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Gland and Hormone Related Diseases

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Neoplasms by Histologic Type

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Genital Diseases

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All Drugs and Chemicals

Antibodies

Immunoglobulins

Five dose levels have been selected for evaluation in the Phase I part of the study: 2, 4, 6, 9, and 12 mg/kg of SKB264

Histologically documented or cytologically , incurable, locally advanced or metastatic cancer

Histologically documented or cytologically, incurable, locally advanced or metastatic cancer

Histologically or cytologically documented, incurable, locally advanced or metastatic cancer

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

SKB264

Study Manager

Zev Wainberg

Judy Wang

Manish Sharma

Rachel Sanborn

Jordie Rodon

Alexander Spira

Zhendong Chen

Yongsheng Li

Yanjun Mi

Li Zhang

Xiaozhong Chen

Xingya Li

Kunyu Yang

Yongzhong Luo

Bo Liu

Shuang Zhang

Huiting Xu

Nong Xu

Yun Fan

Xian Wang

Yunong Gao

Jun Zhao

Guangyu An An

Weihong Zhao

Ying Cheng

Quchang Ouyang

Wenxiu Yao

Dong Wang

Kui Jiang

Ying Wang

Ge Lou

Keqiang Zhang

Jingao Li

Longhua Sun

Yongmei Yin

Lihua Song

Dingwei Ye

Jin Li, MD

Tianshu Liu

Danbo Wang

Yunpeng Liu

Cuizhi Geng

Xia Song

Zhongsheng Tong

Ke Wang

Guohua Yu

Xinhong Wu

Xiaoping Zhang

Qiu Hui

Ruifang An

Xiang Wang

Min Yan

Jordi Rodon Ahnert, MD, PhD

A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types:

1. Triple negative breast cancer
2. Epithelial ovarian cancer
3. Non-small cell lung cancer
4. Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma
5. Small cell lung cancer
6. HR+/ HER2-breast cancer
7. Head and neck squamous cell carcinoma
8. Endometrial carcinoma
9. Urothelial carcinoma

This is an open label, Phase I-II, first in human (FIH) study for SKB264 as monotherapy in patients who have locally advanced unresectable or metastatic solid tumor that is refractory to all standard therapies. TROP2 (trophoblast antigen 2) assessments will not be performed prior to enrollment but it will be assessed retrospectively. Confirmation of TROP2 (trophoblast antigen 2) expression by immunohistology or other means is not required, but the Sponsor will request fresh tumor biopsy or tissue specimens from archived materials for determination of TROP2 (trophoblast antigen 2) expression retrospectively. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy whose tumor is refractory to standard therapies. Patients will receive study drug as a single IV infusion at the prescribed dose level at each administration. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II).

Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies

A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies

To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.

To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of SKB264 when administered intravenously (IV) as monotherapy at the RDEs to patients with metastatic or locally advanced unresectable tumors.

To determine the dose limiting toxicities (DLTs) of SKB264 when administered IV twice (on Days 1 and 15) every 2 weeks in 4 weeks (28 days) cycles as monotherapy to patients with metastatic or locally advanced unresectable tumors.

Percentage of patients with adverse events (AEs), serious adverse events (SAEs), AEs with Grade ≥ 3 per NCI CTCAE v5.0, adverse events of Special Interest (AESI) and AEs related to study drug.

ORR (Objective Response Rate) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + partial response (PR)

To evaluate preliminary efficacy in patients treated with SKB264 as monotherapy based on DOR(Duration of Response).

To evaluate preliminary efficacy in patients treated with SKB264 as monotherapy based on PFS(Progression-Free Survival).

To evaluate preliminary efficacy in patients treated with SKB264 as monotherapy based on OS(Overall Survival)

To assess the incidence of anti-drug antibody (ADA) formation to SKB264.

To characterize the PK of SKB264-ADC, SKB264 TAB, and free KL610023 payload, such as Cmax

To evaluate efficacy in patients treated with SKB264 as monotherapy based on DOR(Duration of Response)

To evaluate efficacy in patients treated with SKB264 as monotherapy based on PFS (Progression-Free Survival)

To evaluate efficacy in patients treated with SKB264 as monotherapy based on OS (Overall Survival)

To obtain Percentage of patients with ADA formation to SKB264.

To characterize the PK of SKB264-ADC, SKB264 TAB, and free KL610023 payload, such as half life

To assess levels of TROP2 expression in tumor tissue and correlation of those levels with responses and toxicity.

Klus Pharma Inc.

Spots Global Cancer Trial Database for trop2, adc

Every month we try and update this database with for trop2, adc 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 trop2, adc

Every month we try and update this database with for trop2, adc 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 trop2, adc 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.