IAP0971 should be subcutaneous injected，q3w

IAP0971

Kai Yuan Shi, doctor

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

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

A Clinical Trial of Phase Ib/II to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

To investigate the safety characteristics.

To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

To explore the clinical effectiveness. Tumor response based on RECIST 1.1.

PK parameters (Cmax) following single dose.

PK parameters (Cmin) following single dose.

PK parameters (Tmax) following single dose.

PK parameters (AUC 0-t) following single dose.

PK parameters (AUC 0-∞) following single dose.

PK parameters (Vd) following single dose.

PK parameters (t1/2) following single dose.

PK parameters (λz) following single dose.

PK parameters (Css,max) following multiple dose.

PK parameters (Css,min) following multiple dose.

PK parameters (Css,av) following multiple dose.

PK parameters (AUCss) following multiple dose.

PK parameters (CLss) following multiple dose.

PK parameters (Vss) following multiple dose.

PK parameters (R) following multiple dose.

PK parameters (DF) following multiple dose.

The frequency of anti-drug antibodies (ADA) against IAP0971.(Phase Ib)

The frequency of anti-drug antibodies (ADA) against IAP0971.(Phase II)

SUNHO（China）BioPharmaceutical CO., Ltd.

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.

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

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.

IAP0971 should be subcutaneous injected，q2w

Minwei Manager

Jin Li, master

Jin Li, M.D.

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

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.

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

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

PK parameters Css,max following multiple doses

PK parameters Css,min following multiple doses

PK parameters Css,av following multiple doses

PK parameters AUCss following multiple doses

PK parameters CLss following multiple doses

PK parameters Vss following multiple doses

PK parameters DF following multiple doses

PK parameters AUC0-t following single dose

PK parameters AUC0-∞ following single dose

Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAb) against IAP0971

Overall survival (OS) according to RECIST 1.1 or Lugano 2014

Objective response rate (ORR) according to RECIST 1.1 or Lugano 2014

PFS according to RECIST 1.1 or Lugano 2014

DCR according to RECIST 1.1 or Lugano 2014

OS according to RECIST 1.1 or Lugano 2014

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

BCG Vaccine

Tannic Acid

Phase Ia study: for adults with BCG treatment failure or intolerance to BCG, high-risk non muscle invasive bladder cancerPatient, evaluate the safety and tolerability of IAP0971 monotherapy bladder infusion, and determine dose limiting toxicity and/or phase II recommended dose.

Phase Ib study:To evaluate the safety and tolerability of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk non-muscle invasive bladder cancer, and to determine the DLT and RP2D.

Phase II study:To evaluate the efficacy of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk NMIBC using RP2D as determined in the phase I study.

Induction period (6 weeks): IAP0971 single drug bladder infusion, once a week;Maintenance period: IAP0971 single drug bladder infusion, performed at 3, 6, 12, 18, and 24 months, once a week, for 3 consecutive times

Induction period (6 weeks): IAP0971 combined with BCG,Bladder perfusion, once a week;Maintenance period: IAP0971 combined with BCG bladder perfusion,Maintain at months 3, 6, 12, 18, and 24Perfusion, once a week, three times in a row.

IAP0971＋BCG

Induction period (6 weeks): IAP0971 combined with BCG,Bladder perfusion, once a week;Maintenance period: IAP0971 combined with BCG bladder irrigationNote, progress at months 3, 6, 12, 18, and 24Perform maintenance perfusion once a week, three times in a row.

wang xinshi, B.D.

ye dingwei, M.D.

The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.

Phase Ia study: for adults with BCG treatment failure or intolerance to BCG, high-risk non muscle invasive bladder cancerPatient, evaluate the safety and tolerability of IAP0971 monotherapy bladder infusion, and determine dose limiting toxicity and/or phase II recommended dose.

Phase Ib study:To evaluate the safety and tolerability of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk non-muscle invasive bladder cancer, and to determine the DLT and RP2D.

Phase II study:To evaluate the efficacy of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk NMIBC using RP2D as determined in the phase I study.

A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer

A Phase I/II Clincal Trial of Intravesical IAP0971 in Combination With Bacillus Calmette Guerin (BCG) in Patients With BCG Unresponsive High Risk Non-Muscular Invasive Bladder Cancer (NMIBC)

The DLT evaluation period is defined as 21 days after the first administration of investigational product.

During DLT evaluation period, if ≥2 cases DLTs occur in the 3 or 6 subjects in one dose group, the previous dose is defined as MTD.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors	NCT06223841	Advanced Malign...	IAP0971	18 Years - 75 Years	SUNHO（China）BioPharmaceutical CO., Ltd.
A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors	NCT05396391	Advanced Malign...	IAP0971	18 Years - 80 Years	SUNHO（China）BioPharmaceutical CO., Ltd.
A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer	NCT06255964	Bladder Cancer	IAP0971 IAP0971＋BCG IAP0971＋BCG	18 Years -	SUNHO（China）BioPharmaceutical CO., Ltd.

Spots Global Cancer Trial Database for iap0971

Every month we try and update this database with for iap0971 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iap0971

Every month we try and update this database with for iap0971 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iap0971 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.