A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSUNHO（China）BioPharmaceutical CO., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
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).
Trial design
Design model
Sequential
Treatments tested in this trial
IAP0971
DrugSubjects receive IAP0971, which will be administered every 3 weeks in a 3-week cycle.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: phase IExperimental treatment 1 intervention
Group B: phase IIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months after end event visit2
Dose limiting toxicities (DLTs) (Phase I)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Time frame
21 days after first dose3
PFS in dose expansion (Phase II)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.
Time frame
Baseline through up to 2 years or until disease progressionSecondary outcomes
1
pharmacokinetic parameters Cmax (Phase I)
Cmax after single administration
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 years2
pharmacokinetic parameters Tmax (Phase I)
Tmax after single administration
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 years3
pharmacokinetic parameters AUC 0-t (Phase I)
AUC 0-t after single administration
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 years4
pharmacokinetic parameters AUC 0-∞ (Phase I)
AUC 0-∞ after single administration
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 yearsSponsors and contacts
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Source ClinicalTrials.gov