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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new cancer drug called GZ17-6.02. It is for patients with advanced cancers that haven't responded to other treatments. The study will check if the drug is safe, how it works in the body, and its effects on cancer.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
maximum tolerated dose (MTD)

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Mucositis
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Bone pain
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
877 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
Lymphoma Research Study Groups: Experimental: Combination with Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer, Experimental: Combination with Capecitabine in Metastatic Colorectal Cancer, Experimental: monotherapy
Lymphoma 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
~19 spots leftby Dec 2025
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