A Phase I/II Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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).

• 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.

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
YuanKai Shi, doctor
cancergcp@163.com
8610-87788495
Time Frame
Start Date: 2024-12-31
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 78
Treatments
Experimental: phase I
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.
Experimental: phase II
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
Sponsors
Leads: SUNHO(China)BioPharmaceutical CO., Ltd.

This content was sourced from clinicaltrials.gov

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