Advanced Malignant Neoplasm study: IAP0971
Official title A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT06581419
What this study is testing
What is IAP0971?
IAP0971 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for advanced malignant neoplasm.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Phase II only: patients with histologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-small cell lung cancer...
- Phase II only: no prior systemic antitumor therapy for locally advanced or metastatic NSCLC (except for patients who received adjuvant/neoadjuvant...
- Phase II only: PD-L1 positive (TPS≥50%) as determined by IHC, and patients were negative for epidermal growth factor receptor (EGFR) and anaplastic...
You likely can't join if
- 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...
- Phase I only: patients received anti-tumor therapy such as systemic chemotherapy, radiotherapy, biological therapy, endocrine therapy, or...
- 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...
- the adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 or the relevant requirements of the inclusion...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- people must give informed consent for this study and voluntarily provide written informed consent before the trial.
What rules you out
- 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.
- 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
- 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 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...
- 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.)
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.