Advanced Malignant NeoplasmPhase 1/2NCT06581419
A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
A Phase 1/2 study testing IAP0971 in people with Advanced Malignant Neoplasm and Advanced or Metastatic Non-small Cell Lung Cancer, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 1 site in China.
Trial summary
Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors. Phase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Neoplasm, Advanced or Metastatic Non-small Cell Lung Cancer
- What is being tested?
- IAP0971
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 1 Aug 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age of 18-75 years old (including cut-off value), regardless of gender.
- Phase I only: patients with histologically confirmed advanced or metastatic malignant solid tumors who have failed to respond to standard treatment, who have no standard treatment options, who are not currently applicable to standard treatment, or who have been assessed by the investigator to benefit from this treatment.
- Phase II only: patients with histologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and definitive concurrent chemoradiotherapy. Note: For patients with locally advanced stage (stage IIIB/IIIC) who cannot accept radical concurrent/sequential chemoradiotherapy, they need to be evaluated by relevant professional physicians and confirmed by written records.
- Phase II only: no prior systemic antitumor therapy for locally advanced or metastatic NSCLC (except for patients who received adjuvant/neoadjuvant chemotherapy or definitive concurrent or sequential chemoradiotherapy for locally advanced disease and disease progression ≥6 months after the last treatment).
- Phase II only: PD-L1 positive (TPS≥50%) as determined by IHC, and patients were negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) by immunohistochemistry.
- have at least one measurable lesion according to RECIST 1.1 criteria (tumor lesion located in the previous radiotherapy area or other locoregional treatment site, generally not considered a measurable lesion unless the lesion has clearly progressed or persists beyond three months of radiotherapy).
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- predicted survival time ≥3 months.
- with adequate organ function:
- ① Blood system (no blood transfusion or hematopoietic stimulation therapy within 14 days) : absolute neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥100×109/L, hemoglobin (HGB) ≥90 g/L; ② Liver function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), except Gilbert's syndrome Out of; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, and patients with liver metastasis or liver cancer need AST and ALT≤5.0 times ULN and total bilirubin ≤3.0 times ULN;
- ② Renal function: serum creatinine (Cr) ≤1.5 times ULN; If creatinine > 1.5 times ULN, creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula) was required.
- ③ Coagulation function: prothrombin international normalized ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN, patients with liver metastasis or liver cancer need INR and APTT≤2.5 times ULN.
- Eligible patients (men and women) of childbearing potential must consent to use a reliable method of contraception (hormonal or barrier methods or abstinence) with their partner during the trial and for at least 6 months after the last dose; Female patients of reproductive age had to have a negative blood pregnancy test within 7 days before the first use of the study drug.
- Subjects must give informed consent for this study and voluntarily provide written informed consent before the trial.
Who cannot join
- Phase II only: small cell lung cancer or sarcomatoid lesion confirmed by histopathology.
- Phase II only: previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 /PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action.
- Phase I only: patients received anti-tumor therapy such as systemic chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of study drug; The following drugs were excluded according to the following criteria:
- ① Treatment with a small-molecule tyrosine kinase inhibitor within 2 weeks before the first dose;
- ② Palliative local treatment for non-target lesions within 2 weeks before the first dose; Patients received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, not including IL-11) within 2 weeks before the first dose;
- ③ received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose.
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- received other investigational drugs or treatments within 4 weeks before the study drug.
- received systemic glucocorticoids (prednisone > 10 mg/ day or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug; The use of topical, ocular, intra-articular, nasal, and inhaled glucocorticoids was excluded. Short-term prophylaxis with glucocorticoids (e.g., to prevent contrast allergy).
- the adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 or the relevant requirements of the inclusion criteria (except for toxicities without safety risks judged by the investigators, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy).
- major surgical procedures (excluding needle biopsies) within 4 weeks before the first dose of study drug, major trauma, or the need for elective surgery during the trial.
- prior allogeneic hematopoietic stem-cell transplantation or organ transplantation.
- clinically symptomatic parenchymal or meningeal metastases.
- have active infection and currently require intravenous anti-infective therapy.
- have a history of immunodeficiency, including testing positive for human immunodeficiency virus (HIV) antibodies.
- active hepatitis B (HBsAg positive and HBV-DNA positive or greater than the upper limit of normal), active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive or greater than the upper limit of normal).
- received any live vaccine within 4 weeks before the first dose of study drug.
- known hypersensitivity to any antibody-based drug (NCI CTCAE grade 5.0 ≥3) or to the study drug, active ingredient, or inactive excipients of a PD-1/PD-L1 inhibitor.
- with severe and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease, etc.); Or other moderate-to-severe lung diseases that severely affect respiratory function that may interfere with the detection or management of drug-related pulmonary toxicity.
- have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:
- ① Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.
- ② Mean QT interval corrected with Fridericia's method (QTcF) > 470 ms;
- ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first dose; ④ patients with New York Heart Association (NYHA) functional class ≥II heart failure or left ventricular ejection fraction (LVEF) < 50% or structural heart disease with high risk as judged by other investigators; And 5) clinically uncontrolled hypertension.
- have an active or previous autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with the possibility of recurrence, except clinically stable autoimmune thyroid disease, type I diabetes mellitus, vitiligo, cured atopic dermatitis in children, and psoriasis (within the past 2 years) that does not require systemic treatment."
- had other malignancies within 5 years before study administration, except for malignancies that could be expected to be cured with treatment (including, but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery).
- have clinically uncontrollable effusion in the third space, which was judged by the investigator to be not suitable for enrollment.
- known alcohol or drug dependence.
- with mental disorders or poor adherence.
- pregnant or lactating women.
- The participant was deemed by the investigator to have a history of other serious systemic diseases or to be ineligible for the study for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 10021
YuanKai Shi, doctor, 8610-87788495, cancergcp@163.com
About this study
Official title: A Phase I/II Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors
Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors.
Phase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer.
Read the detailed description
The study includes dose-escalation (Phase I) and dose-expansion (Phase II) clinical trials. Phase I clinical trials will be conducted first. After completing the dose-escalation phase, the plan is to determine the recommended Phase II dose (RP2D) in the maximum tolerated dose (MTD) group and proceed with the subsequent Phase II exploratory studies.
The objective of the Phase I dose-escalation phase is to preliminarily assess the safety and tolerability of IAP0971 and to determine the MTD based on the incidence of dose-limiting toxicities (DLTs) in each dose group. Phase II will use an open-label, non-randomized, single-arm, multicenter design. The study will evaluate adverse events and adverse reactions through clinical observation, vital sign monitoring, and laboratory tests. Tumor assessments will be conducted using RECIST 1.1 criteria: within 48 weeks of the first infusion of the investigational drug, assessments will be performed after every two cycles (±7 days), and after 48 weeks, assessments will occur every four cycles (±7 days) until disease progression, initiation of new anti-tumor therapy, investigator-determined ineligibility (e.g., intolerable adverse reactions), loss to follow-up, voluntary withdrawal, death, or study termination/suspension.
- Being tested
- IAP0971
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAP0971Drug
Subjects receive IAP0971, which will be administered every 3 weeks in a 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| phase I | Experimental | Dose escalation (Phase I): 14 to 48 subjects with advanced malignancies are planned to be enrolled to initially investigate the safety and tolerability of IAP0971 and to determine the MTD based on the frequency of DLT in each dose arm.The starting dose of IAP0971 for injection is 0.0005 mg/kg, with a preset maximum escalation dose of 18.0 mg/kg, administered once every 3 weeks. Receives: Drug: IAP0971 |
| phase II | Experimental | Dose Extension (Phase II) : Phase II will use an open-label, non-randomized, single-arm, multicenter design. Under the RP2D dose determined in Phase I, 20-30 untreated patients with advanced or metastatic non-small cell lung cancer, who are driver gene negative and PD-L1 positive (TPS ≥ 50%), will be enrolled. The drug IAP0971 is administered once every 3 weeks, and every 3 weeks is 1 cycle Receives: Drug: IAP0971 |
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.progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data.
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
PFS in dose expansion (Phase II)
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 (23)
pharmacokinetic parameters Cmax (Phase I)
Cmax after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Tmax (Phase I)
Tmax after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters AUC 0-t (Phase I)
AUC 0-t after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters AUC 0-∞ (Phase I)
AUC 0-∞ after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters CL (Phase I)
CL after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Vd (Phase I)
Vd after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters t1/2 (Phase I)
t1/2 after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters λz (Phase I)
λz after single administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Css,max (Phase I)
Css,max after multiple administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Css,min (Phase I)
Css,min after multiple administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Css,av (Phase I)
Css,av after multiple administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters AUCss (Phase I)
AUCss after multiple administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters CLss (Phase I)
CLss after multiple administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Vss (Phase I)
Vss after multiple administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters R (Phase I)
R after multiple administration
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters DF (Phase I)
DF after multiple administration.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Immunogenicity (Phase I)
The frequency of anti-drug antibodies (ADA) against IAP0971.(Phase I)
Measured: 3 months after end event visit
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
ORR (Phase II)
ORR as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
OS (Phase II)
OS as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
DCR (Phase II)
DCR as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Incidence of AEs and SAEs (Phase II)
To investigate the safety characteristics.
Measured: 3 months after end event visit
Incidence of ADA (Phase II)
The frequency of anti-drug antibodies (ADA) against IAP0971
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.
- First posted3 Sep 2024
- Study start31 Dec 2024
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581419
- Sponsor's protocol ID
- IAP0971-203
- Status last verified
- Jan 2025
- First submitted
- 22 Aug 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors
- ClinicalTrials.gov ID
- NCT06581419
- Acronym / sponsor ID
- IAP0971-203
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 3 Sep 2024 (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.
Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors.
Phase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer.
Detailed description
The study includes dose-escalation (Phase I) and dose-expansion (Phase II) clinical trials. Phase I clinical trials will be conducted first. After completing the dose-escalation phase, the plan is to determine the recommended Phase II dose (RP2D) in the maximum tolerated dose (MTD) group and proceed with the subsequent Phase II exploratory studies.
The objective of the Phase I dose-escalation phase is to preliminarily assess the safety and tolerability of IAP0971 and to determine the MTD based on the incidence of dose-limiting toxicities (DLTs) in each dose group. Phase II will use an open-label, non-randomized, single-arm, multicenter design. The study will evaluate adverse events and adverse reactions through clinical observation, vital sign monitoring, and laboratory tests. Tumor assessments will be conducted using RECIST 1.1 criteria: within 48 weeks of the first infusion of the investigational drug, assessments will be performed after every two cycles (±7 days), and after 48 weeks, assessments will occur every four cycles (±7 days) until disease progression, initiation of new anti-tumor therapy, investigator-determined ineligibility (e.g., intolerable adverse reactions), loss to follow-up, voluntary withdrawal, death, or study termination/suspension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phase I | Experimental | Drug: IAP0971Dose escalation (Phase I): 14 to 48 subjects with advanced malignancies are planned to be enrolled to initially investigate the safety and tolerability of IAP0971 and to determine the MTD based on the frequency of DLT in each dose arm.The starting dose of IAP0971 for injection is 0.0005 mg/kg, with a preset maximum escalation dose of 18.0 mg/kg, administered once every 3 weeks. |
| phase II | Experimental | Drug: IAP0971Dose Extension (Phase II) : Phase II will use an open-label, non-randomized, single-arm, multicenter design. Under the RP2D dose determined in Phase I, 20-30 untreated patients with advanced or metastatic non-small cell lung cancer, who are driver gene negative and PD-L1 positive (TPS ≥ 50%), will be enrolled. The drug IAP0971 is administered once every 3 weeks, and every 3 weeks is 1 cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age of 18-75 years old (including cut-off value), regardless of gender.
- Phase I only: patients with histologically confirmed advanced or metastatic malignant solid tumors who have failed to respond to standard treatment, who have no standard treatment options, who are not currently applicable to standard treatment, or who have been assessed by the investigator to benefit from this treatment.
- Phase II only: patients with histologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and definitive concurrent chemoradiotherapy. Note: For patients with locally advanced stage (stage IIIB/IIIC) who cannot accept radical concurrent/sequential chemoradiotherapy, they need to be evaluated by relevant professional physicians and confirmed by written records.
- Phase II only: no prior systemic antitumor therapy for locally advanced or metastatic NSCLC (except for patients who received adjuvant/neoadjuvant chemotherapy or definitive concurrent or sequential chemoradiotherapy for locally advanced disease and disease progression ≥6 months after the last treatment).
- Phase II only: PD-L1 positive (TPS≥50%) as determined by IHC, and patients were negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) by immunohistochemistry.
Key exclusion criteria (29 listed)
- Phase II only: small cell lung cancer or sarcomatoid lesion confirmed by histopathology.
- Phase II only: previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 /PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action.
- Phase I only: patients received anti-tumor therapy such as systemic chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of study drug; The following drugs were excluded according to the following criteria:
- ① Treatment with a small-molecule tyrosine kinase inhibitor within 2 weeks before the first dose;
- ② Palliative local treatment for non-target lesions within 2 weeks before the first dose; Patients received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, not including IL-11) within 2 weeks before the first dose;
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 |
|---|---|---|
| IAP0971Subjects receive IAP0971, which will be administered every 3 weeks in a 3-week cycle. | Drug | phase I, phase II |
Primary outcome
Frequency of adverse events (AEs) and SAEs (Phase I)
Time frame: 3 months after end event visit
To investigate the safety characteristics.progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data.
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).
PFS in dose expansion (Phase II)
Time frame: Baseline through up to 2 years or until disease progression
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.
23 secondary outcomes
pharmacokinetic parameters Cmax (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Tmax (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters AUC 0-t (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters AUC 0-∞ (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters CL (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Vd (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters t1/2 (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters λz (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Css,max (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Css,min (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Css,av (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters AUCss (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters CLss (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters Vss (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters R (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
pharmacokinetic parameters DF (Phase I)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Immunogenicity (Phase I)
Time frame: 3 months after end event visit
Objective response rate (ORR) in dose escalation (Phase I)
Time frame: Baseline through up to 2 years or until disease progression
ORR (Phase II)
Time frame: Baseline through up to 2 years or until disease progression
OS (Phase II)
Time frame: Baseline through up to 2 years or until disease progression
DCR (Phase II)
Time frame: Baseline through up to 2 years or until disease progression
Incidence of AEs and SAEs (Phase II)
Time frame: 3 months after end event visit
Incidence of ADA (Phase II)
Time frame: 3 months after end event visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IAP0971 in people with Advanced Malignant Neoplasm and Advanced or Metastatic Non-small Cell Lung Cancer, 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 14 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: looking for participants now, as of the sponsor's last update on 15 Jan 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YuanKai Shi, doctor (8610-87788495, cancergcp@163.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?
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 15 Jan 2025.