HER2 Gene MutationPhase 1/2NCT05991518

IAH0968 in Combination With GC for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors

A Phase 1/2 study testing Injection of IAH0968+Gemcitabine+Cisplatin and Gemcitabine+Cisplatin in people with HER2 Gene Mutation, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 18 years and older
Conditions the study is for: HER2 Gene Mutation
What is being tested?: Injection of IAH0968+Gemcitabine+Cisplatin and Gemcitabine+Cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteChina
Study dates: 25 Apr 2023to Dec 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Phase Ib
The age of the participant should be 18 years or older.
The participant should have been diagnosed with HER2-positive advanced solid tumors that have failed standard treatment, as confirmed by pathological histology or cytology. Standard treatment failure is defined as disease progression during or after the last treatment, or inability to tolerate treatment due to severe toxicity (grade ≥ 4 hematologic toxicity or grade ≥ 3 non-hematologic toxicity following previous standard treatment). HER2 positivity is defined as proven HER2-positive through immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH). The interpretation and standards for HER2 positivity in breast cancer will follow current breast cancer guidelines, and for HER2 positivity in cancers other than breast cancer, current gastric cancer guidelines will be followed (Appendix 9).
The GC regimen is the frontline standard treatment for the specific type of cancer (including urinary tract carcinoma, NSCLC, pancreatic cancer, nasopharyngeal carcinoma, etc.).
The participant should have at least one measurable lesion according to RECIST 1.1 criteria, and the measurable lesion should not have undergone any local treatment (including local radiotherapy, ablation, and intervention therapy).
The ECOG performance status should be 0 or 1 (refer to Appendix 3).

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During the screening phase, the participant's organ functions should be relatively normal (upper limit of normal values based on the respective study center's range), including:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Hemoglobin (Hgb) ≥ 90 g/L
Platelet count (PLT) ≥ 90 × 109/L
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × upper limit of normal (ULN), or ≤ 5.0 × ULN for patients with liver metastasis
Total bilirubin (TBIL) ≤ 1.5 × ULN
Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min calculated according to the Cockcroft-Gault formula (refer to Appendix 2)
All premenopausal women and women within 12 months of menopause should have a negative pregnancy test.
Left ventricular ejection fraction (LVEF) ≥ 50%.
Prothrombin time or international normalized ratio ≤ 1.5 × ULN, unless the patient is receiving anticoagulant therapy.
If the patient has received platelet growth factors and/or granulocyte colony-stimulating factors prior to the above examinations, a washout period of at least 1 week is required.
The expected survival period should be ≥ 3 months.
The patient should agree to use at least one medically acceptable contraceptive method during the study treatment period and within 6 months following the end of the study treatment (for women: intrauterine device, oral contraceptives, or condoms, etc.; for men: condoms, abstinence, etc.), and female patients should not be lactating.
The patient should have full understanding of the study content, procedures, and potential risks and benefits, and should sign the informed consent form. The patient should demonstrate good compliance and be able to cooperate with the study and follow-up.
Phase IIa
The age of the participant should be 18 years or older.
The participant should have been diagnosed with locally advanced or metastatic HER2-positive BTC (biliary tract cancer) confirmed by pathological histology or cytology, and should not have received systemic chemotherapy treatment.
The participant should have at least one measurable lesion according to RECIST 1.1 criteria, and the measurable lesion should not have undergone any local treatment (including local radiotherapy, ablation, and intervention therapy).
The ECOG performance status should be 0 or 1 (refer to Appendix 3).
During the screening phase, the participant's organ functions should be relatively normal (upper limit of normal values based on the respective study center's range), including:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Hemoglobin (Hgb) ≥ 90 g/L
Platelet count (PLT) ≥ 90 × 109/L
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × upper limit of normal (ULN), or ≤ 5.0 × ULN for patients with liver metastasis
Total bilirubin (TBIL) ≤ 1.5 × ULN
Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min calculated according to the Cockcroft-Gault formula (refer to Appendix 2)
All premenopausal women and women within 12 months of menopause should have a negative pregnancy test.
Left ventricular ejection fraction (LVEF) ≥ 50%.
Prothrombin time or international normalized ratio ≤ 1.5 × ULN, unless the patient is receiving anticoagulant therapy.
The expected survival period should be ≥ 3 months.
The patient should agree to use at least one medically acceptable contraceptive method during the study treatment period and within 6 months following the end of the study treatment (for women: intrauterine device, oral contraceptives, condoms, etc.; for men: condoms, abstinence, etc.), and female patients should not be lactating.
The patient should have full understanding of the study content, procedures, and potential risks and benefits, and should sign the informed consent form. The patient should demonstrate good compliance and be able to cooperate with the study and follow-up.

Who cannot join

Phase Ib
Known hypersensitivity reaction to any monoclonal antibody or a documented history of allergies to gemcitabine or cisplatin and its components.
Previous treatment: (1) Not recovered from adverse reactions caused by previous anti-tumor treatment to normal levels (according to CTCAE 5.0, hematologic toxicity ≥ Grade 2, non-hematologic toxicity ≥ Grade 1), excluding radiation-induced late toxicities considered irreversible by the investigator such as alopecia and skin pigmentation. (2) Patients who have received treatment with trastuzumab/pertuzumab and their biosimilars (mono-therapy, combination chemotherapy, ADC drugs, bispecific antibodies, etc.) within 4 weeks prior to enrollment. (3) Patients who have participated in other clinical trials within 4 weeks prior to enrollment and have used investigational drugs during this period. (4) Patients who have previously received GC regimen treatment for anti-tumor therapy and experienced relapse due to drug resistance.
Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Surgical procedures within 4 weeks prior to enrollment, and the investigator considers that the patient's condition has not recovered to a level allowing for initiation of this study treatment (excluding previous diagnostic biopsies and biliary stent placement/percutaneous transhepatic cholangiographic drainage procedures performed to relieve bile duct obstruction [PTBD]).
Vaccination with live vaccines within 4 weeks prior to enrollment, or receipt of blood transfusion within 2 weeks.

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Radiotherapy other than focal palliative bone radiotherapy within 4 weeks prior to enrollment.
Clinical symptoms of central nervous system metastasis within 4 weeks prior to enrollment. Patients with previous treatment for brain or meningeal metastases may be included if the clinical condition is stable for at least 2 months and systemic steroid therapy (dose > 10 mg/day prednisone or equivalent) has been discontinued for ≥ 4 weeks.
Hospitalization or inability to undergo study treatment within 30 days prior to randomization due to exacerbation of chronic obstructive pulmonary disease or other respiratory diseases.
Liver transplant candidates and patients who can undergo transplantation during a medically acceptable period.
Exclusion of early-stage cancers (other than those treated with curative intent within 5 years before signing the informed consent), including but not limited to in situ cervical cancer, superficial noninvasive bladder cancer, basal cell carcinoma, and in situ squamous cell carcinoma, or gastrointestinal tumors limited to the mucosal layer and already resected under endoscopy.
Presence of severe or poorly controlled diseases, including but not limited to: (1) myocardial infarction, clinically significant arrhythmias requiring treatment, congestive heart failure, myocarditis, and angina pectoris occurring within 6 months prior to enrollment. (2) Hepatitis B virus (HBV) infection with positive HBV DNA (≥1.0×104 copies/mL or ≥2000 IU/mL), hepatitis C virus (HCV) infection with positive HCV RNA (>1.0×103 copies/mL or >100 IU/mL), and positive human immunodeficiency virus (HIV) test. (3) Active tuberculosis (clinical symptoms, physical examination findings, or radiographic evidence of active tuberculosis). (4) Severe and uncontrolled pulmonary diseases (severe infectious pneumonia, interstitial lung disease, etc.) (≥ Grade 3 CTCAE). (5) Uncontrolled biliary infection. Biliary obstruction should be relieved by endoscopic or percutaneous transhepatic biliary drainage (PTBD). Patients with biliary obstruction should have sufficient biliary drainage and no evidence of ongoing infection at the time of enrollment and on Day 1 of Cycle 1 without antibiotic treatment. (6) Severe infections of any type that are uncontrolled (≥ Grade 3 CTCAE). (7) Presence of ascites, pleural effusion, or pericardial effusion requiring drainage before the first study drug treatment.
Presence of other conditions considered inappropriate for participation in this study by the investigator.
Phase IIa
Known hypersensitivity reaction to any monoclonal antibody.
History of allergy to gemcitabine or cisplatin and its components.
Recent surgery within 4 weeks prior to enrollment, with the patient's condition considered inadequate for starting the study treatment (excluding prior diagnostic biopsies and percutaneous transhepatic biliary drainage PTBD for relieving bile duct obstruction).
Vaccination with any live vaccines within 4 weeks prior to enrollment or receipt of blood transfusion within 2 weeks.
Radiation therapy received within 4 weeks prior to enrollment, excluding focal palliative bone radiation.
Detection of clinically symptomatic central nervous system metastasis within 4 weeks prior to enrollment. Prior treatment for brain or meningeal metastasis is allowed if clinically stable for at least 2 months and has stopped systemic steroid therapy (dose >10 mg/day prednisone or equivalent) for ≥4 weeks.
Hospitalization or inability to initiate study treatment due to exacerbation of chronic obstructive pulmonary disease or other respiratory diseases within 30 days prior to randomization.
Liver transplant candidates and patients who are eligible for transplantation within a medically acceptable time frame.
Exclusion of early-stage cancers treated with curative intent within the past 5 years or mucosal cancers limited to gastroenteric mucosa and treated by endoscopic resection.
Presence of severe or poorly controlled diseases, including but not limited to: a) occurrence of myocardial infarction, clinically significant cardiac arrhythmias requiring treatment, congestive heart failure, myocarditis, or angina within 6 months prior to enrollment; b) Hepatitis B virus (HBV) infection with positive HBV DNA (≥1.0×104 copies/mL or ≥2000 IU/mL), hepatitis C virus (HCV) infection with positive HCV RNA (>1.0×103 copies/mL or >100 IU/mL), or positive human immunodeficiency virus (HIV) test; c) active tuberculosis (clinical symptoms, physical examination findings, or radiographic evidence of active tuberculosis); d) severe and uncontrolled pulmonary disease (severe infectious pneumonia, interstitial lung disease, etc.) (≥CTCAE Grade 3); e) uncontrolled biliary infection. Biliary obstruction should be relieved by stent placement or percutaneous transhepatic biliary drainage (PTBD). Patients with biliary obstruction should have adequate biliary drainage, with no evidence of ongoing infection on the day of enrollment and Day 1 of Cycle 1, without receiving antibiotic treatment; f) uncontrolled severe infections of any kind (≥CTCAE Grade 3); and g) presence of ascites, pleural effusion, or pericardial effusion requiring drainage prior to initial study drug treatment.
Other conditions deemed inappropriate for participation in this study, as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

cao jianxiang, M.D. contact

18018039840

caojianxiang@sunho-bio.com

China1 site, 1 recruiting

Fudan University Affiliated Zhongshan Hospital
Shanghai
Liu Tianshu, M.D.
Recruiting

Other trials in China

About this study

Official title: Phase Ib/II Clinical Study of IAH0968 in Combination With Gemcitabine and Cisplatin for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors and Cholangiocarcinoma

The study aims to evaluate the efficacy and safety of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma. The study is divided into two stages: Phase Ib, an open-label, non-randomized, multicenter dose-escalation trial, and Phase II, a randomized, double-blind, parallel-controlled, multicenter trial.

Read the detailed description

Phase Ib is an open-label, non-randomized, multicenter dose-escalation trial. It utilizes the classic "3+3" design to investigate the safety and tolerability of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma.

Phase II study is a randomized, double-blind, parallel-controlled, multicenter research design. It aims to investigate the efficacy of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma.

Conditions: HER2 Gene Mutation
Being tested: Injection of IAH0968+Gemcitabine+Cisplatin, Gemcitabine+Cisplatin

What participants receive

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

Injection of IAH0968+Gemcitabine+CisplatinCombination product
Also called IAH0968+GC
Administration of IAH0968 is given once per cycle, with each cycle defined as every 3 weeks.
Gemcitabine+CisplatinCombination product
Also called GC
Gemcitabine is administered at a dose of 1000 mg/m2 on the second day (D2) and ninth day (D9) of each cycle. At least 6 hours after the completion of gemcitabine infusion, cisplatin is administered at a dose of 70 mg/m2 on the second day (D2) of each cycle.

Study groups in NCT05991518
Study group	Role	What they receive
Phase Ia - Dose escalation	Experimental	To determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and/or recommended phase II dose (RP2D) of intravenous IAH0968 in combination with the GC regimen for adult patients with HER2-positive advanced solid tumors who have failed standard treatment. Receives: Combination Product: Injection of IAH0968+Gemcitabine+Cisplatin
Phase IIa - Clinical Exploratory Stage	Experimental	The RP2D determined from the Phase Ib study is used as the first-line treatment for HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have not received prior systemic therapy. The efficacy of IAH0968 in combination with the GC regimen is compared to the efficacy of placebo in combination with the GC regimen based on the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, using the objective remission rate (ORR) as the evaluation criteria. Receives: Combination Product: Injection of IAH0968+Gemcitabine+Cisplatin; Combination Product: Gemcitabine+Cisplatin

What is being measured

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

Frequency of adverse events (AEs) and SAEs (Phase Ⅰ)
To investigate the safety characteristics.
Measured: 3 months after end event visit
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
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 1 years or until disease progression

Secondary outcomes (25)

Pharmacokinetic (PK) Cmax (Phase Ⅰ)
PK parameters (Cmax) following single dose.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
Pharmacokinetic (PK) Cmin (Phase Ⅰ)
PK parameters (Cmin) following single dose.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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Objective response rate (ORR) in dose escalation (Phase Ⅰ)
Tumor response based on RECIST 1.1.
Measured: Baseline through up to 1 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅰ)
To investigate the safety characteristics.
Measured: 3 months after end event visit
Immunogenicity of IAH0968 (Phase Ⅰ)
The frequency of anti-drug antibodies (ADA) against IAH0968.(Phase Ⅰb)
Measured: 3 months after end event visit
Progression free survival (PFS) (Phase Ⅱa)
PFS as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase Ⅱa)
OS as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Disease control rate (DCR) (Phase Ⅱa)
DCR as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅱa)
To investigate the safety characteristics.
Measured: 3 months after end event visit
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.

25 Apr 2023Dec 2025

First posted14 Aug 2023
Study start25 Apr 2023
Primary completionDec 2024 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HER2 Gene MutationStudies of the same condition, open and under way.
More trials run by SUNHO（China）BioPharmaceutical CO., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 136 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05991518
Sponsor's protocol ID: IAH0968-201
Status last verified: Feb 2024
First submitted: 26 Jul 2023
Last updated: 20 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ib/II Clinical Study of IAH0968 in Combination With Gemcitabine and Cisplatin for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors and Cholangiocarcinoma
ClinicalTrials.gov ID: NCT05991518
Acronym / sponsor ID: IAH0968-201
Conditions: HER2 Gene Mutation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 136 participants (estimated)
Lead sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Apr 2023 (actual)
Primary completion: Dec 2024 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 14 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Phase Ia - Dose escalation	Experimental	Combination Product: Injection of IAH0968+Gemcitabine+CisplatinTo determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and/or recommended phase II dose (RP2D) of intravenous IAH0968 in combination with the GC regimen for adult patients with HER2-positive advanced solid tumors who have failed standard treatment.
Phase IIa - Clinical Exploratory Stage	Experimental	Combination Product: Injection of IAH0968+Gemcitabine+Cisplatin, Combination Product: Gemcitabine+CisplatinThe RP2D determined from the Phase Ib study is used as the first-line treatment for HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have not received prior systemic therapy. The efficacy of IAH0968 in combination with the GC regimen is compared to the efficacy of placebo in combination with the GC regimen based on the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, using the objective remission rate (ORR) as the evaluation criteria.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (38 listed)

Phase Ib
The age of the participant should be 18 years or older.
The participant should have been diagnosed with HER2-positive advanced solid tumors that have failed standard treatment, as confirmed by pathological histology or cytology. Standard treatment failure is defined as disease progression during or after the last treatment, or inability to tolerate treatment due to severe toxicity (grade ≥ 4 hematologic toxicity or grade ≥ 3 non-hematologic toxicity following previous standard treatment). HER2 positivity is defined as proven HER2-positive through immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH). The interpretation and standards for HER2 positivity in breast cancer will follow current breast cancer guidelines, and for HER2 positivity in cancers other than breast cancer, current gastric cancer guidelines will be followed (Appendix 9).
The GC regimen is the frontline standard treatment for the specific type of cancer (including urinary tract carcinoma, NSCLC, pancreatic cancer, nasopharyngeal carcinoma, etc.).
The participant should have at least one measurable lesion according to RECIST 1.1 criteria, and the measurable lesion should not have undergone any local treatment (including local radiotherapy, ablation, and intervention therapy).

Key exclusion criteria (25 listed)

Phase Ib
Known hypersensitivity reaction to any monoclonal antibody or a documented history of allergies to gemcitabine or cisplatin and its components.
Previous treatment: (1) Not recovered from adverse reactions caused by previous anti-tumor treatment to normal levels (according to CTCAE 5.0, hematologic toxicity ≥ Grade 2, non-hematologic toxicity ≥ Grade 1), excluding radiation-induced late toxicities considered irreversible by the investigator such as alopecia and skin pigmentation. (2) Patients who have received treatment with trastuzumab/pertuzumab and their biosimilars (mono-therapy, combination chemotherapy, ADC drugs, bispecific antibodies, etc.) within 4 weeks prior to enrollment. (3) Patients who have participated in other clinical trials within 4 weeks prior to enrollment and have used investigational drugs during this period. (4) Patients who have previously received GC regimen treatment for anti-tumor therapy and experienced relapse due to drug resistance.
Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Surgical procedures within 4 weeks prior to enrollment, and the investigator considers that the patient's condition has not recovered to a level allowing for initiation of this study treatment (excluding previous diagnostic biopsies and biliary stent placement/percutaneous transhepatic cholangiographic drainage procedures performed to relieve bile duct obstruction [PTBD]).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Injection of IAH0968+Gemcitabine+CisplatinAlso: IAH0968+GCAdministration of IAH0968 is given once per cycle, with each cycle defined as every 3 weeks.	Combination product	Phase IIa - Clinical Exploratory Stage, Phase Ia - Dose escalation
Gemcitabine+CisplatinAlso: GCGemcitabine is administered at a dose of 1000 mg/m2 on the second day (D2) and ninth day (D9) of each cycle. At least 6 hours after the completion of gemcitabine infusion, cisplatin is administered at a dose of 70 mg/m2 on the second day (D2) of each cycle.	Combination product	Phase IIa - Clinical Exploratory Stage

Primary outcome

Frequency of adverse events (AEs) and SAEs (Phase Ⅰ)
Time frame: 3 months after end event visit
To investigate the safety characteristics.
Dose limiting toxicities (DLTs) (Phase Ⅰ)
Time frame: 21 days after first dose
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Objective response rate (ORR) in dose expansion (Phase Ⅱa)
Time frame: Baseline through up to 1 years or until disease progression
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.

25 secondary outcomes

Pharmacokinetic (PK) Cmax (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) Cmin (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) Tmax (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) AUC 0-t (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) AUC 0-∞ (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) CL (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) Vd (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) t1/2 (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) λz (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) Css,max (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) Css,min (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) Css,av (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) AUCss (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) CLss (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) Vss (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) R (Phase Ⅰ)
Time frame: 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
Pharmacokinetic (PK) DF (Phase Ⅰ)
Time frame: 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
Objective response rate (ORR) in dose escalation (Phase Ⅰ)
Time frame: Baseline through up to 1 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅰ)
Time frame: 3 months after end event visit
Immunogenicity of IAH0968 (Phase Ⅰ)
Time frame: 3 months after end event visit
Progression free survival (PFS) (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
Disease control rate (DCR) (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅱa)
Time frame: 3 months after end event visit
Immunogenicity of IAH0968 (Phase Ⅱa)
Time frame: 3 months after end event visit

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

cao jianxiang, M.D. contact

18018039840

caojianxiang@sunho-bio.com

Zhou Jian, M.D. principal investigator

Fudan University

Liu Tianshu, M.D. principal investigator

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 38 inclusion and 25 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?

Contact cao jianxiang, M.D. (18018039840, caojianxiang@sunho-bio.com), or a site near the patient. 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 NCT05991518.

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.