A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
NCT Number: NCT06581419
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Malignant Neoplasm|Advanced or Metastatic Non-small Cell Lung Cancer
Interventions: DRUG: IAP0971
Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-08-01
Locations: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 10021, China

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.

Primary Outcome Measures: 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., 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)., 21 days after first dose|PFS in dose expansion (Phase II), To explore the clinical effectiveness. Tumor response based on RECIST 1.1., Baseline through up to 2 years or until disease progression
Secondary Outcome Measures: pharmacokinetic parameters Cmax (Phase I), Cmax after single administration, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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., 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), 3 months after end event visit|Objective response rate (ORR) in dose escalation (Phase I), Tumor response based on RECIST 1.1., Baseline through up to 2 years or until disease progression|ORR (Phase II), ORR as assessed using RECIST 1.1., Baseline through up to 2 years or until disease progression|OS (Phase II), OS as assessed using RECIST 1.1., Baseline through up to 2 years or until disease progression|DCR (Phase II), DCR as assessed using RECIST 1.1., Baseline through up to 2 years or until disease progression|Incidence of AEs and SAEs (Phase II), To investigate the safety characteristics., 3 months after end event visit|Incidence of ADA (Phase II), The frequency of anti-drug antibodies (ADA) against IAP0971, 3 months after end event visit