NCT04257617

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2020

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

August 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

January 27, 2020

Last Update Submit

August 21, 2023

Conditions

Advanced Cancer

Keywords

Advanced solid tumors or hematologic malignancies

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events

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

    From the time of informed consent to 30 days after last dose

Secondary Outcomes (7)

  • Pharmacokinetics：AUC

    Up to 30 days after last dose

  • Pharmacokinetics: Cmax

    Up to 30 days after last dose

  • Pharmacokinetics: t1/2

    Up to 30 days after last dose

  • Pharmacokinetics: CL

    Up to 30 days after last dose

  • Pharmacokinetics: Vss

    Up to 30 days after last dose

  • +2 more secondary outcomes

Study Arms (1)

Single arm, ZL-1201

EXPERIMENTAL

Single arm, ZL-1201

Drug: ZL-1201

Interventions

ZL-1201DRUG

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

Also known as: Monotherapy
Single arm, ZL-1201

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists.
  • Adequate hematologic status
  • Adequate coagulation function
  • Adequate hepatic function
  • Adequate renal function

You may not qualify if:

  • Known active brain metastases
  • Red blood cells transfusion dependence
  • Known cardiopulmonary disease
  • Pregnant or breast-feeding females
  • Any other serious underlying medical

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

US2004

Phoenix, Arizona, 85259, United States

Location

US2005

Jacksonville, Florida, 32224, United States

Location

US2001

Rochester, Minnesota, 55905, United States

Location

US2003

St Louis, Missouri, 63110, United States

Location

US2002

New York, New York, 11776, United States

Location

CN1003

Chongqing, Chongqing Municipality, China

Location

CN1002

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Study Physician

    Zai Laboratory

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 6, 2020

Study Start

May 11, 2020

Primary Completion

May 17, 2022

Study Completion

January 19, 2023

Last Updated

August 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)US(5)