Advanced CancerPhase 1NCT04257617
A Trial of ZL-1201 in Subjects With Advanced Cancer
A Phase 1 study testing ZL-1201 in people with Advanced Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 7 sites in 2 countries.
Trial summary
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- ZL-1201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 11 May 2020to 19 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known active brain metastases
- Red blood cells transfusion dependence
- Known cardiopulmonary disease
- Pregnant or breast-feeding females
- Any other serious underlying medical
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
US2005
Jacksonville, Florida, 32224
US2002
New York, New York, 11776
US2004
Phoenix, Arizona, 85259
US2001
Rochester, Minnesota, 55905
US2003
St Louis, Missouri, 63110
About this study
Official title: First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
Read the detailed description
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.
- Conditions
- Advanced Cancer
- Being tested
- ZL-1201
- Keywords
- Advanced solid tumors or hematologic malignancies
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-1201Drug
Also called Monotherapy
Part 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.
| Study group | Role | What they receive |
|---|---|---|
| Single arm, ZL-1201 | Experimental | Single arm, ZL-1201 Receives: Drug: ZL-1201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the time of informed consent to 30 days after last dose
Secondary outcomes (7)
Pharmacokinetics：AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Measured: Up to 30 days after last dose
Pharmacokinetics: Cmax
Maximum serum concentration(Cmax) of the drug after the administration
Measured: Up to 30 days after last dose
Pharmacokinetics: t1/2
Half-life(t1/2) of the drug
Measured: Up to 30 days after last dose
Pharmacokinetics: CL
Total body clearance of the drug
Measured: Up to 30 days after last dose
Pharmacokinetics: Vss
Volume of the distrubution at steady-state
Measured: Up to 30 days after last dose
Immunogenicity
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity
Measured: Up to 30 days after last dose
Overall Response Rate (ORR）
ORR includes CR and PR
Measured: Up to 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start11 May 2020
- Primary completion17 May 2022
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Physician, Study director, Zai Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257617
- Sponsor's protocol ID
- ZL-1201-001
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT04257617
- Acronym / sponsor ID
- ZL-1201-001
- Conditions
- Advanced Cancer
- Keywords
- Advanced solid tumors or hematologic malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2020 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, ZL-1201 | Experimental | Drug: ZL-1201Single arm, ZL-1201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Known active brain metastases
- Red blood cells transfusion dependence
- Known cardiopulmonary disease
- Pregnant or breast-feeding females
- Any other serious underlying medical
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-1201Also: MonotherapyPart 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2. | Drug | Single arm, ZL-1201 |
Primary outcome
Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events
Time frame: From the time of informed consent to 30 days after last dose
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
7 secondary outcomes
Pharmacokinetics：AUC
Time frame: Up to 30 days after last dose
Pharmacokinetics: Cmax
Time frame: Up to 30 days after last dose
Pharmacokinetics: t1/2
Time frame: Up to 30 days after last dose
Pharmacokinetics: CL
Time frame: Up to 30 days after last dose
Pharmacokinetics: Vss
Time frame: Up to 30 days after last dose
Immunogenicity
Time frame: Up to 30 days after last dose
Overall Response Rate (ORR）
Time frame: Up to 2 years after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Physician study director
Zai Laboratory
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZL-1201 in people with Advanced Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events (time frame: From the time of informed consent to 30 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.