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Monoclonal Antibodies

NKTR-255 for Squamous Cell Carcinoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Nektar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an expected average of 1 year
Awards & highlights

Study Summary

This trial is testing a new cancer drug, NKTR-255, as a possible treatment for patients with head and neck, colorectal, anal, or cervical cancer.

Eligible Conditions
  • Squamous Cell Carcinoma
  • Cervical Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Anal Carcinoma
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an expected average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an expected average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in combination with Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 monotherapy and in combination with Cetuximab in R/R HNSCC, CRC, cSCC, ASCC, and cervical cancer for Phase 2 Dose Expansion
Objective Response Rate (ORR) by RECIST 1.1 of NKTR-255 in combination with Cetuximab in R/R metastatic HNSCC or CRC for Phase 2 Dose Expansion
+1 more
Secondary outcome measures
Area under the concentration-time curve (AUC) for NKTR-255 and cetuximab
Change from baseline in immune cell populations (natural killer NK], CD8+ cells, and other immune populations) after administration of NKTR-255 in combination with cetuximab and NKTR-255 monotherapy
Change in cytokine levels after administration of NKTR-255 in combination with cetuximab and NKTR-255 monotherapy
+10 more

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Non-cardiac chest pain
18%
Alkaline phosphatase increased
18%
Aspartate aminotransferase increased
18%
Insomnia
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Dizziness
10%
Arthralgia
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Tracheostomy site bleeding
3%
Vertigo
3%
Alopecia
3%
Oral pain
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Expansion of NKTR-255 with Cetuximab - Cohort EExperimental Treatment2 Interventions
The RP2D of NKTR-255 will be evaluated as monotherapy and in combination with cetuximab in patients with cervical cancer.
Group II: Dose Expansion of NKTR-255 with Cetuximab - Cohort DExperimental Treatment2 Interventions
The RP2D of NKTR-255 will be evaluated as monotherapy and in combination with cetuximab in patients with ASCC.
Group III: Dose Expansion of NKTR-255 with Cetuximab - Cohort CExperimental Treatment2 Interventions
The RP2D of NKTR-255 will be evaluated as monotherapy and in combination with cetuximab in patients with cSCC.
Group IV: Dose Expansion of NKTR-255 with Cetuximab - Cohort BExperimental Treatment2 Interventions
The RP2D of NKTR-255 will be evaluated as monotherapy and in combination with cetuximab in patients with CRC.
Group V: Dose Expansion of NKTR-255 with Cetuximab - Cohort AExperimental Treatment2 Interventions
The RP2D of NKTR-255 will be evaluated as monotherapy and in combination with cetuximab in patients with HNSCC.
Group VI: Dose Escalation of NKTR-255 with CetuximabExperimental Treatment2 Interventions
Establish RP2D, of NKTR-255 with cetuximab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NKTR-255
2020
Completed Phase 2
~60
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
10,317 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,207 Previous Clinical Trials
489,655 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost patient count engaged in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial was first posted on October 30th 2020 and is actively recruiting patients at the moment. There are 11 sites attempting to enrol a total of 326 individuals in the study."

Answered by AI

What indications is NKTR-255 characterized for targeting?

"NKTR-255 is a widely used medication for pharmacotherapy. In addition, it may be employed to manage the progression of regionally advanced squamous cell carcinoma of the head and neck, metastatic squamous cell carcinoma of the head and neck (HNSCC), and other forms of Squamous Cell Carcinoma."

Answered by AI

Are there any locations in this state where the clinical trial is being conducted?

"START Center for Cancer Care, Memorial Sloan Kettering Cancer Centre and Mary Crowley Cancer Research are the three main clinical sites carrying out this research. Additionally, there are 11 other participating locations spread across the United States of America."

Answered by AI

Has NKTR-255 been used in any prior research studies?

"Currently, 121 active trials are assessing the effects of NKTR-255 with 30 of these studies in their third phase. Of those locations, most are situated in Dresden and Arizona; however, a total of 5533 sites have been running experiments on NKTR-255."

Answered by AI

Are participants still being welcomed for this research experiment?

"According to clinicaltrials.gov, the research is still seeking applicants and began on October 30th 2020 with an update posted March 31st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
How old are they?
18 - 65
What site did they apply to?
Honor Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of NKTR 255 in Combination With Cetuximab in Solid Tumors
2020. "Study of NKTR 255 in Combination With Cetuximab in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04616196.
~6 spots leftby Apr 2025
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