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Advanced Solid TumorPhase 1NCT05877664

Study of ZG0895.HCl in Patients With Advanced Solid Tumors

A Phase 1 study testing ZG0895 Hydrochloride for Injection in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of ZG0895.HCl. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ZG0895 Hydrochloride for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
8 Aug 2023to Jun 2026
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully understand the study and voluntarily sign the informed consent form(ICF).
  • Age ≥ 18 and ≤ 75 years old at the time of signing the ICF, either male or female;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Life expectancy ≥ 3 months.
  • All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1(except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc).
  • Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.
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  • For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.
  • Part 1:
  • Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1).
  • Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom available standard treatments failed or were intolerable.

Who cannot join

  • Participants receiving any of the following treatments:
  • Previously treated with systemic TLR7/8 immunomodulators.
  • Any other investigational product treatment within 4 weeks before the first dosing.
  • Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines within 4 weeks before the first dosing. Local palliative radiotherapy, traditional Chinese medicine with anti-tumor effect, and small molecule targeted therapy within 2 weeks (or 5 half-lives, whichever is longer) before the first dosing.
  • Major surgery within 4 weeks before the first dosing for any reason (excluding puncture biopsy), or need to undergo elective surgery during the trial.
  • Potent CYP3A4/5 inducer or inhibitor within 2 weeks prior to administration of the first dose of the study drug.
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  • Systemic immunosuppressive drugs within 2 weeks prior to administration of the first dose of the study drug, including systemic corticosteroids (>10 mg/day prednisone or equivalent).
  • Other immunomodulators within 2 weeks prior to administration of the first dose of the study drug, including but not limited to thymosin, interleukin-2 and interferon.
  • Had CTCAE Grade ≥3 immune-related adverse events (irAE) after receiving immunotherapy.
  • The main organ function meets any of the following criteria within 7 days prior to the first dosing. （Note: blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy are not allowed within 14 days prior to treatment.)
  • Hematological function: ANC < 1.5×10^9/L, PLT < 75×10^9/L, Hemoglobin (Hb) < 100 g/L.
  • Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN; ALT and AST ≥ 5×ULN for participants with liver metastases; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30 g/L.
  • Creatinine clearance< 75 mL/min.
  • INR > 1.5 or APTT > 1.5×ULN.
  • The urine protein presents positive and the quantitative result of 24-h urine protein ≥ 1 g.
  • Participants with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence suggesting that the central nervous system metastasis or meningeal metastasis is not well-controlled and is judged by the investigator to be unsuitable for enrollment.
  • Uncontrollable third cavity effusion (e.g. large amount pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which is judged by the investigator to be unsuitable for enrollment.
  • Known history of neurological disorders affecting brain functional activities, including epilepsy or dementia.
  • Severe cardiac-cerebral vascular disease, including but not limited to:
  • Acute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before the first dosing.
  • New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% or the lower normal limit.
  • Uncontrollable hypertension (even though the best available treatment is used but systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
  • QTcF interval prolongation during the baseline period.
  • Participants with active or history of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid diseases.
  • Active infection requiring systemic therapy within 7 days prior to the first dosing; active hepatitis B or hepatitis C, history of immunodeficiency virus (HIV) disease or HIV antibody positive.
  • Priorly received allogeneic stem cell transplantation or solid organ transplantation.
  • Known allergy to the ZG0895.HCl or any of its excipients; have severe allergy history (CTCAE Grade ≥ 3), such as severe urticaria, angioedema, severe anaphylaxis, etc.
  • Females who are pregnant or nursing during the screening period.
  • The investigators consider that the participants are not suitable to participate in the clinical study for other reasons.

Trial locations and contacts

1 site in 1 country.

Wenhao Cai contact

+8615918725852

caiwh@zelgen.com

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Zhejiang, Hangzhou, 310022

    Ji Zhu

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Dose Escalation and Expansion, Tolerability, Safety, Pharmacokinetics / Pharmacodynamics and Preliminary Efficacy Study of ZG0895.HCl in Patients With Advanced Solid Tumors

The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of ZG0895.HCl.

Being tested
ZG0895 Hydrochloride for Injection

What participants receive

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

  • ZG0895 Hydrochloride for InjectionDrug

    Also called ZG0895.HCl

    The dose escalation of ZG0895.HCl is set as 0.06, 0.12, 0.18, 0.37, 0.75, 1.50, 2.25, 3.00, and 3.75 mg/m^2 groups, subcutaneous (SC) injection once a week (QW)

Study groups in NCT05877664
Study groupRoleWhat they receive
Part1：Dose EscalationExperimentalDuring the dose-escalation stage, an accelerated titration design (ATD) will be utilized for the first three lower dose groups (0.06, 0.12 and 0.18 mg/m^2). The conventional "3+3" dose escalation method will be used for the subsequent dose groups. The entire duration of 21 days after the first dose of ZG0895.HCl is defined as the dose-limiting toxicity (DLT) observation period.
Receives: Drug: ZG0895 Hydrochloride for Injection

What is being measured

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

  1. The incidence of dose-limiting toxicity (DLT)

    DLT is defined as any of the following adverse events (AE) occurring from the first dose of Day 1 to Day 21, unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause. Delayed DLTs are adverse events that meet the criteria of DLTs that occur after Cycle 1. All AEs will be graded according to the US National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0), except for cytokine release syndrome (CRS)

    Measured: Up to Day 21

  2. The maximum tolerated dose (MTD) of ZG0895.HCl

    During the dose-escalation stage, if there is a first occurrence that ≥ 2 participants in a dose group experience DLT, then the dose level will be considered to be an intolerable dose, and the previous lower dose will be considered to be the MTD. The MTD group should have at least 6 evaluable participants.

    Measured: Up to Day 21

  3. Number of Participants Experiencing Adverse Events (AEs)

    Measured: Up to 3 Years

  4. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Up to 3 Years

Secondary outcomes (1)

  1. Overall Response Rate (ORR) as assessed by the investigator

    Measured: Up to 3 Years

Timeline

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

  1. First posted26 May 2023
  2. Study start8 Aug 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877664
Sponsor's protocol ID
ZG0895-001
Status last verified
Mar 2024
First submitted
11 May 2023
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZG0895 Hydrochloride for Injection in people with Advanced Solid Tumor, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd 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 10 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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?

Results are not available in the source record.

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

Contact Wenhao Cai (+8615918725852, caiwh@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of dose-limiting toxicity (DLT) (time frame: Up to Day 21). The study lists 4 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 NCT05877664.

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 6 Mar 2024.

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