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Anti-tumor agent

GZ17-6.02 + Capecitabine for Metastatic Hormone Receptor Positive Breast Cancer (GEN602 Trial)

Phase 1
Waitlist Available
Research Sponsored by Genzada Pharmaceuticals USA, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor progression after receiving standard/approved therapies which may include chemotherapy, targeted agents, radio-immuno conjugates, check point inhibitors, where there is no approved therapy; or the patient is intolerant of standard of care or the patient declines standard of care treatment
Life expectancy of at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

GEN602 Trial Summary

This trial is testing a new drug, GZ17-6.02, to see if it is safe and works well against advanced solid tumors or lymphoma.

Eligible Conditions
  • Cancer
  • Stomach Cancer
  • Breast Cancer
  • Pancreatic Cancer
  • Colorectal Cancer
  • Sarcoma
  • Basal Cell Carcinoma
  • Cutaneous T-Cell Lymphoma
  • Squamous Cell Carcinoma
  • Prostate Cancer
  • Solid Tumors
  • Head and Neck Squamous Cell Carcinoma
  • Lymphoma

GEN602 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your tumor has grown after trying standard treatments like chemotherapy, targeted therapy, or immunotherapy. If there is no approved treatment available, if you cannot tolerate the standard treatment, or if you choose not to receive it, you may be eligible.
Select...
You are expected to live for at least 3 more months.

GEN602 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity
Recommended dose of GZ17-6.02 for future phase II clinical studies
maximum tolerated dose (MTD)
Secondary outcome measures
Antitumor effect
Apparent Volume of Distribution (Vd/F)
Area Under Concentration Curve
+4 more

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT02000882
60%
Nausea
50%
Vomiting
50%
Fatigue
50%
Anorexia
50%
Hypokalemia
40%
Urinary tract infection
40%
Diarrhea
40%
Mucositis oral
30%
Insomnia
30%
Palmar-plantar erythrodysesthesia
30%
Rash
20%
AST increased
20%
Seizure
20%
Blurred vision
20%
Falling down
20%
Bilirubin increased
20%
ALT increased
20%
Dehyrdration
20%
Constipation
20%
Hyponatremia
20%
Headache
10%
Facial swelling
10%
Hypertension
10%
Disorder ear
10%
Epilepsy
10%
Knee Pain
10%
Rash erythematous
10%
Anemia
10%
Hypovolemia
10%
Leukopenia
10%
Neutropenia
10%
Disorder eye
10%
Eye floaters
10%
Vision abnormal
10%
Stomatitis
10%
Hand-foot syndrome
10%
Legs restless
10%
Taste alteration
10%
Allergic reaction
10%
Thrush
10%
Creatinine serum increased
10%
Amylase increased
10%
Growth accelerated
10%
Hyperglycemia
10%
Dyspnea
10%
Epistaxis
10%
Colitis
10%
Dysphagia
10%
Weakness generalized
10%
Visual disturbance
10%
Abdominal Pain
10%
Canker sore oral
10%
Cramp abdominal
10%
Dry mouth
10%
Gastritis
10%
Hemorrhoids
10%
Pancreatitis
10%
Spasm oropharyngeal
10%
Hypocalcemia
10%
Lipase increased
10%
Dizziness
10%
Edema cerebral
10%
Neuropathy
10%
Numbness
10%
Somnolence
10%
Tremor
10%
Agitation
10%
Depression
10%
Emotional lability
10%
Incontinence urinary
10%
Renal function abnormal
10%
Potassium deficiency
10%
Muscle weakness
10%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
BKM120 Plus Capecitabine

GEN602 Trial Design

3Treatment groups
Experimental Treatment
Group I: Experimental: monotherapyExperimental Treatment1 Intervention
GZ17-6.02 given orally on a daily x 28 day schedule. This will be a dose escalation study.
Group II: Experimental: Combination with Capecitabine in Metastatic Hormone Receptor Positive Breast CancerExperimental Treatment2 Interventions
GZ17-6.02 given orally twice daily x 21 day schedule in combination with Capecitabine 825 mg/m2 orally twice daily for 14 days x 21 day schedule.
Group III: Experimental: Combination with Capecitabine in Metastatic Colorectal CancerExperimental Treatment2 Interventions
GZ17-6.02 given orally twice daily x 21 day schedule in combination with Capecitabine 850 mg/m2 orally twice daily for 14 days x 21 day schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved

Find a Location

Who is running the clinical trial?

Translational Drug DevelopmentOTHER
18 Previous Clinical Trials
938 Total Patients Enrolled
Genzada Pharmaceuticals USA, Inc.Lead Sponsor
Kathryn GazarikStudy DirectorTranslational Drug Development

Media Library

GZ17-6.02 (Anti-tumor agent) Clinical Trial Eligibility Overview. Trial Name: NCT03775525 — Phase 1
Stomach Cancer Research Study Groups: Experimental: Combination with Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer, Experimental: Combination with Capecitabine in Metastatic Colorectal Cancer, Experimental: monotherapy
Stomach Cancer Clinical Trial 2023: GZ17-6.02 Highlights & Side Effects. Trial Name: NCT03775525 — Phase 1
GZ17-6.02 (Anti-tumor agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03775525 — Phase 1

Frequently Asked Questions

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

What effects can be expected when using GZ17-6.02?

"The safety of GZ17-6.02 has been assigned a score of 1, given that the trial is only in its initial phase and there are limited data points to support both efficacy and safety."

Answered by AI

Is there still availability for enrolment in this clinical trial?

"According to clinicialtrials.gov this medical trial is still seeking enrolment from volunteers; its initial posting date was March 1st 2019 and the most recent update happened on May 11th 2022."

Answered by AI

What is the current number of enrollees for this trial?

"Verified, clinicaltrials.gov attests to the fact that this trial is actively searching for participants since it was initially posted on March 1st 2019 and last revised on May 11th 2022. Currently, 127 individuals must be enrolled from one site."

Answered by AI
~21 spots leftby Mar 2025