Clinical Trials/NCT05396391

NCT05396391

Recruiting

Phase 1

A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients With Advanced Malignant Tumors

SUNHO（China）BioPharmaceutical CO., Ltd.1 site in 1 country140 target enrollmentJune 22, 2022

ConditionsAdvanced Malignant Tumors

InterventionsIAP0971

DrugsIAP0971

Overview

Phase: Phase 1
Intervention: IAP0971
Conditions: Advanced Malignant Tumors
Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.
Enrollment: 140
Locations: 1
Primary Endpoint: To evaluate the safety of IAP0971 (Phase I)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors.

Detailed Description

The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa).First, the Phase Ia dose escalation will be carried out. After finishing the Phase 1a，the Phase Ib dose extension study can be carried out in the MTD dose which can be achieved from Phase 1a. After Phase Ia \& Ib are completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.

Registry

clinicaltrials.gov

Start Date

June 22, 2022

End Date

November 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

SUNHO（China）BioPharmaceutical CO., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 80 years, male or female.
•Patients with histologically or cytologically confirmed advanced or unresectable solid tumors or and relapsed and/or refractory non-Hodgkin's lymphoma, who have progressed on or have been intolerant to standard treatment, or for whom no standard treatment exists.
•Dose Escalation Phase (Part A)：At least one evaluable tumor lesion per RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas).
•Dose Expansion Phase (Part B)：At least one measurable tumor lesion per RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas).
•Agree to provide previously stored tumor tissue specimens or perform biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1 expression level detection.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
•(see Appendix 3)
•Adequate organ function: Hematological system (No blood transfusion or hematopoietic stimulating factor therapy within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L White blood cell count (WBC) ≥ 3.0 × 109/L Platelets (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 90 g/L Hepatic function Total bilirubin (TBIL) ≤ 3 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN; Aspartate aminotransferase (AST) ≤ 3 × ULN; Renal function Creatinine clearance (Ccr) (only calculated if creatinine \> 3 × ULN) ≥ 50 mL/min (calculated according to Cockcroft-Gault formula, see Appendix 7 for formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN
•Expected survival time of more than 3 months.
•Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partners during the trial and for at least 90 days after study drug administration; female patients of childbearing potential (see Appendix 8 for definition) must have a negative blood or urine pregnancy test 7 days before the first administration.

Exclusion Criteria

•Patients who have a severe hypersensitivity reaction to any monoclonal antibody (CTCAE 5.0 grade ≥ 3).
•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.
•Receipt of other non-marketed investigational drugs or treatments within 4 weeks before the first administration.
•Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first administration, or require elective surgery during the trial.
•Patients who have received systemic glucocorticoids (prednisone \> 10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first administration; exclude the following conditions: topical, ophthalmic, intra-articular, intranasal or inhaled corticosteroid therapy; short-term use of glucocorticoid for preventive treatment (for example, prevention of contrast agent allergy).
•Patients who have received immunomodulatory drugs within 14 days before the first administration, including but not limited to thymosin, interleukin-2, interferon, etc.
•Patients who have received live attenuated vaccines within 4 weeks before the first administration.
•Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
•The adverse reactions caused by previous anti-tumor treatment have not recovered to CTCAE 5.0 grade ≤ 1 (except for toxicity without safety risk as judged by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.).

Arms & Interventions

Phase Ia - Dose escalation

The goal of the Dose Escalation Phase (Part A) is to initially characterize the safety and tolerability of IAP0971, and more specifically to describe the DLTs for each dose level studied and to define the MTD based on the frequency of the occurrence of DLTs in each cohort during the DLT evaluation period.

Intervention: IAP0971

Phase Ib - Dose extension

During the Dose Expansion Phase , patients will be enrolled to receive IAP0971 at the MTD established from the Dose Escalation Phase of the study.

Intervention: IAP0971

Phase IIa - Clinical Exploratory Stage

After finishing Phase 1, invesigators will discuss with the sponsor about how to carry out the Phase IIa due to the results acheived from Phase I.

Intervention: IAP0971

Outcomes

Primary Outcomes

To evaluate the safety of IAP0971 (Phase I)

Time Frame: Through finishing Phase I, an average of 1 year

MTD/RP2D; Incidence and frequency of DLT; AE, SAE occurrence and frequency (according to NCI CTCAE 5.0).

To evaluate the effectiveness of IAP0971 (Phase IIa)

Time Frame: Until disease progression, assessed up to 3 years

Objective response rate(ORR)

Secondary Outcomes

Pharmacokinetics (PK) Cmax（Phase I)(After single dose ,assessed up to 1 year)
Pharmacokinetics (PK) CLss（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) Vss（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) Css,min（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) AUC0-t（Phase I)(After single dose ,assessed up to 1 year)
Pharmacokinetics (PK) AUC0-∞（Phase I)(After single dose ,assessed up to 1 year)
Pharmacokinetics (PK) Css,max（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) Css,av（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) AUCss（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) R（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) Vd（Phase I)(After single dose ,assessed up to 1 year)
Pharmacokinetics (PK) t1/2（Phase I)(After single dose ,assessed up to 1 year)
Pharmacokinetics (PK) λz（Phase I)(After single dose ,assessed up to 1 year)
Pharmacokinetics (PK) DF（Phase I)(After multiple doses ,assessed up to 1 year)
Pharmacokinetics (PK) Tmax（Phase I)(After single dose ,assessed up to 1 year)
To evaluate the immunogenicity of IAP0971 in patients with advanced malignant tumors (Phase I)(After finishing Phase I, an average of 1 year)
To evaluate the immunogenicity of IAP0971 in patients with advanced malignant tumors (Phase IIa)(After finishing Phase IIa, assessed up to 3 years)
Pharmacokinetics (PK) CL（Phase I)(After single dose ,assessed up to 1 year)
To evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase I)(After finishing Phase I, an average of 1 year)
o evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase IIa)(After finishing Phase IIa, assessed up to 3 years)