Trials / Unknown
UnknownNCT03775525
Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer
A Phase I/Ib, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination With Capecitabine, Given Orally on a Daily Schedule in Patients With Advanced Solid Tumors or Lymphoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 127 (estimated)
- Sponsor
- Genzada Pharmaceuticals USA, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase I/Ib study is a Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination with Capecitabine, Given Orally on a Daily Schedule in Patients with Advanced Solid Tumors or Lymphoma
Detailed description
This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a novel anti-cancer drug, GZ17-6.02 administered to patients with advanced solid tumors or lymphoma, which have progressed after receiving standard/approved therapy or where there is no approved therapy. This study will determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of GZ17-6.02 monotherapy and in combination with standard-of-care oncology treatments and to establish the dose of GZ17-6.02 recommended for future monotherapy and combination therapies phase II oncology clinical studies.
Conditions
- Advanced Cancer
- Gastric Cancer
- Breast Cancer
- Pancreatic Cancer
- Prostate Cancer Metastatic
- Colo-rectal Cancer
- Solid Tumor
- Solid Carcinoma
- Solid Carcinoma of Stomach
- Cancer of Stomach
- Lymphoma
- Sarcoma
- Cutaneous T Cell Lymphoma
- Head and Neck Squamous Cell Carcinoma
- Basal Cell Carcinoma
- Cutaneous T-cell Lymphoma
- Cutaneous Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GZ17-6.02 | Super enhancer Inhibition |
| DRUG | Capecitabine | antimetabolite |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2023-05-01
- Completion
- 2023-12-01
- First posted
- 2018-12-14
- Last updated
- 2022-12-23
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03775525. Inclusion in this directory is not an endorsement.