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Advanced Solid TumorPhase 1/2NCT04934514

Clinical Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors

A Phase 1/2 study testing IAH0968, Gemcitabine and Cisplatin in people with Advanced Solid Tumor, run by SUNHO（China）BioPharmaceutical 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of IAH0968 in patients with HER2-positive advanced solid tumors who have failed standard treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
IAH0968, Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteChina
Study dates
6 Jul 2021to 31 Mar 2025
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Phase Ia and Ib: Aged 18 to 65 years old male and female; Phase IIa :Aged 18 to 75 years old male and female
  • Phase I study: Phase Ia and Phase Ib will enroll patients with HER2-positive advanced solid tumors who were confirmed by histopathology and/or cytology and who had failed standard treatments.
  • Phase IIa study: Cohort 1 will enroll patients with HER2-positive advanced biliary system tumors who were confirmed by histopathology and/or cytology and failed standard treatment. Cohort 2 will enroll patients with newly treated HER2-positive advanced biliary system tumors diagnosed by histopathology and/or cytology.
  • According to the RECIST 1.1 standard, at least one measurable lesion exists, and the measurable lesion has not received local treatment (including local radiotherapy, ablation, and interventional therapy).
  • ECOG performance status 0-1.
  • Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥100 g/L, white blood cell count (WBC) ≥3.0×10^9/L, neutrophil count (ANC) ≥1.5×10^9/L, platelet count ( PLT) ≥75×10^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method.
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  • Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography.
  • Life expectancy ≥3 months.
  • Agree to use at least one medically approved contraceptive method during the trial period and at least 6 months after the last dose (female patients: such as intrauterine devices, contraceptives or condoms, etc.; male patients: such as condoms, abstinence, etc.). Female patients must be non-lactating.
  • Subjects must be fully informed of the content, process and possible risks and benefits of the research and sign the informed consent form. Good compliance, able to complete the study and follow-up.

Who cannot join

  • Known to have hypersensitivity to any monoclonal antibody.
  • Not recovered from the adverse reactions caused by previous anti-tumor treatments (refer to CTCAE 5.0 to judge, hematological toxicity ≥ 2 grade, non-hematological toxicity ≥ 1 grade). Long-term toxicity after radiotherapy, which is judged to be irreversible by researchers, such as hair loss and pigmentation are excluded.
  • Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  • Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
  • Received a preventive vaccine or attenuated vaccine or have received blood transfusion within 4 weeks before joining the group.
  • Stage Ia and Stage Ib: Patients who have received trastuzumab and its biosimilar drugs (including single drugs, combination chemotherapy, ADC drugs, bispecific antibodies, etc.) 6 months before enrollment. Stage IIa: Patients who have previously received anti-HER2 therapy.
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  • Have received any systemic anti-tumor therapy within 4 weeks before enrollment.
  • Participated in other clinical trials within 4 weeks before enrollment and used clinical research drugs during this period.
  • Central nervous system metastases with clinical symptoms were found within 4 weeks before enrollment. Patients who have previously received treatment for brain or meningeal metastases, if clinical stability has been maintained for at least 2 months, and have stopped systemic hormone therapy (dose>10 mg/day prednisone or other curative hormones) for more than 4 weeks can be included.
  • Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
  • Past or present suffering from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
  • Suffer from serious or poorly controlled diseases, including but not limited to: ① Myocardial infarction, unstable angina pectoris, clinically significant arrhythmias requiring treatment, congestive heart failure, pericarditis, myocarditis, etc. occurred within 6 months before enrollment. ②Hepatitis B virus (HBV) infection and HBV DNA positive (>1×10^3 copies/mL or >500 IU/mL), hepatitis C virus (HCV) infection and HCV RNA positive (>1×10^3 copies/mL or >100 IU/mL), human immunodeficiency virus (HIV) test positive; ③ poorly controlled diabetes, hypertension, thyroid disease, etc.; ④ severe and uncontrollable lung disease (severe infectious pneumonia, interstitial lung disease) Etc.) (≥CTCAE level 3); ⑤Severe infections that cannot be controlled (≥CTCAE level 3).
  • With any situations that the researcher considers inappropriate to participate in this research.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Yunpeng Liu, MD, 13898865122, cmu_trial@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I/IIa Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors

This is a phase I/IIa study to evaluate the safety, tolerability and preliminary efficacy of IAH0968 in patients with HER2-positive advanced solid tumors who have failed standard treatment.

Read the detailed description

The purpose of the Phase Ia/Ib study is to evaluate the tolerability, safety, PK, immunogenicity and preliminary anti-tumor activity of IAH0968 in Chinese subjects. Phase Ia is a dose escalation, and it is planned to recruit about 10-19 subjects with HER2-positive advanced malignancies who have failed standard treatment. Phase Ib is a dose expansion, and it is planned to recruit approximately 18 subjects with HER2-positive advanced malignancies who have failed standard treatment. Phase IIa mainly investigates the effectiveness and safety of IAH0968 in HER2-positive subjects with advanced biliary system tumors.

Being tested
IAH0968, Gemcitabine, Cisplatin
Keywords
HER2-positive, Advanced Solid Tumor

What participants receive

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

  • IAH0968Biological

    IAH0968 is an investigational product.

  • GemcitabineDrug

    Gemcitabine 1000 mg/m^2 intravenous infusion

  • CisplatinDrug

    Cisplatin 75 mg/m^2 intravenous infusion

Study groups in NCT04934514
Study groupRoleWhat they receive
Ia stage-Dose escalationExperimentalUsing the "3+3" model, 1 subject was included in the 6 mg/kg dose group, and then 3 to 6 patients with HER2-positive advanced solid tumors that failed standard treatment were included in the fixed 3 dose groups (10 mg/kg, 15 mg/kg, and 20 mg/kg) .
Receives: Biological: IAH0968
Ib stage-Dose extensionExperimentalIn the three fixed dose groups (10 mg/kg, 15 mg/kg and 20 mg/kg), when a certain dose group meets the condition of increasing the dose to the higher dose (after the DLT observation period for the last subject in the dose group), the second phase of the dose expansion study for this dose group can be carried out. Each dose group includes 6 patients with HER2-positive advanced solid tumors who have failed the standard treatment, and the interval between enrollment is determined by the investigator.
Receives: Biological: IAH0968
IIa stage-Single-agent study (cohort 1)ExperimentalAfter the completion of the dose escalation in the 20 mg/kg dose group (Phase Ia), a total of 30 patients with HER2-positive advanced biliary system tumors who have failed standard treatment will be enrolled in the 20 mg/kg dose group. Every 3 weeks is a cycle, and the drug is administered once on the first day of each cycle, and the treatment is continued until any end-point event occurs.
Receives: Biological: IAH0968
IIa stage - IAH0968 combined GP regimen study (cohort 2)ExperimentalAfter the completion of the dose escalation in the 20 mg/kg dose group (phase Ia), a total of 30 patients with newly treated HER2-positive advanced biliary system tumors will be enrolled in the 20 mg/kg dose group combined with the GP regimen (gemcitabine + cisplatin) . Every 3 weeks is a cycle, treatment until any end-point event occurs.
Receives: Biological: IAH0968; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. Frequency of adverse events (AEs) and SAEs (Phase Ⅰ)

    To investigate the safety characteristics.

    Measured: 3 months after end event visit

  2. Dose limiting toxicities (DLTs) (Phase Ⅰ)

    To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

    Measured: 21 days after first dose

  3. Objective response rate (ORR) in dose expansion (Phase Ⅱa)

    To explore the clinical effectiveness. Tumor response based on RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

Secondary outcomes (25)

  1. Pharmacokinetic (PK) Cmax (Phase Ⅰ)

    PK parameters (Cmax) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  2. Pharmacokinetic (PK) Cmin (Phase Ⅰ)

    PK parameters (Cmin) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  3. Pharmacokinetic (PK) Tmax (Phase Ⅰ)

    PK parameters (Tmax) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  4. Pharmacokinetic (PK) AUC 0-t (Phase Ⅰ)

    PK parameters (AUC 0-t) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  5. Pharmacokinetic (PK) AUC 0-∞ (Phase Ⅰ)

    PK parameters (AUC 0-∞) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  6. Pharmacokinetic (PK) CL (Phase Ⅰ)

    PK parameters (CL) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  7. Pharmacokinetic (PK) Vd (Phase Ⅰ)

    PK parameters (Vd) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  8. Pharmacokinetic (PK) t1/2 (Phase Ⅰ)

    PK parameters (t1/2) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  9. Pharmacokinetic (PK) λz (Phase Ⅰ)

    PK parameters (λz) following single dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  10. Pharmacokinetic (PK) Css,max (Phase Ⅰ)

    PK parameters (Css,max) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  11. Pharmacokinetic (PK) Css,min (Phase Ⅰ)

    PK parameters (Css,min) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  12. Pharmacokinetic (PK) Css,av (Phase Ⅰ)

    PK parameters (Css,av) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  13. Pharmacokinetic (PK) AUCss (Phase Ⅰ)

    PK parameters (AUCss) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  14. Pharmacokinetic (PK) CLss (Phase Ⅰ)

    PK parameters (CLss) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  15. Pharmacokinetic (PK) Vss (Phase Ⅰ)

    PK parameters (Vss) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  16. Pharmacokinetic (PK) R (Phase Ⅰ)

    PK parameters (R) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  17. Pharmacokinetic (PK) DF (Phase Ⅰ)

    PK parameters (DF) following multiple dose.

    Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

  18. Objective response rate (ORR) in dose escalation (Phase Ⅰ)

    Tumor response based on RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

  19. Incidence of adverse events (AEs) and SAEs (Phase Ⅰ)

    To investigate the safety characteristics.

    Measured: 3 months after end event visit

  20. Immunogenicity of IAH0968 (Phase Ⅰ)

    The frequency of anti-drug antibodies (ADA) against IAH0968.(Phase Ⅰ)

    Measured: 3 months after end event visit

  21. Progression free survival (PFS) (Phase Ⅱa)

    PFS as assessed using RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

  22. Overall survival (OS) (Phase Ⅱa)

    OS as assessed using RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

  23. Disease control rate (DCR) (Phase Ⅱa)

    DCR as assessed using RECIST 1.1.

    Measured: Baseline through up to 2 years or until disease progression

  24. Incidence of adverse events (AEs) and SAEs (Phase Ⅱa)

    To investigate the safety characteristics.

    Measured: 3 months after end event visit

  25. Immunogenicity of IAH0968 (Phase Ⅱa)

    The frequency of anti-drug antibodies (ADA) against IAH0968.(Phase Ⅱa)

    Measured: 3 months after end event visit

Timeline

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

  1. First posted22 Jun 2021
  2. Study start6 Jul 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Mar 2025 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
97 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04934514
Sponsor's protocol ID
IAH0968-I/IIa
Status last verified
Mar 2023
First submitted
7 Jun 2021
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Song N, Teng Y, Shi J, Teng Z, Jin B, Qu J, Zhang L, Yu P, Zhao L, Wang J, Li A, Tong L, Jiang S, Liu Y, Yin L, Jiang X, Xu T, Cui J, Qu X, Liu Y. A novel anti-HER2 monoclonal antibody IAH0968 in HER2-positive heavily pretreated solid tumors: results from a phase Ia/Ib first-in-human, open-label, single center study. Front Immunol. 2024 Nov 29;15:1481326. doi: 10.3389/fimmu.2024.1481326. eCollection 2024.

    PubMed 39676868

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IAH0968, Gemcitabine and Cisplatin in people with Advanced Solid Tumor, run by SUNHO（China）BioPharmaceutical 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 13 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 20 Feb 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (AEs) and SAEs (Phase Ⅰ) (time frame: 3 months after end event visit). 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 NCT04934514, which also lists 1 linked publication.

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 20 Feb 2024.

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