All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Immunoglobulins

RC48-ADC(Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate) JS001(Recombinant Humanized Anti-PD1 Monoclonal Antibody)

The study has 2 parts which include dose escalation phase and dose extension phase.

Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with HER2-Positive Advanced Malignant Solid Tumors sequentially at escalating doses of 2.0mg/kg and 2.5mg/kg to RC48-ADC and JS001 is fixed dose of 3.0mg/mg

RC48-ADC in combinaton with JS001

lin Shen, professor

Shen Lin, Professor

Shen Lin, professor

Lin Shen, professor

This is a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in Treatment of HER2-Positive Advanced Malignant Solid Tumors.

The study has 2 parts which include dose escalation phase and dose extension phase.

Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with HER2-Positive Advanced Malignant Solid Tumors sequentially at escalating doses of 2.0mg/kg and 2.5mg/kg to RC48-ADC and JS001 is fixed dose of 3.0mg/mg . Escalation will continue until identification of a MTD.

Dose of phase II and extenstion stage which based-results of escalation phase will be recommend.

JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors

A Phase I, Open-label, Dose Escalation Clinical Trial to Assess the Safety, Efficacy, Tolerability and Pharmacokinetics of the Recombinant Humanized Anti-PD1 Monoclonal Antiody (JS001) in Combination With Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate (RC48-ADC) in Treatment of HER2-Positive Advanced Malignant Solid Tumors

Side effects of drug or treatment that are serious enough to prevent an increase in dose or level of that treatment. The MTD is defined as the previous dose level.

Safety of participants followed for the duration of hospital stay, an expected average of 1 week

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

The percentage of patients who achieve complete remission(CR) or partial remission

anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

neutralizing anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

area under the plasma concentration versus time curve

RemeGen Co., Ltd.

Peking University

MD，Professor,Chief of Department of GI Oncology,Peking University Cancer Hospital

Antibodies, Bispecific

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

KN046 is a PD-L1 - CTLA-4 bispecific antibody.

KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme.

KN026 combined with KN046

Lin Shen, MD,PhD

This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.

The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.

KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor

A Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor

Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment

Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors	NCT04280341	HER2-Positive S...	RC48-ADC in com...	18 Years -	Peking University
KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor	NCT04040699	HER2 Positive S...	KN026 combined ...	18 Years - 75 Years	Peking University

Spots Global Cancer Trial Database for her2 positive solid tumor