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Lung CancerPhase 1/2NCT04993391

AP-L1898 Capsule in Patients With Non-small Cell Lung Cancer

A Phase 1/2 study testing JS111(AP-L1898 Capsules) in people with Lung Cancer, run by Suzhou Junjing BioSciences Co., Ltd. at 37 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase I/II, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS111 for patients with Non-small cell lung cance. This study is divided into 3 periods: dose escalation stage, dose extension stage, and efficacy extension stage. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
JS111(AP-L1898 Capsules)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
37 sitesChina
Study dates
14 Jul 2021to 4 Feb 2024
Phase
Phase 1/2
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

None listed.

Who cannot join

  • Use of any chemotherapeutic agen within 14 days prior to the first dose of AP-L1898; or the time from discontinuation of other investigational product to the use of anticancer drug less than 5 half-lives or 28 days, whichever is shorter;
  • EGFR exon 20 insertion cohort in efficacy-extension stage: once used the drugs targeting EGFR exon 20 insertion mutation (e.g., AZD9291, TAK-788, Poziotinib, CLN-081, JNJ-372, etc.); the patients previously receiving AZD9291 for treatment of EGFR sensitive mutation are allowed to be enrolled;
  • Ongoing use of CYP3A potent inhibitor or inducer, or discontinuation of potent inhibitor less than 5 half-lives of the drug, or discontinuation of potent inducer less than 5 half-lives of the drug or 14 days (whichever is longer) at the first dose of AP-L1898;
  • Not recovered from the adverse event induced by previous antitumor therapy at screening (recovered to ≤ grade 1) (except alopecia);
  • Having other malignant tumors within 5 years prior to the start of treatment or simultaneously (except radically treated non-melanoma without evidence on recurrence of disease, including skin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma in situ, superficial bladder cancer and other carcinomas in situ);
  • Presence of active gastrointestinal disease or other conditions that may obviously affect absorption, metabolism or excretion of drugs;
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  • Patients who known to have received organ transplantation;
  • Major surgery performed within 28 days prior to the first dose. Small surgery permitted, e.g., minimally invasive biopsy;
  • Patents with carcinomatous meningitis, spinal cord compression at present;
  • At rested state, mean corrected QT interval QTc, using Fridericia's correction formula>450 ms in man or >470 ms in woman on electrocardiography (ECG) (repeated for three times). A variety of clinically significant abnormalities in cardiac rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, degree III heart block, degree II heart block, PR interval>250 ms. Any factors that may increase the risk of prolonged QTc interval or risk of arrhythmic events, e.g., heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in lineal relatives, or ongoing use of any drug known to prolong QT interval;
  • History of poorly controlled hypertension;
  • Previous history of the following diseases: interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, active interstitial lung disease with clinical evidence;
  • Patients with active brain metastasis, if the CNS metastasis is only limited to supratentorial area or cerebellum that has been adequately treated (surgery or radiotherapy) and radiologically stable for at least 4 weeks, and no corticosteroid is needed to control symptoms, the patients will be allowed to be enrolled;
  • In acute infection phase and requiring pharmacotherapy;
  • HBV DNA≥103 copies/mL or ≥200 IU/mL when the hepatitis B surface antigen is positive or hepatitis B core antibody is positive;
  • HCV-RNA > the upper limit of reference at the site when hepatitis C antibody is positive;
  • Human immunodeficiency virus (HIV) antibody positive;
  • Patient with a previous history of clear mental disorder and taking drugs for treatment;
  • Patient with a history of drug abuse or drug taking;
  • Pregnant or lactating women;
  • Presence of other factors that may possibly affect the study results, interfere with their participation in the entire study, including previous or current physical condition (e.g., ocular disease, including corneal ulcer, conjunctivitis, etc.), treatment or laboratory examination abnormality, unwillingness to comply with each procedure, restriction and requirement in the study, as considered by investigators.
  • A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest. Use a bulleted list for each criterion below the headers ""Inclusion Criteria"" and ""Exclusion Criteria"". (Limit: 15,000 characters.)"

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha

  • Chinese People's Liberation Army Army Characteristic Medical Center

    Chongqing, Chongqing Municipality, 400042

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen Memorial Hospital ], Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510163

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang, 150081

  • Hangzhou Cancer Hospital

    Hangzhou, Zhejiang, 310002

  • The First Affiliated Hospital , Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650106

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200127

  • Shanghai Pulmonary Hospital

    Shanghai

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • Cancer Hospital Chinese Academy of Medical Sciences，Shenzhen center

    Shenzhen, Guangdong, 518116

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

  • Weifang People's Hospital

    Weifang, Shandong, 261000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430023

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • North Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524023

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Dose-escalation, Dose-extension and Efficacy-extension, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of AP-L1898 Capsule for the Treatment of the Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

This is a phase I/II, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS111 for patients with Non-small cell lung cance. This study is divided into 3 periods: dose escalation stage, dose extension stage, and efficacy extension stage.

Conditions
Lung Cancer
Being tested
JS111(AP-L1898 Capsules)
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS111(AP-L1898 Capsules)Drug

    40 mg, QD

  • JS111(AP-L1898 Capsules)Drug

    80 mg, QD

  • JS111(AP-L1898 Capsules)Drug

    160 mg, QD

  • JS111(AP-L1898 Capsules)Drug

    240 mg, QD

  • JS111(AP-L1898 Capsules)Drug

    320 mg, QD

Study groups in NCT04993391
Study groupRoleWhat they receive
40mg dose.ExperimentalThe subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational per
Receives: Drug: JS111(AP-L1898 Capsules)
80mg dose.ExperimentalThe subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational per
Receives: Drug: JS111(AP-L1898 Capsules)
160mg dose.ExperimentalThe subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational pe
Receives: Drug: JS111(AP-L1898 Capsules)
240mg dose.ExperimentalThe subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational pe
Receives: Drug: JS111(AP-L1898 Capsules)
320mg dose.ExperimentalThe subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational pe
Receives: Drug: JS111(AP-L1898 Capsules)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety assessed by the adverse event

    The AEs summary will be provided.

    Measured: up to 3 years

  2. Safety assessed by the serious adverse event

    The SAEs summary will be provided.

    Measured: up to 3 years

  3. Safety assessed by the physical examinatin

    The abnormal physical examinatin summary will be provided.

    Measured: up to 3 years

  4. Safety assessed by the ECOG score

    The worsening ECOG score summary will be provided.

    Measured: up to 3 years

  5. Safety assessed by the ophthalmic examination

    The ophthalmic examination summary will be provided.

    Measured: up to 3 years

  6. ORR

    The ORR summary will be calculated.

    Measured: up to 3 years

Secondary outcomes (10)

  1. Cmax

    observed maximum plasma concentration of AP-L1898

    Measured: 0up to 3 years

  2. Tmax

    time ro reach maximum plasam concentration of AP-L1898

    Measured: up to 3 years

  3. AUC 0-t

    Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t)

    Measured: up to 3 years

  4. t1/2

    Elimination half life time

    Measured: up to 3 years

  5. CL/F

    apparent clearance (CL/F)

    Measured: up to 3 years

  6. Vd/F

    Apparent volume of distribution (Vd/F)

    Measured: up to 3 years

  7. DoR

    the time from the first evaluation of CR or PR to the first evaluation of PD or death for any reason. For the subjects who have no progression but survive persistently after meeting the response criteria, the duration of response will be censored on the date of the last evaluable tumor evaluation or the last follow-up of progression of disease.

    Measured: up to 3 years

  8. OS

    Kaplan-Meimer method will be used to plot survival curve, while the median survival will be calculated.

    Measured: up to 3 years

  9. DCR

    the proportion of subjects with CR, PR or SD as the best response in accordance with RECIST1.1.

    Measured: up to 3 years

  10. Plasma drug concentration after administration of study drug

    The actual date and time of collection of each PK sample (24h system, accurate to minute) will be recorded in the study. Except an accurate record of the actual time point for collection of PK sample, the administration also needs to be recorded to evaluate PK data. The plasma concentrations of AP-L1898 and its metabolites will be determined using validated LC-MS/MS method.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start14 Jul 2021
  3. Primary completion4 Feb 2024
  4. Study completion4 Feb 2024

Why it stopped: The study was stopped because of a change in the study strategy

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993391
Sponsor's protocol ID
JS111-001-I
Status last verified
Sep 2026
First submitted
10 Jun 2021
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JS111(AP-L1898 Capsules) in people with Lung Cancer, run by Suzhou Junjing BioSciences Co., Ltd. at 37 sites in China.

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 0 inclusion and 22 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: stopped early, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: The study was stopped because of a change in the study strategy). Results are not available in the source record.

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 assessed by the adverse event (time frame: up to 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04993391.

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 10 Sep 2026.

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