Locally Advanced or Metastatic Non-small Cell Lung CancerPhase 1NCT06955988
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 1 study testing AST2303 Tablets(ABK3376 Tablets) ，25mg, AST2303 Tablets(ABK3376 Tablets) ，50mg and AST2303 Tablets(ABK3376 Tablets) ，75mg in people with Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial summary
This study is a multicenter, single arm, open label, phase I clinical trial, including dose escalation (phase IA) and dose expansion (phase IB). This study aimed to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of ast2303 tablets (abk3376 tablets) in subjects with locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Non-small Cell Lung Cancer
- What is being tested?
- AST2303 Tablets(ABK3376 Tablets) ，25mg, AST2303 Tablets(ABK3376 Tablets) ，50mg and AST2303 Tablets(ABK3376 Tablets) ，75mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Have fully understood this test and voluntarily sign the informed consent
- Age ≥ 18 at the time of signing the informed consent, regardless of gender
- Patients with non-small cell lung cancer confirmed by tissue / cytology.
- According to recist1.1 criteria, the presence of at least one target lesion without local treatment was assessed by the investigator
- Agree to provide blood samples and / or tumor tissue samples (fresh tissue or paraffin embedded tissue) for genetic testing
- The subject's bone marrow and organ functions are good (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before the first administration)
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- The ECoG physical status score is 0 or 1
- Expected survival time ≥ 12 weeks
- Have normal swallowing function
- Female subjects with fertility must have a serum pregnancy test within 7 days before the first administration, and the result is negative, and must be non lactating. For female subjects with fertility and male subjects with reproductive potential, effective contraceptive measures were taken from the signing of informed consent to 6 months after the last Administration
Who cannot join
- Previously received antitumor therapy targeting the c797s mutation
- Carry any other known driver gene alterations
- Have received any systemic anti-tumor treatment (including anti-tumor drugs in clinical research stage) within 2 weeks before the first administration or within 5 half lives of the drug (whichever is longer); Or receiving anti-tumor drugs with long half-life, such as immune checkpoint inhibitors, within 4 weeks before the first administration; Or received cytotoxic drugs with significant delayed toxicity, such as mitomycin C, within 6 weeks before the first administration;
- Have received non-specific immunomodulatory agents, traditional Chinese medicine or traditional Chinese medicine preparations with approved anti-tumor indications within 2 weeks before the first administration
- Strong inhibitors of CYP3A, P-gp or BCRP were used within 7 days before the first administration, or strong inducers of CYP3A, P-gp or BCRP were used within 3 weeks
- Local (non bone lesions) radiotherapy within 4 weeks before the first dose, or bone radiotherapy within 2 weeks before the first dose;
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- Other malignant tumors besides the primary tumor
- Subjects known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and / or compression, active brain metastasis. For brain metastasis subjects who have received local treatment in the past, if they are clinically stable for at least 4 weeks before the first administration of study treatment and do not need to use glucocorticoids or anticonvulsants for at least 14 days before the first administration of study treatment, they can participate in the study
- The tumor invades the surrounding important organs and blood vessels or has the risk of esophago tracheal fistula or esophago pleural fistula
- The toxicity of previous anti-tumor treatment has not returned to grade ≤ 1 (NCI CTCAE version 5.0 evaluation), except for grade ≤ 2 alopecia and peripheral neuropathy
- Presence of cardiovascular and cerebrovascular disease or cardiovascular and cerebrovascular risk factors
- Uncontrollable systemic diseases
- There is a history of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment; Currently have ILD or non infectious pneumonia; Suspected ILD or noninfectious pneumonia that could not be excluded by imaging examination was present at screening
- Pulmonary complications lead to clinically serious lung damage, including but not limited to the following: A. any underlying lung disease; b. Any autoimmune, connective tissue or inflammatory disease that may involve the lungs; c. Previous unilateral pneumonectomy
- Severe acute or chronic infection
- Being under long-term systemic corticosteroid treatment with prednisone > 10 mg/ day or equivalent anti-inflammatory active drugs or any form of immunosuppressive treatment before the first administration. Subjects who need to use bronchodilators, inhaled or topical steroids or local steroid injections for treatment or as preventive medication for hypersensitivity reactions (such as medication before CT examination, etc.) can be included in the study
- Subjects who had undergone major surgery within 4 weeks before the first dose or were expected to undergo major surgery during the study period
- Bleeding symptoms with significant clinical significance or obvious bleeding tendency within 4 weeks before the first administration, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis, etc
- It is known that there are serious gastrointestinal dysfunction: such as untreated recurrent diarrhea, moderate to severe atrophic gastritis, gastrointestinal obstruction, Crohn's disease, ulcerative colitis, gastrointestinal perforation, etc
- Known to have a history of hypersensitivity to the ingredients of the preparation used in the test
- Pregnant or lactating women or women planning to become pregnant during the study
- In the judgment of the investigator, the subject has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the subject or the collection of test data, etc
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd contact
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Chen zhonglin Chen zhonglin，research associate, research associate, 021-22200000, chestgcp@126.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
This study is a multicenter, single arm, open label, phase I clinical trial, including dose escalation (phase IA) and dose expansion (phase IB). This study aimed to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of ast2303 tablets (abk3376 tablets) in subjects with locally advanced or metastatic non-small cell lung cancer. A safety review committee (SRC) was established in this study, which will review the safety, efficacy, pharmacokinetics and other data obtained from the study, and make decisions on key issues such as dose escalation and dose expansion.
- Being tested
- AST2303 Tablets(ABK3376 Tablets) ，25mg, AST2303 Tablets(ABK3376 Tablets) ，50mg, AST2303 Tablets(ABK3376 Tablets) ，75mg, AST2303 Tablets(ABK3376 Tablets) ，100mg, AST2303 Tablets(ABK3376 Tablets) ，125mg
- Keywords
- EGFR L858R-C797S, Del19-C797S
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST2303 Tablets(ABK3376 Tablets) ，25mgDrug
Usage and dosage: 25mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
AST2303 Tablets(ABK3376 Tablets) ，50mgDrug
Usage and dosage: 50mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
AST2303 Tablets(ABK3376 Tablets) ，75mgDrug
Usage and dosage: 75mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
AST2303 Tablets(ABK3376 Tablets) ，100mgDrug
Usage and dosage: 100mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
AST2303 Tablets(ABK3376 Tablets) ，125mgDrug
Usage and dosage: 125mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| AST2303 Tablets(ABK3376 Tablets) ，25mg | Experimental | AST2303 Tablets(ABK3376 Tablets) ，25mg Receives: Drug: AST2303 Tablets(ABK3376 Tablets) ，25mg |
| AST2303 Tablets(ABK3376 Tablets) ，50mg | Experimental | AST2303 Tablets(ABK3376 Tablets) ，50mg Receives: Drug: AST2303 Tablets(ABK3376 Tablets) ，50mg |
| AST2303 Tablets(ABK3376 Tablets) ，75mg | Experimental | AST2303 Tablets(ABK3376 Tablets) ，75mg Receives: Drug: AST2303 Tablets(ABK3376 Tablets) ，75mg |
| AST2303 Tablets(ABK3376 Tablets) ，100mg | Experimental | AST2303 Tablets(ABK3376 Tablets) ，100mg Receives: Drug: AST2303 Tablets(ABK3376 Tablets) ，100mg |
| AST2303 Tablets(ABK3376 Tablets) ，125mg | Experimental | AST2303 Tablets(ABK3376 Tablets) ，125mg Receives: Drug: AST2303 Tablets(ABK3376 Tablets) ，125mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event, AE
AE will be classified based on the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) of the International Conference on Harmonisation of Registration Techniques for Medicinal Products for Human Use (ICH), and graded according to CTCAE 5.0.
Measured: Up to 2 years
Serious Adverse Event (SAE)
Measured: Up to 2 years
Adverse Events of Special Concern (AESI)
Measured: Up to 2 years
Objective response rate (ORR)
ORR is defined as the proportion of subjects confirmed as CR or PR to the total number of subjects, and the confirmation of remission is based on a follow-up evaluation conducted at least 28 days apart using the RECIST v1.1 evaluation criteria.
Measured: Up to 2 years
Disease Control Rate (DCR)
DCR is defined as the sum of the proportions of subjects whose disease is confirmed to have improved (including CR, PR) or stabilized (SD) after the start of treatment.
Measured: Up to 2 years
Duration of Relief (DOR)
DOR is defined as the time from the first recorded CR or PR to the first recorded imaging of disease progression (evaluated according to RECIST v1.1 criteria) or death from any cause (whichever occurs first) in a subject confirmed as ORR. Subjects who did not report disease progression or death during analysis will be subject to deletion on the date of the last tumor assessment.
Measured: Up to 2 years
Progression free survival (PFS)
PFS is defined as the time from the date of first medication to the date of first recorded disease progression (evaluated according to RECIST v1.1 criteria) or death from any cause (whichever occurs first).
Measured: Up to 2 years
Overall survival (OS)
OS is defined as the time from the date of initial medication to the date of death from any cause (whichever occurs first). Subjects who were not reported as deceased during the analysis, or subjects who were reported dead but had an unknown date of death (i.e. missing year, month, day, etc.), will be deleted from the last known date of survival.
Measured: Up to 2 years
Secondary outcomes (3)
Peak Time (Tmax)
Measured: Up to 2 years
Peak Plasma Concentration (Cmax)
Measured: Up to 2 years
From 0 to the last measurable time point t, the area under the drug time curve (AUC0-t)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start4 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955988
- Sponsor's protocol ID
- ALSC001AST2303
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06955988
- Acronym / sponsor ID
- ALSC001AST2303
- Keywords
- EGFR L858R-C797S, Del19-C797S
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 May 2025 (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.
This study is a multicenter, single arm, open label, phase I clinical trial, including dose escalation (phase IA) and dose expansion (phase IB). This study aimed to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of ast2303 tablets (abk3376 tablets) in subjects with locally advanced or metastatic non-small cell lung cancer. A safety review committee (SRC) was established in this study, which will review the safety, efficacy, pharmacokinetics and other data obtained from the study, and make decisions on key issues such as dose escalation and dose expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AST2303 Tablets(ABK3376 Tablets) ，25mg | Experimental | Drug: AST2303 Tablets(ABK3376 Tablets) ，25mgAST2303 Tablets(ABK3376 Tablets) ，25mg |
| AST2303 Tablets(ABK3376 Tablets) ，50mg | Experimental | Drug: AST2303 Tablets(ABK3376 Tablets) ，50mgAST2303 Tablets(ABK3376 Tablets) ，50mg |
| AST2303 Tablets(ABK3376 Tablets) ，75mg | Experimental | Drug: AST2303 Tablets(ABK3376 Tablets) ，75mgAST2303 Tablets(ABK3376 Tablets) ，75mg |
| AST2303 Tablets(ABK3376 Tablets) ，100mg | Experimental | Drug: AST2303 Tablets(ABK3376 Tablets) ，100mgAST2303 Tablets(ABK3376 Tablets) ，100mg |
| AST2303 Tablets(ABK3376 Tablets) ，125mg | Experimental | Drug: AST2303 Tablets(ABK3376 Tablets) ，125mgAST2303 Tablets(ABK3376 Tablets) ，125mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have fully understood this test and voluntarily sign the informed consent
- Age ≥ 18 at the time of signing the informed consent, regardless of gender
- Patients with non-small cell lung cancer confirmed by tissue / cytology.
- According to recist1.1 criteria, the presence of at least one target lesion without local treatment was assessed by the investigator
- Agree to provide blood samples and / or tumor tissue samples (fresh tissue or paraffin embedded tissue) for genetic testing
Key exclusion criteria (22 listed)
- Previously received antitumor therapy targeting the c797s mutation
- Carry any other known driver gene alterations
- Have received any systemic anti-tumor treatment (including anti-tumor drugs in clinical research stage) within 2 weeks before the first administration or within 5 half lives of the drug (whichever is longer); Or receiving anti-tumor drugs with long half-life, such as immune checkpoint inhibitors, within 4 weeks before the first administration; Or received cytotoxic drugs with significant delayed toxicity, such as mitomycin C, within 6 weeks before the first administration;
- Have received non-specific immunomodulatory agents, traditional Chinese medicine or traditional Chinese medicine preparations with approved anti-tumor indications within 2 weeks before the first administration
- Strong inhibitors of CYP3A, P-gp or BCRP were used within 7 days before the first administration, or strong inducers of CYP3A, P-gp or BCRP were used within 3 weeks
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 |
|---|---|---|
| AST2303 Tablets(ABK3376 Tablets) ，25mgUsage and dosage: 25mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle | Drug | AST2303 Tablets(ABK3376 Tablets) ，25mg |
| AST2303 Tablets(ABK3376 Tablets) ，50mgUsage and dosage: 50mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle | Drug | AST2303 Tablets(ABK3376 Tablets) ，50mg |
| AST2303 Tablets(ABK3376 Tablets) ，75mgUsage and dosage: 75mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle | Drug | AST2303 Tablets(ABK3376 Tablets) ，75mg |
| AST2303 Tablets(ABK3376 Tablets) ，100mgUsage and dosage: 100mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle | Drug | AST2303 Tablets(ABK3376 Tablets) ，100mg |
| AST2303 Tablets(ABK3376 Tablets) ，125mgUsage and dosage: 125mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle | Drug | AST2303 Tablets(ABK3376 Tablets) ，125mg |
Primary outcome
Adverse Event, AE
Time frame: Up to 2 years
AE will be classified based on the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) of the International Conference on Harmonisation of Registration Techniques for Medicinal Products for Human Use (ICH), and graded according to CTCAE 5.0.
Serious Adverse Event (SAE)
Time frame: Up to 2 years
Adverse Events of Special Concern (AESI)
Time frame: Up to 2 years
Objective response rate (ORR)
Time frame: Up to 2 years
ORR is defined as the proportion of subjects confirmed as CR or PR to the total number of subjects, and the confirmation of remission is based on a follow-up evaluation conducted at least 28 days apart using the RECIST v1.1 evaluation criteria.
Disease Control Rate (DCR)
Time frame: Up to 2 years
DCR is defined as the sum of the proportions of subjects whose disease is confirmed to have improved (including CR, PR) or stabilized (SD) after the start of treatment.
Duration of Relief (DOR)
Time frame: Up to 2 years
DOR is defined as the time from the first recorded CR or PR to the first recorded imaging of disease progression (evaluated according to RECIST v1.1 criteria) or death from any cause (whichever occurs first) in a subject confirmed as ORR. Subjects who did not report disease progression or death during analysis will be subject to deletion on the date of the last tumor assessment.
Progression free survival (PFS)
Time frame: Up to 2 years
PFS is defined as the time from the date of first medication to the date of first recorded disease progression (evaluated according to RECIST v1.1 criteria) or death from any cause (whichever occurs first).
Overall survival (OS)
Time frame: Up to 2 years
OS is defined as the time from the date of initial medication to the date of death from any cause (whichever occurs first). Subjects who were not reported as deceased during the analysis, or subjects who were reported dead but had an unknown date of death (i.e. missing year, month, day, etc.), will be deleted from the last known date of survival.
3 secondary outcomes
Peak Time (Tmax)
Time frame: Up to 2 years
Peak Plasma Concentration (Cmax)
Time frame: Up to 2 years
From 0 to the last measurable time point t, the area under the drug time curve (AUC0-t)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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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.
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AST2303 Tablets(ABK3376 Tablets) ，25mg, AST2303 Tablets(ABK3376 Tablets) ，50mg and AST2303 Tablets(ABK3376 Tablets) ，75mg in people with Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd (021-80423288, zhenhua.gong@allist.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event, AE (time frame: Up to 2 years). The study lists 8 primary outcomes in all. 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 13 Aug 2026.