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ZN-A-1041 Combinations for Breast Cancer
Phase 1
Recruiting
Led By Anders Carey K, MD
Research Sponsored by Suzhou Zanrong Pharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HER2 positive is defined as Immunohistochemistry (IHC) (++) and Fluorescence In Situ Hybridization (FISH) positive, or IHC (+++).
- Patients with HER2-positive gastric cancer must have previously received trastuzumab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will assess safety & effectiveness of ZN-A-1041 to treat advanced solid tumors in patients with or without brain metastases.
Who is the study for?
This trial is for adults with advanced HER2-positive solid tumors, including breast and gastric cancers. Participants must have tried certain treatments like Trastuzumab or a taxane without success, or be intolerant to them. Those with brain metastases can join if they meet specific criteria regarding prior treatments and stability of their condition.Check my eligibility
What is being tested?
The trial tests ZN-A-1041 alone or in combination with other cancer drugs (T-DM1, PHESGO/Herceptin plus Perjeta, T-Dxd) at various doses to assess safety, tolerability, how the body processes the drug (pharmacokinetics), and effectiveness against HER2-positive tumors.See study design
What are the potential side effects?
Potential side effects are not listed but may include typical reactions to cancer therapies such as nausea, fatigue, allergic reactions to medication components, infusion-related symptoms from IV drugs, and possible interactions when combined with other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is HER2 positive based on specific tests.
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I have HER2-positive stomach cancer and was treated with trastuzumab.
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I am fully active or can carry out light work.
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I have an advanced solid tumor that is HER2-positive and cannot be surgically removed.
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I have had Trastuzumab, Pertuzumab, T-DM1, and a taxane for my HER2-positive breast cancer.
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I have HER2-positive breast cancer and have been treated with or declined Trastuzumab, Pertuzumab, T-DM1, and a taxane.
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I have HER2-positive stomach cancer and was treated with Trastuzumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RP2D Dose
The Incidence of Treatment-Emergent Adverse Events of ZN-A-1041 as a monotherapy in Phase 1a
Gilles de la Tourette syndrome
Secondary outcome measures
Brain Diseases, Metabolic
Brain Diseases, Metabolic
Progression free survival(PFS)
+2 moreTrial Design
13Treatment groups
Experimental Treatment
Group I: ZN-A-1041 800mgExperimental Treatment1 Intervention
Phase 1a:
Subjects will be given ZN-A-1041 orally 800mg Bid, for 21days as one cycle
Group II: ZN-A-1041 600mgExperimental Treatment1 Intervention
Phase 1a:
Subjects will be given ZN-A-1041 orally 600mg Bid, for 21days as one cycle
Group III: ZN-A-1041 50mgExperimental Treatment1 Intervention
Phase 1a:
Subjects will be given ZN-A-1041 orally 50mg Bid, for 21days as one cycle
Group IV: ZN-A-1041 400mgExperimental Treatment1 Intervention
Phase 1a:
Subjects will be given ZN-A-1041 orally 400mg Bid, for 21days as one cycle
Group V: ZN-A-1041 200mgExperimental Treatment1 Intervention
Phase 1a:
Subjects will be given ZN-A-1041 orally 200mg Bid, for 21days as one cycle
Group VI: ZN-A-1041 100mgExperimental Treatment1 Intervention
Phase 1a:
Subjects will be given ZN-A-1041 orally 100mg Bid, for 21days as one cycle
Group VII: ZN-A-1041 1000mgExperimental Treatment1 Intervention
Phase 1a:
Subjects will be given ZN-A-1041 orally 1000mg Bid, for 21days as one cycle
Group VIII: 1c: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.Experimental Treatment1 Intervention
Phase 1c Arm2:
The dose levels of ZN-A-1041 in the Phase 1c study will be the recommended doses determined in the Phase 1b study.
Group IX: 1c: ZN-A-1041 + T-DM1 3.6 mg/kg iv.Experimental Treatment1 Intervention
Phase 1c Arm1:
The dose levels of ZN-A-1041 in the Phase 1c study will be the recommended doses determined in the Phase 1b study.
Group X: 1c: ZN-A-1041 + Herceptin plus Perjeta/PHESGOExperimental Treatment1 Intervention
Phase 1c Arm3:
The dose levels of ZN-A-1041 in the Phase 1c study will be the recommended doses determined in the Phase 1b study.
Group XI: 1b: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.Experimental Treatment1 Intervention
Phase 1b Arm2:
If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2)
If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.
Group XII: 1b: ZN-A-1041 + T-DM1 3.6 mg/kg iv.Experimental Treatment1 Intervention
Phase 1b Arm1:
If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2)
If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.
Group XIII: 1b: ZN-A-1041 + PHESGO / Herceptin plus PerjetaExperimental Treatment1 Intervention
Phase 1b Arm3:
If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2)
If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.
Find a Location
Who is running the clinical trial?
Suzhou Zanrong Pharma LimitedLead Sponsor
1 Previous Clinical Trials
84 Total Patients Enrolled
Anders Carey K, MDPrincipal InvestigatorDuke Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a brain lesion that needs immediate treatment.If you have cancer that has spread to your brain, you must have previously received treatment for HER2-positive breast or gastric cancer. You cannot have had recent local treatment, unless your disease is stable or progressing. If you have had previous treatment with certain medications, you must wait at least 2 weeks before starting this trial.I am fully active or can carry out light work.I don't need immediate brain treatment and either had stable brain treatment over 2-4 weeks ago or never had it.I may have cancer spread to the lining of my brain and spinal cord, but only if I'm in Phase 1b of the trial.I have had Trastuzumab, Pertuzumab, T-DM1, and a taxane for my HER2-positive breast cancer.I've had treatments for HER2+ breast cancer but my disease hasn't improved or has returned.I have HER2-positive stomach cancer and was treated with Trastuzumab.I have an advanced solid tumor that is HER2-positive and cannot be surgically removed.I have HER2-positive stomach cancer and was treated with trastuzumab.You have a relapsed or refractory cancer and have not responded well to existing treatments or cannot tolerate them. If you have HER2-positive breast or gastric cancer, you must have received specific medications before. Your cancer must be measurable or non-measurable according to a specific standard called RECIST 1.1.I am experiencing worsening neurological symptoms like headaches or blurred vision.I have HER2-positive breast cancer and have been treated with or declined Trastuzumab, Pertuzumab, T-DM1, and a taxane.I am taking more than 2 mg of dexamethasone daily for brain metastases.I don't need immediate brain treatment and either had stable brain lesions after treatment or haven't had brain treatment yet.My cancer is HER2 positive based on specific tests.I need medication for epilepsy, but only take Levetiracetam for stable seizures.I have waited at least 2 weeks after my last cancer treatment to join this trial, or I have HER2+ breast cancer with no prior specific treatment except Herceptin, Perjeta, or PHESGO and taxane.I have HER2+ breast cancer, treated but not cured with specific drugs, and my cancer can be measured.I have advanced or metastatic HER2+ breast cancer that cannot be surgically removed.I last received cancer treatment like TKI, chemotherapy, or antibody therapy over 2 weeks ago.I do not have cancer that has spread to my brain.I cannot provide a summary without specific criteria.I haven't taken specific cancer drugs before, but may have used some for a short time.My brain MRI and clinical assessment show I don't have CNS issues.My condition did not improve with current treatments or I couldn't tolerate them.
Research Study Groups:
This trial has the following groups:- Group 1: 1b: ZN-A-1041 + PHESGO / Herceptin plus Perjeta
- Group 2: 1c: ZN-A-1041 + T-DM1 3.6 mg/kg iv.
- Group 3: 1b: ZN-A-1041 + T-DM1 3.6 mg/kg iv.
- Group 4: 1c: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.
- Group 5: 1c: ZN-A-1041 + Herceptin plus Perjeta/PHESGO
- Group 6: 1b: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.
- Group 7: ZN-A-1041 50mg
- Group 8: ZN-A-1041 100mg
- Group 9: ZN-A-1041 200mg
- Group 10: ZN-A-1041 400mg
- Group 11: ZN-A-1041 600mg
- Group 12: ZN-A-1041 800mg
- Group 13: ZN-A-1041 1000mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the combination of 1c: ZN-A-1041 + Herceptin plus Perjeta/PHESGO received clearance from the US Food and Drug Administration?
"The safety of 1c: ZN-A-1041 + Herceptin plus Perjeta/PHESGO is rated a 1 as it is currently under Phase 1 investigation and there are limited evidence to vouch for its efficacy and risk profile."
Answered by AI
What are the outcomes expected from this exploration?
"As reported by the study sponsor, Suzhou Zanrong Pharma Limited, this trial will assess The Incidence of Treatment-Emergent Adverse Events of ZN-A-1041 as a monotherapy over an average 1 year period. In addition to that primary outcome measure, Progression free survival(PFS) and Cmax/ AUC plasma levels of ZN-A-1041 and its main metabolites in Phases 1a,1b and 1c are also being evaluated for secondary outcomes."
Answered by AI
How many participants are being monitored in this experiment?
"Affirmative. The clinical trial registry indicates that the study, which was initially listed on October 15th 2020, is actively searching for participants. 210 volunteers are needed from 7 distinct sites."
Answered by AI
Are there numerous healthcare facilities conducting this medical trial in Canada?
"This study is currently operational at 7 distinct health centres. These locations are Tucson, Detroit and Whittier in addition to other sites closer to you; selecting the nearest site will help minimize travel demands should you choose to participate."
Answered by AI
Are there any vacancies remaining for participants in this research study?
"Affirmative. The pertinent information found on clinicaltrials.gov reveals that the trial, initially posted in October of 2020, is open for enrollment and requires 210 participants from 7 sites to complete it."
Answered by AI
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