This is a Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors.
1. Age 18 to 75years, male or female.
2. Phase Ib:With advanced or metastatic malignant solid tumor confirmed by histopathology, the standard treatment fails, or there is no standard treatment plan, or standard treatment is not applicable at this stage, or the patient refuses the standard treatment, or the investigator evaluates the patient who can benefit from this treatment.
3.Phae II: Confirmed by histopathology that it is not feasible to perform complete resection and cannot be connected. Locally advanced (stage IIIB or IIIC) or metastatic (IV) after radical concurrent radiotherapy and chemotherapy Stage) non-small cell lung cancer (NSCLC). Note: For unacceptable radical synchronization/sequencing.Subjects with locally advanced stage IIIB/IIIC of radiotherapy and chemotherapy need to be evaluated by relevant professional doctors. And provide written records to confirm.
4.Phae II: Never received systemic anti-tumor therapy for locally advanced or metastatic NSCLC before. Tumor treatment(received adjuvant/neoadjuvant chemotherapy or radical treatment for locally advanced diseases) .Patients with synchronous or sequential radiotherapy and chemotherapy and disease progression occurred after the last treatment ≥6 months).
1.Phase II: Pathohistologically confirmed with small cell lung cancer components, or sarcomatoid lesions.
2. Phase II : Previous immunotherapy, including immune checkpoint inhibitors (such as PD-1/PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonist (such as:ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, etc.
3. Phase Ib: Patients who received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, and other anti-tumor treatment within 4 weeks before the first administration, except for the following: Nitrosourea or mitomycin C was received within 6 weeks before the first administration; Oral fluoropyrimidines and small molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first administration.Chinese proprietary medicines with anti-tumor indications were received within 2 weeks before the first administration.
4. Receipt of other non-marketed investigational drugs or treatments within 4 weeks before the first administration.
Sequential
IAP0971
DrugIAP0971 should be subcutaneous injected，q3w
Frequency of adverse events (AEs) and SAEs (Phase Ib)
To investigate the safety characteristics.
Dose limiting toxicities (DLTs) (Phase Ib)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
PFS in dose expansion (Phase II)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.
Pharmacokinetic (PK) Cmax (Phase Ib)
PK parameters (Cmax) following single dose.
Pharmacokinetic (PK) Cmin (Phase Ib)
PK parameters (Cmin) following single dose.
Pharmacokinetic (PK) Tmax (Phase Ib)
PK parameters (Tmax) following single dose.
Pharmacokinetic (PK) AUC 0-t (Phase Ib)
PK parameters (AUC 0-t) following single dose.
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