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Small Molecule Inhibitor

BLZ945 for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase I: Patients with advanced/metastatic solid tumors, with measurable or unmeasurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Phase I: Patients with a site of disease amenable to biopsy, and willing to undergo a new tumor biopsy at screening, and during treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for blz945 single agent and 4.4 years for blz945 in combination with pdr001
Awards & highlights

Study Summary

This trial is testing a new cancer drug, BLZ945, to see if it is safe and effective when given alone or with another drug, PDR001.

Eligible Conditions
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for blz945 single agent and 4.4 years for blz945 in combination with pdr001
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until first documented progression or death due to any cause, assessed up to 3.1 years for blz945 single agent and 4.4 years for blz945 in combination with pdr001 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Dose Intensity of BLZ945
Phase I: Dose Intensity of PDR001
Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
+5 more
Secondary outcome measures
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (4d on/10d Off Regimen, BID Dosing)
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of BLZ945 (Q1W Regimen, BID Dosing)
Phase I and II: Area Under the Serum Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC0-24hr) of BLZ945 (4d on/10d Off Regimen, QD Dosing)
+38 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
83%
Aspartate aminotransferase increased
67%
Alanine aminotransferase increased
67%
Diarrhoea
50%
Pyrexia
50%
Abdominal distension
50%
Hyperphosphataemia
33%
Blood bilirubin increased
33%
Oedema peripheral
33%
Anaemia
33%
Abdominal pain
33%
Nausea
33%
Fatigue
33%
Neutrophil count decreased
33%
Pruritus
33%
Rash
17%
Epistaxis
17%
Productive cough
17%
Liver carcinoma ruptured
17%
Tinea cruris
17%
Dysgeusia
17%
Oesophageal varices haemorrhage
17%
Hyperglycaemia
17%
Blood creatinine increased
17%
Hypokalaemia
17%
Vomiting
17%
Rash pustular
17%
Sinusitis
17%
Blood creatine phosphokinase increased
17%
Weight decreased
17%
Gamma-glutamyltransferase increased
17%
Platelet count decreased
17%
Arthralgia
17%
Myalgia
17%
Insomnia
17%
Dyspnoea exertional
17%
Hot flush
17%
Headache
17%
Cough
17%
Pneumonitis
17%
Hyperthyroidism
17%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: FGF401 120 mg + PDR001 300 mg
All Patients of Combination Dose
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted

Trial Design

2Treatment groups
Experimental Treatment
Group I: BLZ945 single agentExperimental Treatment1 Intervention
BLZ945 administered as single agent
Group II: BLZ945 + PDR001Experimental Treatment2 Interventions
BLZ945 administered in combination with PDR001
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2700

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,161 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors
2016. "A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02829723.
~23 spots leftby Apr 2025
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