Single-agent KFA115 for Nasopharyngeal Cancer

Novartis Investigative Site, Toronto, Canada
Nasopharyngeal Cancer+60 More ConditionsKFA115 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests the safety and side effects of two drugs for advanced cancers, to find the safest and most effective dose.

Eligible Conditions
  • Nasopharyngeal Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Stage IVC Nasopharyngeal Carcinoma
  • Ovarian Cancer
  • Stage III Nasopharyngeal Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Epstein-Barr Virus Positive Nasopharyngeal Carcinoma
  • Oral Cavity Squamous Cell Carcinoma (Stage III)
  • Epithelial Ovarian Cancer
  • Nasopharyngeal Carcinoma
  • Unresectable Head and Neck Squamous Cell Carcinoma
  • High Microsatellite Instability Colorectal Carcinoma
  • Squamous Cell Carcinoma of the Mouth
  • Non-Small Cell Lung Cancer
  • Stage IV Nasopharyngeal Carcinoma
  • Stage II Nasopharyngeal Carcinoma
  • Squamous Cell Carcinoma of the Larynx
  • Stage I Nasopharyngeal Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma (Metastatic)
  • Stage IV Oral Cavity Squamous Cell Carcinoma
  • Skin Cancer
  • Stage IVA Nasopharyngeal Carcinoma
  • Oral Squamous Cell Carcinoma
  • Renal Cell Carcinoma
  • Thymic Carcinoma
  • Anal Cancer
  • Mesothelioma
  • Esophageal Cancer
  • Metastatic Nasopharyngeal Undifferentiated Carcinoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

5 Primary · 10 Secondary · Reporting Duration: 35 months for KFA115 in combination with tislelizumab

28 days
Incidence and severity of dose limiting toxicities (DLTs) during the DLT evaluation period of single-agent KFA115 (dose escalation only)
35 months
Best overall response (BOR) per RECIST v1.1
Dose intensity
Duration of response (DOR) per RECIST v1.1
Frequency of dose interruptions, reductions
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Progression free survival (PFS) per RECIST v1.1
Time to progression (TTP) per RECIST v1.1
Month 35
The number of participants with anti-drug antibodies (ADA)
56 days
Incidence and severity of dose limiting toxicities (DLTs) during the DLT evaluation period of KFA115 in combination with tislelizumab (dose escalation only)
Month 35
Area under the concentration time curve (AUC) of KFA115 or tislelizumab
Elimination half-life (T1/2) of KFA115 or tislelizumab
Minimum plasma or serum concentration (Cmin) of KFA115 or tislelizumab
Peak plasma or serum concentration (Cmax) of KFA115 or tislelizumab
Plasma

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Single-agent KFA115
1 of 3
KFA115 run-in (1 cycle) + tislelizumab
1 of 3
KFA115 + tislelizumab
1 of 3

Experimental Treatment

220 Total Participants · 3 Treatment Groups

Primary Treatment: Single-agent KFA115 · No Placebo Group · Phase 1

Single-agent KFA115
Drug
Experimental Group · 1 Intervention: KFA115 · Intervention Types: Drug
KFA115 run-in (1 cycle) + tislelizumabExperimental Group · 2 Interventions: KFA115, tislelizumab · Intervention Types: Drug, Drug
KFA115 + tislelizumabExperimental Group · 2 Interventions: KFA115, tislelizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tislelizumab
2016
Completed Phase 1
~230

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 35 months for kfa115 in combination with tislelizumab

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,771 Previous Clinical Trials
3,830,014 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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Frequently Asked Questions

What potential adverse effects could arise from single-agent KFA115?

"Due to the limited data available from Phase 1 clinical trials, Single-agent KFA115 garnered a safety rating of 1 on our team's scale." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies available to participate in this experiment?

"Clinicaltrials.gov has confirmed that this medical trail is actively seeking patients, the listing having been created on October 26th 2022 and last updated on May 8th of 2023." - Anonymous Online Contributor

Unverified Answer

Is this medical study being conducted in various parts of the United States?

"At present, 5 centres are actively enrolling participants for this trial; with locations in Toronto, Shatin New Territories and Shatin. To reduce the time spent commuting if you become part of the study it is advised to choose a centre closest to your residence." - Anonymous Online Contributor

Unverified Answer

How many participants are eligible to partake in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the study is still enlisting participants and commenced on October 26th 2022. It was last modified on May 8th 2023 with a total of 220 patients being accepted from 5 medical sites." - Anonymous Online Contributor

Unverified Answer

What results are researchers hoping to achieve through this clinical trial?

"As specified by the trial sponsor, Novartis Pharmaceuticals, primary outcomes will be ascertained over a period of 28 days. Specifically, they are gaugeing incidents and levels dose limiting toxicities (DLTs) during their evaluation phase alongside immunogenicity when tislelizumab is administered in combination with KFA115. Secondary objectives encompass determining those that develop anti-drug antibodies (ADA), duration of response per RECIST v1.1 definition from first documented response to first observed progression or death due to underlying cancer, and best overall recordable responses according to RECIST v1.1 specifications." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.