NKTR-255 for Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Head and Neck Squamous Cell Carcinoma (HNSCC)+4 MoreNKTR-255 - Drug
Eligibility
18+
All Sexes
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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
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Skin Squamous Cell Carcinoma
  • Cervical Cancer
  • Colorectal Cancer
  • Squamous Cell Anal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

6 Primary · 14 Secondary · Reporting Duration: Through study completion, an expected average of 1 year

Day 60
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 with Cetuximab
Year 1
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
Change in tumor cells levels after administration of NKTR-255 in combination with cetuximab and NKTR-255 monotherapy
Changes in gene expression after administration of NKTR-255 in combination with cetuximab and NKTR-255 monotherapy
Clearance (CL) for NKTR-255 and cetuximab
Efficacy of NKTR-255 with Cetuximab
Efficacy of NRTR-255 with Cetuximab
Half-life of NKTR-255 and cetuximab
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
Maximum Plasma Concentration (Cmax) for NKTR-255 and cetuximab
ORR by RECIST 1.1 of NKTR-255 monotherapy in R/R cSCC, ASCC, and cervical cancer
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
Overall Survival (OS) of NKTR-255 monotherapy and in combination with Cetuximab
Progression-Free Survival (PFS) of NKTR-255 monotherapy and in combination with Cetuximab
The development of anti-drug antibodies (ADA) against NKTR-255 and cetuximab
The maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) or NKTR-255 in combination with cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
Volume of Distribution of NKTR-255 and cetuximab

Trial Safety

Safety Progress

1 of 3

Similar Trials

Side Effects for

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

Trial Design

7 Treatment Groups

Dose Expansion of NKTR-255 with Cetuximab - Cohort C
1 of 7
Dose Expansion of NKTR-255 with Cetuximab - Cohort D
1 of 7
Dose expansion of NKTR-255 with Cetuximab
1 of 7
Dose Expansion of NKTR-255 with Cetuximab - Cohort A
1 of 7
Dose Expansion of NKTR-255 with Cetuximab - Cohort B
1 of 7
Dose Expansion of NKTR-255 with Cetuximab - Cohort E
1 of 7
Dose Escalation of NKTR-255 with Cetuximab
1 of 7

Experimental Treatment

326 Total Participants · 7 Treatment Groups

Primary Treatment: NKTR-255 · No Placebo Group · Phase 1 & 2

Dose Expansion of NKTR-255 with Cetuximab - Cohort CExperimental Group · 2 Interventions: NKTR-255, Cetuximab · Intervention Types: Drug, Drug
Dose Expansion of NKTR-255 with Cetuximab - Cohort DExperimental Group · 2 Interventions: NKTR-255, Cetuximab · Intervention Types: Drug, Drug
Dose expansion of NKTR-255 with Cetuximab
Drug
Experimental Group · 1 Intervention: NKTR-255 · Intervention Types: Drug
Dose Expansion of NKTR-255 with Cetuximab - Cohort AExperimental Group · 2 Interventions: NKTR-255, Cetuximab · Intervention Types: Drug, Drug
Dose Expansion of NKTR-255 with Cetuximab - Cohort BExperimental Group · 2 Interventions: NKTR-255, Cetuximab · Intervention Types: Drug, Drug
Dose Expansion of NKTR-255 with Cetuximab - Cohort EExperimental Group · 2 Interventions: NKTR-255, Cetuximab · Intervention Types: Drug, Drug
Dose Escalation of NKTR-255 with CetuximabExperimental Group · 2 Interventions: NKTR-255, Cetuximab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an expected average of 1 year

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor
54 Previous Clinical Trials
9,789 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,068 Previous Clinical Trials
475,374 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically confirmed diagnosis of a locally advanced or metastatic cancer.
Patients must have received or were intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease.

Who else is applying?

What state do they live in?
Arizona50.0%
Texas50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Honor Health100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%