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Advanced Solid TumorsPhase 1NCT04487236

Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors

A Phase 1 study testing ZN-A-1041 50mg BID, ZN-A-1041 100mg BID and ZN-A-1041 200mg BID in people with Advanced Solid Tumors and HER2-positive Breast Cancer, run by Suzhou Zanrong Pharma Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ZN-A-1041 50mg BID, ZN-A-1041 100mg BID and ZN-A-1041 200mg BID
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteChina
Study dates
15 Oct 2020to 16 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 11. ECOG performance status of 0 to 1 2. HER2-positive is defined as Immunohistochemistry (IHC) (++) and Fluorescence In Situ Hybridization (FISH) positive, or IHC (+++).
  • 3. Phase 1a study will enroll patients with unresectable or metastatic HER2-positive advanced solid tumor; Phase 1b study will enroll patients with unresectable locally-advanced or metastatic HER2+ breast cancer.
  • For patients who have no brain metastases, the following criteria should be met:
  • Patients should be relapsed or refractory to existing therapy(ies) or have been intolerant of such therapies
  • Have at least one extracranial measurable lesion by RECIST v1. 1 ii. For patients with brain metastasis, the following criteria should be met:
  • 1) Have received prior treatment or patient declined the above treatment; 2) Patients with HER2-positive gastric cancer must have previously received Trastuzumab 3) Do not require immediate local treatment during the trial period, and meet either of the following two criteria:
Show all 18Show fewer
  • For patients who have received previous local treatment (surgery, whole brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS)) for brain metastases, stable or progression of intracranial lesions is required. Interval from prior local therapy could be 3 weeks from WBRT and 2 weeks from SRS.
  • Symptomatic or not, patient has not received previous local treatment (surgery or radiotherapy) for brain metastases as long as no local therapy is needed during the trial period.
  • In Phase 1a, for patients who have received previous tyrosine kinase inhibitor (TKI) treatment, chemotherapy, antibody, or antibody-drug conjugate (ADC), the interval between the last treatment and the first administration of the study drug in this trial should be at least 2 weeks. In Phase 1b, for patients who have received previous trastuzumab or other antibodies, the interval between the last treatment and the first administration of the study drug in this trial should be at least 3 weeks.
  • 4. Phase 1c study will enroll patients with unresectable locally-advanced or metastatic HER2+ breast cancer with brain metastases.
  • For patients with brain metastasis, patients do not require immediate local treatment during the trial period, and meet either of the following two criteria:
  • For patients who have received previous local treatment (surgery, whole brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS)) for brain metastases, stable or progression of intracranial lesions is required. Interval from prior local therapy could be 3 weeks from WBRT, 2 weeks from SRS and 4 weeks from surgery
  • Symptomatic or not, patient has not received previous local treatment (surgery or radiotherapy) for brain metastases as long as no local therapy is needed during the trial period
  • Have at least one measurable lesion and is suitable for accurate repeated assessable by RECIST 1.1, and the patient has an imaging-diagnosable intracranial lesion;
  • Patients should not include suspected or confirmed meningeal metastases;
  • The patient had no disease progression with previous 12 weeks' capecitabine therapy;
  • No capecitabine therapy within 6 months;
  • Patient should not previously treat with a tyrosine kinase inhibitor (TKI). Previous treatment with trastuzumab or other antibodies should be at least 3 weeks apart from the first treatment

Who cannot join

  • Subjects who have participated in any clinical study or received any clinical study drug within 4 weeks prior to the first administration
  • There is evidence that other primary tumors are present at the same time;
  • Previous cumulative dose of doxorubicin exceeds 360mg/m2 or its equivalent dose of similar drugs;
  • CNS Exclusion - Based on screening brain MRI and clinical assessment
  • Progressive neurologic impairment or increased intracranial pressure (including nausea, vomiting, blurred vision, headache, epilepsy, etc.)
  • Any intracranial lesion thought to require immediate local therapy
  • Require antiepileptic treatment (except for these patients with stable seizures require continuous Levetiracetam therapy).
  • Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer hospital Chinese academy of medical sciences

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors

This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors.

The study will consist of three phases: phase 1a (dose escalation with ZN-A-1041 monotherapy), phase 1b (dose escalation with ZN-A-1041 in combination with Capecitabine and Trastuzumab) and phase 1c (dose expansion with ZN-A-1041 in combination with Capecitabine and Trastuzumab).

Read the detailed description

Phase 1a of the study will adopt the "modified 3+3" dose escalation design with a total of 7 planned dose levels. Patients with HER2-positive advanced solid tumor (including those with brain metastases) will be enrolled to receive a single-dose administration of ZN-A-1041 followed by multiple-dose administration of ZN-A-1041.

Phase 1b of the study will adopt the "traditional 3+3" dose escalation design. In phase 1b, patients with HER2-positive advanced breast cancer (including those with brain metastases) will be enrolled to receive multiple doses of ZN-A-1041 in combination with Capecitabine and Trastuzumab.

In phase 1c patients with HER2-positive breast cancer with brain metastases were planned to be enrolled to receive ZN-A-1041 in combination with Capecitabine and Trastuzumab The dose levels will be determined based on the recommended doses obtained from the Phase 1b study, and the possible changes in the dosage form and the food effect study, which will be decided by the sponsor and the investigator after discussion.

Each phase of the study includes a screening period, a treatment period and a follow-up period. During the trial, the safety, tolerability, PK and efficacy data of ZN-A-1041 as monotherapy and in combination with Capecitabine and Trastuzumab in the subjects will be collected and analyzed, thereby providing RP2D for the subsequent clinical trials.

Being tested
ZN-A-1041 50mg BID, ZN-A-1041 100mg BID, ZN-A-1041 200mg BID, ZN-A-1041 400mg BID, ZN-A-1041 600mg BID
Keywords
Phase 1, Advanced Solid Tumors, HER2-Positive Breast Cancer, Brain metastases
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZN-A-1041 50mg BIDDrug

    Also called ZN-A-1041 Enteric Capsules

    Orally 21days for one cycle

  • ZN-A-1041 100mg BIDDrug

    Also called ZN-A-1041 Enteric Capsules

    Orally 21days for one cycle

  • ZN-A-1041 200mg BIDDrug

    Also called ZN-A-1041 Enteric Capsules

    Orally 21days for one cycle

  • ZN-A-1041 400mg BIDDrug

    Also called ZN-A-1041 Enteric Capsules

    Orally 21days for one cycle

  • ZN-A-1041 600mg BIDDrug

    Also called ZN-A-1041 Enteric Capsules

    Orally 21days for one cycle

  • ZN-A-1041 800mg BIDDrug

    Also called ZN-A-1041 Enteric Capsules

    Orally 21days for one cycle

  • ZN-A-1041 1000mg BIDDrug

    Also called ZN-A-1041 Enteric Capsules

    Orally 21days for one cycle

  • ZN-A-1041 Level 1 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First CycleDrug

    Also called ZN-A-1041 Enteric Capsules

    ZN-A-1041 level 1 BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle

  • ZN-A-1041 Level 2 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First CycleDrug

    Also called ZN-A-1041 Enteric Capsules

    ZN-A-1041 level 2 BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle

  • ZN-A-1041 MAD +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First CycleDrug

    Also called ZN-A-1041 Enteric Capsules

    ZN-A-1041 MAD BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle

  • ZN-A-1041+Capecitabine + Trastuzumab 8 mg/kg iv. First CycleDrug

    Also called ZN-A-1041 Enteric Capsules

    Base on 1b ZN-A-1041 dose Base on 1b Capecitabine dose Base on 1b Trastuzumab dose

Study groups in NCT04487236
Study groupRoleWhat they receive
ZN-A-1041 50mgExperimentalPhase 1a: Subjects will be given ZN-A-1041 orally 50mg Bid, for 21days as one cycle
Receives: Drug: ZN-A-1041 50mg BID
ZN-A-1041 100mgExperimentalPhase 1a: Subjects will be given ZN-A-1041 orally 100mg Bid, for 21days as one cycle
Receives: Drug: ZN-A-1041 100mg BID
ZN-A-1041 200mgExperimentalPhase 1a: Subjects will be given ZN-A-1041 orally 200mg Bid, for 21days as one cycle
Receives: Drug: ZN-A-1041 200mg BID
ZN-A-1041 400mgExperimentalPhase 1a: Subjects will be given ZN-A-1041 orally 400mg Bid, for 21days as one cycle
Receives: Drug: ZN-A-1041 400mg BID
ZN-A-1041 600mgExperimentalPhase 1a: Subjects will be given ZN-A-1041 orally 600mg Bid, for 21days as one cycle
Receives: Drug: ZN-A-1041 600mg BID
ZN-A-1041 800mgExperimentalPhase 1a: Subjects will be given ZN-A-1041 orally 800mg Bid, for 21days as one cycle
Receives: Drug: ZN-A-1041 800mg BID
ZN-A-1041 1000mgExperimentalPhase 1a: Subjects will be given ZN-A-1041 orally 1000mg Bid, for 21days as one cycle
Receives: Drug: ZN-A-1041 1000mg BID
ZN-A-1041 level 1+Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First CycleExperimentalPhase 1b: ZN-A-1041 Level 1 (The previous dose of MTD) to be used in the combination therapy will be determined based on the MTD identified in the Phase 1a study. Capecitabine will be given at the dose of 1000 mg/m2, BID (2000 mg/m2/day), during the first 2 weeks of the 21-day treatment cycle. Trastuzumab (8 mg/kg in cycle 1 followed by 6 mg/kg beginning in cycle 2, administered as an IV infusion. If intolerance, reduce Capecitabine dose to 750 mg/m2 for exploration
Receives: Drug: ZN-A-1041 Level 1 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle
ZN-A-1041 level 2+Capecitabine 1000 mg/m2+ Trastuzumab 8 mg/kg iv. First CycleExperimentalPhase 1b: ZN-A-1041 Level 2 ( dose of MTD) to be used in the combination therapy will be determined based on the MTD identified in the Phase 1a study. Capecitabine will be given at the dose of 1000 mg/m2, BID (2000 mg/m2/day), during the first 2 weeks of the 21-day treatment cycle. Trastuzumab (8 mg/kg in cycle 1 followed by 6 mg/kg beginning in cycle 2, administered as an IV infusion. If intolerance, reduce Capecitabine dose to 750 mg/m2 for exploration
Receives: Drug: ZN-A-1041 Level 2 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle
ZN-A-1041 MAD+Capecitabine 1000 mg/m2+Trastuzumab 8 mg/kg iv. First CycleExperimentalPhase 1b: If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level (MAD) of ZN-A-1041 in Phase 1a will be used in Phase 1b study. If intolerance, reduce Capecitabine dose to 750 mg/m2 for exploration
Receives: Drug: ZN-A-1041 MAD +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle
ZN-A-1041+Capecitabine+TrastuzumabExperimentalPhase 1c: The combined dose of ZN-A-1041 is based on the recommended combined dose in the Phase 1b and the possible changes in the dosage form and the results of the food effect study, which will be decided by the sponsor and the investigator after discussion
Receives: Drug: ZN-A-1041+Capecitabine + Trastuzumab 8 mg/kg iv. First Cycle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety/tolerability of ZN-A-1041 as a monotherapy on Phase 1a

    Dose at which no more than one out of six patient at the same dose level experiences a probable drug-related dose limiting toxicity.

    Measured: 23days

  2. The safety/tolerability of ZN-A-1041 in combination with Capecitabine and Trastuzumab in Phase 1b

    Dose at which no more than one out of six patient at the same dose level experiences a probable drug-related dose limiting toxicity.

    Measured: 21days

  3. The safety of ZN-A-1041 in combination with Capecitabine and Trastuzumab in Phase 1c

    To evaluate the safety of ZN-A-1041 in combination with Capecitabine in patients on the RP2D Dose

    Measured: through study completion, an average of 3 year

Secondary outcomes (4)

  1. Plasma Level of ZN-A-1041 and its major metabolites on phase 1a,phase 1b and 1c

    To assess the AUC of ZN-A-1041 and its major metabolites;

    Measured: From baseline to Day 8

  2. Plasma Level of ZN-A-1041 and its major metabolites on Phase 1a,phase 1 b and 1c

    To assess the Cmax of ZN-A-1041 and its major metabolites;

    Measured: From baseline to Day 8

  3. Plasma level of ZN-A-1041 and its main metabolites Phase 1a,phase 1b and 1c

    To assess the Tmax of ZN-A-1041 and its major metabolites;

    Measured: From baseline to Day 8

  4. The preliminary efficacy of ZN-A-1041 as a monotherapy or combination in Phase 1a,phase 1b and 1c

    overall Response Rate (ORR);Progression free survival(PFS)

    Measured: through study completion, an average of 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start15 Oct 2020
  3. Primary completion16 Apr 2024
  4. Study completion16 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487236
Sponsor's protocol ID
ZN-A-1041-101
Status last verified
Aug 2025
First submitted
10 Jul 2020
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZN-A-1041 50mg BID, ZN-A-1041 100mg BID and ZN-A-1041 200mg BID in people with Advanced Solid Tumors and HER2-positive Breast Cancer, run by Suzhou Zanrong Pharma Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety/tolerability of ZN-A-1041 as a monotherapy on Phase 1a (time frame: 23days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04487236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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