Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Part 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.

ZL-1201

Study Physician

First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer

This is a first-in-human, dose escalation trial of ZL-1201. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

A Trial of ZL-1201 in Subjects With Advanced Cancer

First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer

Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

The area under the curve (AUC) of serum concentration of the drug after the administration

Maximum serum concentration(Cmax) of the drug after the administration

Volume of the distrubution at steady-state

Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity

Zai Lab (Shanghai) Co., Ltd.

Hematologic Diseases

APG-1387 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase and up to 20 patient per group at the dose expansion phase.

Multiple dose cohorts, 30 minute IV infusion, once weekly for 3 weeks of a 21-day cycle

APG-1387 for Injection

Yifan Zhai, MD, PhD

APG-1387 is a potent, bivalent small-molecule Inhibitor of Apoptosis Protein (IAP) antagonist. APG-1387 has shown strong dose- and schedule-dependent antitumor activities in multiple human cancer xenograft models, APG-1387 also demonstrates its synergistic effect in combination with immune checkpoint inhibitor anti-PD-1 antibody, and such a combinatory effect was further enhanced by chemotherapeutic agent. A total of 35 patients with advanced solid tumors or lymphomas have been treated with APG-1387 in two Phase I dose-escalation studies in Australia and in China. Ten dose levels have been tested ranging from 0.3 mg to 45 mg in these two studies. Based on the preliminary results, APG-1387 is well-tolerated at the dose levels evaluated to date. APG-1387 is intended for the treatment of patients with advanced solid tumors and hematologic malignancies. After establishing the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several Ib /II studies will be implemented accordingly to further access the antitumor effects of APG-1387 in combination with either pembrolizumab or the chemotherapeutic agents.

APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies

A Phase I Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of APG-1387 as a Single Agent or in Combination With Systemic Anti-Cancer Agents in Patients With Advanced Solid Tumors or Hematologic Malignancies

Patients with APG-1387 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03

Response will be evaluated every 2 cycles (8 weeks), according to the revised RECIST Guideline, Version 1.1 or the Revised Response Criteria for Malignant Lymphoma

Maximum plasma concentration (Cmax) will be assessed in the patients treated with APG-1387

Tumor biopsy and peripheral blood sample at baseline and 15-21 days after administration of APG-1387 alone or in combination with systemic anti-cancer therapy

Area under the plasma concentration versus time curve (AUC) of APG-1387 will be assessed on patients treated with APG-1387

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial of ZL-1201 in Subjects With Advanced Cancer	NCT04257617	Advanced Cancer	ZL-1201	18 Years -	Zai Lab (Hong Kong), Ltd.
APG-1387 in Patients With Advanced Solid Tumors or Hematologic Malignancies	NCT03386526	Advanced Solid ...	APG-1387 for In...	18 Years -	Ascentage Pharma Group Inc.

Spots Global Cancer Trial Database for advanced solid tumors or hematologic malignancies