GZ17-6.02 + Capecitabine for Metastatic Hormone Receptor Positive Breast Cancer

(GEN602 Trial)

Recruiting at 3 trial locations

Overseen By MedInfo

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genzada Pharmaceuticals USA, Inc.

Must not be taking: MAOIs, Class 1A/III antiarrhythmics

Disqualifiers: Cardiac disease, Active infections, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 21-28 days per cycle

127 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you must discontinue any prohibited medications listed in Appendix 6. It's best to discuss your current medications with the trial team to ensure they are not on the prohibited list.

Is the combination of GZ17-6.02 and Capecitabine safe for humans?

Capecitabine, also known as Xeloda, has been shown to be generally safe and well-tolerated in patients with metastatic breast cancer, although some patients may experience side effects at higher doses. Adjusting the dose can improve tolerability without reducing effectiveness. ^{1 2 3 4 5}

What makes the drug GZ17-6.02 + Capecitabine unique for treating metastatic hormone receptor-positive breast cancer?

GZ17-6.02 combined with capecitabine is unique because it potentially offers a novel approach by combining a new investigational drug (GZ17-6.02) with capecitabine, which is already known for its effectiveness in hormone receptor-positive breast cancer. This combination may enhance treatment efficacy by leveraging the strengths of both components, although specific details about GZ17-6.02's mechanism or benefits are not provided in the available research. ^{6 7 8 9 10}

What data supports the effectiveness of the drug Capecitabine for treating metastatic hormone receptor-positive breast cancer?

Research suggests that Capecitabine is more effective in treating hormone receptor-positive metastatic breast cancer compared to hormone receptor-negative cases. It is also considered an active and well-tolerated option for metastatic breast cancer, showing potential benefits when used in combination with other cancer treatments. ^{2 6 8 11 12}

Who Is on the Research Team?

Kathryn Gazarik

Principal Investigator

Translational Drug Development

Are You a Good Fit for This Trial?

Inclusion Criteria

Urinalysis: No clinically significant abnormalities

Patients with a pathologically confirmed diagnosis of advanced solid tumors or lymphoma

Albumin ≥ 3.0 g/dL within seven days of initiating protocol treatment

Exclusion Criteria

You are allergic or have had bad reactions to capecitabine or 5-FU.

You are currently taking any experimental medication.

You are currently taking medication called MAOIs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GZ17-6.02 monotherapy or in combination with Capecitabine on a 21-day or 28-day schedule

21-28 days per cycle

Regular visits as per cycle schedule

Dose Escalation

Determination of maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of GZ17-6.02

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• GZ17-6.02

How Is the Trial Designed?

Group I: Experimental: monotherapy Experimental Treatment 1 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 Cancer Experimental Treatment 2 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 Cancer Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Genzada Pharmaceuticals USA, Inc.

Lead Sponsor

Trials

2

Recruited

170+

Translational Drug Development

Collaborator

Trials

19

Recruited

1,000+

Published Research Related to This Trial

Capecitabine is a well-tolerated treatment for metastatic breast cancer, showing minimal side effects like myelosuppression and hair loss, which makes it a promising option for combination therapies with other anticancer drugs.

Ongoing phase II/III trials are investigating the use of capecitabine in early breast cancer treatment, and preliminary results indicate that it may provide significant benefits when used as part of adjuvant and neoadjuvant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer. Fumoleau, P., Cameron, D.[2019]

In a study of 95 women aged 55 and older with advanced breast cancer, oral capecitabine showed a higher overall response rate of 30% compared to 16% for the intravenous CMF regimen, indicating its effectiveness as a first-line treatment.

Capecitabine was generally well tolerated, with fewer instances of alopecia and myelosuppression compared to CMF, although it did lead to more cases of diarrhea and hand-foot syndrome, which were manageable with dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Oshaughnessy, JA., Blum, J., Moiseyenko, V., et al.[2022]

In a phase II study involving 47 women with HER2-positive metastatic breast cancer, the combination of capecitabine, vinorelbine, and trastuzumab resulted in a confirmed response rate of 67%, exceeding the threshold needed to consider the treatment promising.

The treatment also showed a median progression-free survival of 11.3 months and a median overall survival of 28.5 months, indicating significant efficacy for patients receiving this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II interventional study (N0337) of capecitabine in combination with vinorelbine and trastuzumab for first- or second-line treatment of HER2-positive metastatic breast cancer: a north central cancer treatment group trial. Tan, WW., Allred, JB., Salim, M., et al.[2021]

A retrospective analysis of 141 patients with metastatic breast cancer found that starting capecitabine at a lower dose of 2000 mg/m2/day resulted in fewer severe toxic effects compared to the standard dose of 2500 mg/m2/day, while maintaining similar response rates.

The study suggests that individualizing the dose of capecitabine can improve tolerability without compromising efficacy, highlighting the need for further research through a phase III trial to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower dose capecitabine has a more favorable therapeutic index in metastatic breast cancer: retrospective analysis of patients treated at M. D. Anderson Cancer Center and a review of capecitabine toxicity in the literature. Hennessy, BT., Gauthier, AM., Michaud, LB., et al.[2020]

The study evaluated the combination of S-1 and T-DM1 in 13 patients with HER2-positive metastatic breast cancer, determining that S-1 can be safely administered at a maximum tolerable dose of 80 mg/m2/day alongside T-DM1 without significant dose-limiting toxicities.

One dose-limiting toxicity was observed at the lower dose level, but no severe adverse events occurred at the higher dose, suggesting that this combination treatment is a promising and safe option for patients previously treated with trastuzumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab Emtansine (T-DM1) Plus S-1 in Patients with Trastuzumab-Pretreated HER2-Positive Advanced or Metastatic Breast Cancer: A Phase Ib Study. Kojima, Y., Yoshie, R., Kawamoto, H., et al.[2019]

Citations

1. Greece pubmed.ncbi.nlm.nih.gov

Capecitabine after anthracycline and taxane exposure in HER2-negative metastatic breast cancer patients: response, survival and prognostic factors. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Phase II interventional study (N0337) of capecitabine in combination with vinorelbine and trastuzumab for first- or second-line treatment of HER2-positive metastatic breast cancer: a north central cancer treatment group trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Capecitabine monotherapy is efficient and safe in all line settings in patients with metastatic and advanced breast cancer. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of capecitabine monotherapy as the first-line treatment of metastatic HER2-negative breast cancer. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Lower dose capecitabine has a more favorable therapeutic index in metastatic breast cancer: retrospective analysis of patients treated at M. D. Anderson Cancer Center and a review of capecitabine toxicity in the literature. [2020]

9. China pubmed.ncbi.nlm.nih.gov

Capecitabine combined with weekly docetaxel in Chinese patients > 65 years with anthracycline-resistant metastatic breast cancer. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Trastuzumab Emtansine (T-DM1) Plus S-1 in Patients with Trastuzumab-Pretreated HER2-Positive Advanced or Metastatic Breast Cancer: A Phase Ib Study. [2019]

11. Greece pubmed.ncbi.nlm.nih.gov

Antitumor activity of chemoendocrine therapy in premenopausal and postmenopausal models with human breast cancer xenografts. [2018]

12. Cyprus pubmed.ncbi.nlm.nih.gov

Capecitabine/cisplatin doublet in anthracycline and taxane pretreated and HER-2 negative metastatic breast carcinoma patients. [2022]