disorders | 4/90 |
| ANAEMIABlood and lymphatic system disorders | 3/90 |
| PNEUMONIA ASPIRATIONRespiratory, thoracic and mediastinal disorders | 3/90 |
| GENERAL PHYSICAL HEALTH DETERIORATIONGeneral disorders | 2/90 |
| Event | Zalutumumab 4-16 mg/kg |
|---|---|
| RASHSkin and subcutaneous tissue disorders | 68/90 |
| FATIGUEGeneral disorders | 19/90 |
| PYREXIAGeneral disorders | 18/90 |
| HYPOMAGNESAEMIAMetabolism and nutrition disorders | 18/90 |
| ASTHENIAGeneral disorders | 17/90 |
| NAUSEAGastrointestinal disorders | 16/90 |
| HEADACHENervous system disorders | 16/90 |
| VOMITINGGastrointestinal disorders | 15/90 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 14/90 |
| SKIN FISSURESSkin and subcutaneous tissue disorders | 13/90 |
All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
| Age, Categorical(Participants) | Zalutumumab 4-16 mg/kg |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 70 |
| >=65 years | 20 |
| Age, Continuous(years) | Zalutumumab 4-16 mg/kg |
|---|---|
| Mean | 59.1 ± 8.7 |
| Sex: Female, Male(Participants) | Zalutumumab 4-16 mg/kg |
|---|---|
| Female | 18 |
| Male | 72 |
| Region of Enrollment(participants) | Zalutumumab 4-16 mg/kg |
|---|---|
| Portugal | 10 |
| United States | 22 |
| Czech Republic | 6 |
| Slovakia | 4 |
| Peru | 4 |
| Austria | 3 |
| Israel | 12 |
| Chile | 8 |
| Germany | 11 |
| Colombia | 1 |
| Italy | 9 |
The record gives a start of Jan 2008, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 3 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zalutumumab