Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Irinotecan

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine

* Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1\~Day5
* HM30181AK Tablet - Fixed dose 15 mg, Day1\~Day5
* Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1\~Day14

Oratecan in combination with Capecitabine

* Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1\~Day5
* HM30181AK Tablet - Fixed dose 15 mg, Day1\~Day5
* Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1\~Day14

Oratecan and Capecitabine

Jina Jung, PhD

The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine

Besides the main objective, there are 4 other objectives as follows:

* To assess the safety of Oratecan in combination with capecitabine
* To evaluate anticancer activity of Oratecan in combination with capecitabine in patients with advanced solid malignancies
* To characterize the pharmacokinetics of Oratecan and its metabolites following oral administration of OratecanTM in combination with capecitabine

Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies

A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer

If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)

by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)\*100.

Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)\*100.

Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)\*100.

Hanmi Pharmaceutical Company Limited

The patient took study medication until meet withdrawal criteria.

One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.

Capecitabine 800mg/㎡ + Oratecan 10mg/㎡

Capecitabine 800mg/㎡ + Oratecan 15mg/㎡

Capecitabine 800mg/㎡ + Oratecan 20mg/㎡

Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡

Total

Age, Continuous

Sex: Female, Male

Korea, Republic of

Region of Enrollment

Director of clinical research team

Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination

Objective Response rate

Response Rate

Disease Control Rate

Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)

Overall Study

Maleic acid

Henatinib either at 12.5,25,37.5,50,62.5,75,87.5 or 100 mg, p.o. once daily

henatinib

jin Li, Dr

Henatinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Henatinib in patients with Advanced Solid Malignancies

1. To evaluate the safety and tolerability of Henatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
2. To determine the pharmacokinetic profile of Henatinib and its metabolites .
3. To assess preliminary antitumor activity .
4. To determine preliminary regimen for phase II study .

A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies

Jiangsu HengRui Medicine Co., Ltd.

Participants received 50 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle.

Participants received 100 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle.

Participants received 200 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle.

Participants received 300 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle.

Participants received 400 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle.

Participants received 500 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle.

BPI-16350

Xichun XI Hu, Ph.D

Jiaying Li, B.S.

This was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.

The study was divided into two sections: dose escalation section and expanded enrollment section.

In dose escalation section, BPI-16350 were administered orally once daily (QD) to patients with locally advanced or metastatic solid tumors in different dose levels.The study was designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of BPI-16350.

In expanded enrollment section, based on the results of dose escalation section, BPI-16350 were administered orally to patients with locally advanced or metastatic solid tumors, to further evaluate the safety, tolerability, and pharmacokinetics of BPI-16350.

A Phase I Study of BPI-16350 in Patients With Advanced Solid Tumor

The safety and tolerability variables include adverse events, physical examinations, vital signs , clinical laboratory evaluations including serum chemistry, hematology , and urinalysis, and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs ( dose-limiting toxicity), To determine the MTD (maximum tolerated dose).

Day 1-7 for single dose, and day 1-28 for steady state

Betta Pharmaceuticals Co., Ltd.

Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.

JS015

Kai Xu, Project manager

Lin Shen, Medical Doctor

Tongsen Zheng, Medical Doctor

Yuping Sun, Medical Doctor

Jin Li, Medical Doctor

Jinming Yu, Medical Doctor

This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of JS015 in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） was determined based on the safety, pharmacokinetics, and initial efficacy data of the dose escalation and extension.

A Phase I Study Of JS015 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS015 In Patients With Advanced Solid Tumors

incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), Abnormal changes in laboratory and other tests with clinical significance

Maximum tolerated dose (MTD), Recommended dose for phase II trial

The highest plasma drug concentration that can be achieved after medication

After a single dose, the time of peak blood concentration

the time it takes the blood to reduce the concentration of the drug to half

Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)

The time from randomization to death from any cause

Sponsor GmbH

Shanghai Junshi Bioscience Co., Ltd.

Oral Once-Daily Administration of SH-1028

Starting dose 60mg,oral administered once daily.If tolerated subsequent cohorts will test increasing doses (120mg,180mg,240mg,320mg) of SH-1028.

SH-1028

JIN LI, MD

jin Li, MD

This is a Phase 1, open-label study of SH-1028 with dose escalation cohorts in locally advanced solid cancer patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent or standard treatment.

The study is designed to evaluate safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally (PO) administered SH-1028 tablets. The overall study design is shown in the flow chart below.

Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer

A Phase I, Open-label Study to Assess the Safety and Tolerability of Ascending Doses of SH-1028 Tablets in Patients With Advanced Solid Cancer

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Esophageal Neoplasms

Mesothelioma

Mesothelioma, Malignant

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Pleural Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Malignant Mesothelioma

APG-2449 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase and up to 30-40 patient at the MTD/RP2D dose level.

Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle

APG-2449

Yifan Zhai, M.D., Ph.D.

Jun Zhao, M.D.

Jian Fang, Ph.D.

Xiaoyan Lin, Ph.D

Wu Zhuang, Ph.D

LI ZHANG, Professor

Yubiao Guo, Professor

Yanqiu Zhao, Professor

Gang Wu, Professor

Jianhua Chen, Professor

Youling Gong, Professor

Yiping Zhang, Professor

Li Zhang, Professor

APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly.

Dose escalation of APG-2449 will use standard 3+3 design. The starting dose is 150 mg and will be increased in subsequent cohorts to 300mg, 450mg, 600mg, 750mg, 900mg, 1200mg and 1500mg, accordingly.

APG-2449 in Patients With Advanced Solid Tumors

A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors

To determine the maximum tolerated dose (MTD) of APG-2449 in subjects with advanced solid tumors

To determine the tentative recommended Phase 2 dose (RP2D) of APG-2449 in subjects with advanced solid tumors

Maximum plasma concentration (Cmax) will be assessed on all participants with APG-2449 treatments

Area under the plasma concentration versus time curve (AUC) will be assessed on all participants with APG-2449 treatments

Phosphorylation of FAK protein will be assessed in peripheral blood mononuclear cells on all participants with APG-2449 treatments

To assess preliminary efficacy in subjects with solid tumors using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Suzhou Yasheng Pharmaceutical Co., Ltd.

Ascentage Pharma Group Inc.

Docetaxel

Tubulin Modulators

Antimitotic Agents

Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, CKD-810 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.

CKD-810, Taxotere inj.

Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, Taxotere inj. 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.

JH Kang

The purpose of this study is to evaluate safety and the pharmacokinetic characteristics of docetaxel between two docetaxel products in patients with advanced solid cancer.

This is a Phase III study designed to evaluate the pharmacokinetic characteristics of docetaxel between two docetaxel products in patients with advanced solid cancer. This study will also assess the safety of the docetaxel in advanced solid cancer patients.

Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics of Docetaxel Between Two Docetaxel Products, CKD-810 and Taxotere Inj., in Patients With Advanced Solid Cancer

Chong Kun Dang Pharmaceutical

Jin Kim

SHR-A1904

Chunlei Jin, Ph.D.

Liang Hu

Ruihua Xu, Doctor

The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with advanced solid cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904

A Study of SHR-A1904 in Patients With Advanced Solid Cancer

An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies	NCT01463982	Solid Tumor Advanced Cancer	Oratecan and Ca...	19 Years -	Hanmi Pharmaceutical Company Limited
A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies	NCT01416623	Advanced Solid ...	henatinib	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
A Phase I Study of BPI-16350 in Patients With Advanced Solid Tumor	NCT03791112	Advanced Solid ...	BPI-16350	18 Years - 70 Years	Betta Pharmaceuticals Co., Ltd.
A Phase I Study Of JS015 in Patients With Advanced Solid Tumors	NCT05770310	Advanced Solid ...	JS015	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer	NCT03618043	Advanced Solid ...	SH-1028	18 Years - 75 Years	Nanjing Sanhome Pharmaceutical, Co., Ltd.
APG-2449 in Patients With Advanced Solid Tumors	NCT03917043	Advanced Solid ... Non Small Cell ... Esophageal Canc... Ovarian Cancer Malignant Pleur...	APG-2449	18 Years -	Ascentage Pharma Group Inc.
APG-2449 in Patients With Advanced Solid Tumors	NCT03917043	Advanced Solid ... Non Small Cell ... Esophageal Canc... Ovarian Cancer Malignant Pleur...	APG-2449	18 Years -	Ascentage Pharma Group Inc.
Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer	NCT03618043	Advanced Solid ...	SH-1028	18 Years - 75 Years	Nanjing Sanhome Pharmaceutical, Co., Ltd.
Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer	NCT01019941	Advanced Solid ...	CKD-810, Taxote... CKD-810, Taxote...	18 Years -	Chong Kun Dang Pharmaceutical
A Study of SHR-A1904 in Patients With Advanced Solid Cancer	NCT04877717	Advanced Solid ...	SHR-A1904	18 Years - 75 Years	Shanghai Hengrui Pharmaceutical Co., Ltd.
A Phase I Study of BPI-16350 in Patients With Advanced Solid Tumor	NCT03791112	Advanced Solid ...	BPI-16350	18 Years - 70 Years	Betta Pharmaceuticals Co., Ltd.

Spots Global Cancer Trial Database for advanced solid cancer