Advanced Gastrointestinal TumorsPhase 2NCT07826195
A Phase IIa Study Evaluating Injectable ALK-N001 in Patients With Advanced Gastrointestinal Tumors
A Phase 2 study testing Injectable ALK-N001 in people with Advanced Gastrointestinal Tumors, run by Zhejiang Anglikang Pharmaceutical Co., Ltd..
Trial summary
This open-label, multicenter Phase IIa study is to evaluate the efficacy and safety of injectable ALK-N001 in patients with advanced gastrointestinal tumors, with the primary objective to assess its preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastrointestinal Tumors
- What is being tested?
- Injectable ALK-N001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Apr 2028
- Phase
- Phase 2
- 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
- Voluntarily sign informed consent, understand the study and be willing and able to comply with all study procedures.
- Age ≥18 years (male or female) at the time of signing informed consent.
- Histologically or cytologically confirmed locally advanced or metastatic esophageal squamous cell carcinoma, colorectal adenocarcinoma, or other gastrointestinal tumors.
- Disease progression or intolerance after prior standard-of-care (SoC) treatment:
- Cohort1 (ESCC): Not eligible for curative surgery/radiochemotherapy; progressed or intolerant after at least 1st-line platinum-based chemotherapy plus PD-(L)1 inhibitor. If immunotherapy is declined/ineligible, progressed after ≥2 lines of systemic therapy.
- Cohort2 (CRC): Received standard systemic therapy for metastatic colorectal cancer and experienced progression or intolerance. Must have received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy (±bevacizumab/cetuximab), unless contraindicated. For MSI-H/dMMR tumors, prior PD-(L)1 inhibitor is required.
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- Cohort3 (Other GI tumors): Not curable by surgery; disease progression/intolerance after standard-of-care therapy, or no available effective treatment.
- At least one measurable lesion per RECIST V1.1 (lesions in prior radiation field generally not measurable unless clear progression).
- ECOG performance status 0 or 1.
- Expected survival ≥3 months.
- Adequate organ function:
- Bone marrow (no transfusion/growth factors within prior 14 days): ANC ≥1.5×10⁹/L; PLT ≥90×10⁹/L; Hb ≥90 g/L
- Liver: TBIL ≤1.5×ULN; ALT ≤3×ULN (≤5×ULN for liver metastasis); AST ≤3×ULN (≤5×ULN for liver metastasis); ALB ≥35 g/L
- Renal: Cr ≤1.5×ULN; if Cr>1.5×ULN, CrCl ≥50 mL/min (Cockcroft-Gault formula)
- Coagulation: APTT ≤1.5×ULN; INR ≤1.5×ULN
- Women of childbearing potential must have negative pregnancy test at screening and agree to effective contraception or abstinence from consent until 6 months after last dose. Male participants must use effective contraception or abstinence from consent until 6 months after last dose; no sperm donation.
Who cannot join
- 1. Received chemotherapy, radiotherapy (palliative local radiotherapy within prior 2 weeks), biotherapy, targeted therapy, immunotherapy, TIL or other anti-tumor therapies within 4 weeks before first dose.
- Anti-endocrine therapy within 2 weeks or 5 half-lives; oral CDK4/6i, small molecule targeted agents, anti-tumor Chinese medicine.
- CAR-T, CAR-NK or tumor vaccine within prior 3 months.
- Live vaccine within 2 weeks; non-live vaccine within 4 weeks before first dose.
- Investigational drug within 4 weeks or 5 half-lives before first dose (whichever shorter).
- 2. Use of strong CYP3A4 inducer/inhibitor within 7 days before first dose or planned during study.
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- 3. Prior treatment with DXD-containing ADC or PDC. 4. Active infection at screening requiring systemic anti-infective therapy within 2 weeks prior to first dose.
- 5. Known BRAF mutation or NTRK fusion positive colorectal cancer (Cohort2). 6. Unstable or progressive CNS/leptomeningeal metastases (stable brain metastases ≥1 month, no new/enlarging lesions and off steroids ≥4 weeks may enroll).
- 7. Clinically uncontrolled third-space effusion requiring therapeutic paracentesis/drainage within prior 14 days.
- 8. Prior or current interstitial lung disease (ILD), non-infectious pneumonitis requiring steroids, suspected ILD or severely impaired pulmonary function.
- 9. Severe GI disease including chronic inflammatory bowel disease, bowel obstruction or chronic diarrhea.
- 10. Esophageal stent placement, tracheal stent or esophageal stricture (Cohort1).
- 11. Severe cardiovascular disease:
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- Clinically significant cardiac arrhythmias or 2nd/3rd degree AV block requiring intervention.
- Acute coronary syndrome, heart failure, stroke or grade ≥3 cardiovascular event within 6 months.
- NYHA Class ≥II heart failure (exception: stable NYHA II, LVEF≥50%, no exacerbation ≥6 months after optimized medical treatment, confirmed by cardiologist).
- Uncontrolled hypertension: SBP≥150 mmHg and/or DBP≥100 mmHg. 12. History of GI perforation/fistula within 6 months before first dose, or tumor invading adjacent organs (great vessel/trachea) with high risk of bleeding/fistula.
- 13. History of severe thromboembolism within prior 6 months; known inherited/acquired thrombophilia.
- 14. Other malignancy within past 5 years (exception: cured cervical carcinoma in situ, cutaneous squamous cell carcinoma, basal cell carcinoma, papillary thyroid carcinoma).
- 15. Prior allogeneic hematopoietic stem cell or solid organ transplantation. 16. Prior anti-tumor adverse events not recovered to ≤ Grade1 (NCI-CTCAE v6.0, alopecia and investigator-assessed non-risk toxicities excluded) or not meeting eligibility lab criteria.
About this study
Official title: An Open-label, Multicenter Phase IIa Study to Evaluate the Efficacy and Safety of Injectable ALK-N001 in Patients With Advanced Gastrointestinal Tumors
This open-label, multicenter Phase IIa study is to evaluate the efficacy and safety of injectable ALK-N001 in patients with advanced gastrointestinal tumors, with the primary objective to assess its preliminary efficacy.
- Conditions
- Advanced Gastrointestinal Tumors
- Being tested
- Injectable ALK-N001
- Keywords
- ALK-N001, Advanced Gastrointestinal Tumors, Phase IIa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable ALK-N001Drug
Also called QHL-1618
Injectable ALK-N001 is administered intravenously every 2 weeks (Q2W; 28-day treatment cycle). Two predefined dose levels are available: 37.5 mg/m² (Dose A) and 50 mg/m² (Dose B). Enrollment or suspension of dose groups may be determined by the Safety Review Committee (SRC) based on safety, PK, PD and preliminary anti-tumor activity data.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (ESCC), Dose A (37.5 mg/m²) | Experimental | Participants with advanced esophageal squamous cell carcinoma (ESCC) receive injectable ALK-N001 at 37.5 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. Receives: Drug: Injectable ALK-N001 |
| Cohort 1 (ESCC), Dose B (50 mg/m²) | Experimental | Participants with advanced esophageal squamous cell carcinoma (ESCC) receive injectable ALK-N001 at 50 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. Receives: Drug: Injectable ALK-N001 |
| Cohort 2 (CRC), Dose A (37.5 mg/m²) | Experimental | Participants with advanced colorectal carcinoma (CRC) receive injectable ALK-N001 at 37.5 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. Receives: Drug: Injectable ALK-N001 |
| Cohort 2 (CRC), Dose B (50 mg/m²) | Experimental | Participants with advanced colorectal carcinoma (CRC) receive injectable ALK-N001 at 50 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. Receives: Drug: Injectable ALK-N001 |
| Cohort 3 (Other GI Tumors), Dose A (37.5 mg/m²) | Experimental | Participants with advanced other gastrointestinal tumors receive injectable ALK-N001 at 37.5 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Cohort 3 is exploratory and will be activated only if meaningful anti-tumor signals are observed in concurrent ALK-N001 trials. SRC may adjust enrollment based on safety, PK, PD and efficacy data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. Receives: Drug: Injectable ALK-N001 |
| Cohort 3 (Other GI Tumors), Dose B (50 mg/m²) | Experimental | Participants with advanced other gastrointestinal tumors receive injectable ALK-N001 at 50 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Cohort 3 is exploratory and will be activated only if meaningful anti-tumor signals are observed in concurrent ALK-N001 trials. SRC may adjust enrollment based on safety, PK, PD and efficacy data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. Receives: Drug: Injectable ALK-N001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR), assessed per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as evaluated by RECIST V1.1.
Measured: Up to approximately 24 months from the first dose.
Secondary outcomes (7)
Duration of Response (DOR)
Description: DOR is defined as the time from the first documentation of CR/PR until the first documented progressive disease (PD) or death from any cause.
Measured: Up to approximately 24 months from the first dose.
Disease Control Rate (DCR)
DCR is the proportion of participants achieving CR, PR, or stable disease (SD) per RECIST V1.1.
Time Frame: Up to approximately 24 months from the first dose.
Measured: Up to approximately 24 months from the first dose.
Progression-Free Survival (PFS)
PFS is the time from study enrollment to documented PD or death from any cause. 6-,12-,24-month PFS rates will be calculated.
Measured: Up to approximately 24 months from the first dose.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause. 12-,24-month OS rates will be calculated.
Measured: Up to approximately 24 months from the first dose.
Safety (Adverse Events and Serious Adverse Events)
Incidence, severity and relatedness of AEs and SAEs; laboratory tests, 12-lead ECG, vital signs, physical examination and ECOG performance status.
Measured: From informed consent until 28±7 days after last dose.
Population Pharmacokinetics (PopPK) of total DXD and free DXD
Characterize PopPK profiles of total DXD and free DXD.
Measured: From first dose up to end of treatment.
Exposure-Response (E-R) relationship of total DXD and free DXD
E-R relationship between total/free DXD exposure and efficacy, safety and biomarkers.
Measured: From first dose up to approximately 24 months after first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal TumorsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Anglikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826195
- Sponsor's protocol ID
- ALK-N001-003
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase IIa Study to Evaluate the Efficacy and Safety of Injectable ALK-N001 in Patients With Advanced Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT07826195
- Acronym / sponsor ID
- ALK-N001-003
- Conditions
- Advanced Gastrointestinal Tumors
- Keywords
- ALK-N001, Advanced Gastrointestinal Tumors, Phase IIa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Zhejiang Anglikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Sep 2026 (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 open-label, multicenter Phase IIa study is to evaluate the efficacy and safety of injectable ALK-N001 in patients with advanced gastrointestinal tumors, with the primary objective to assess its preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (ESCC), Dose A (37.5 mg/m²) | Experimental | Drug: Injectable ALK-N001Participants with advanced esophageal squamous cell carcinoma (ESCC) receive injectable ALK-N001 at 37.5 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. |
| Cohort 1 (ESCC), Dose B (50 mg/m²) | Experimental | Drug: Injectable ALK-N001Participants with advanced esophageal squamous cell carcinoma (ESCC) receive injectable ALK-N001 at 50 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. |
| Cohort 2 (CRC), Dose A (37.5 mg/m²) | Experimental | Drug: Injectable ALK-N001Participants with advanced colorectal carcinoma (CRC) receive injectable ALK-N001 at 37.5 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. |
| Cohort 2 (CRC), Dose B (50 mg/m²) | Experimental | Drug: Injectable ALK-N001Participants with advanced colorectal carcinoma (CRC) receive injectable ALK-N001 at 50 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Enrollment and dose expansion may be adjusted by the Safety Review Committee (SRC) based on accumulated safety, PK, PD and preliminary anti-tumor data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. |
| Cohort 3 (Other GI Tumors), Dose A (37.5 mg/m²) | Experimental | Drug: Injectable ALK-N001Participants with advanced other gastrointestinal tumors receive injectable ALK-N001 at 37.5 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Cohort 3 is exploratory and will be activated only if meaningful anti-tumor signals are observed in concurrent ALK-N001 trials. SRC may adjust enrollment based on safety, PK, PD and efficacy data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. |
| Cohort 3 (Other GI Tumors), Dose B (50 mg/m²) | Experimental | Drug: Injectable ALK-N001Participants with advanced other gastrointestinal tumors receive injectable ALK-N001 at 50 mg/m² intravenously every 2 weeks (Q2W) per 28-day cycle. Cohort 3 is exploratory and will be activated only if meaningful anti-tumor signals are observed in concurrent ALK-N001 trials. SRC may adjust enrollment based on safety, PK, PD and efficacy data. Treatment continues until intolerable toxicity, progressive disease, or other discontinuation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Voluntarily sign informed consent, understand the study and be willing and able to comply with all study procedures.
- Age ≥18 years (male or female) at the time of signing informed consent.
- Histologically or cytologically confirmed locally advanced or metastatic esophageal squamous cell carcinoma, colorectal adenocarcinoma, or other gastrointestinal tumors.
- Disease progression or intolerance after prior standard-of-care (SoC) treatment:
- At least one measurable lesion per RECIST V1.1 (lesions in prior radiation field generally not measurable unless clear progression).
Key exclusion criteria (21 listed)
- 1. Received chemotherapy, radiotherapy (palliative local radiotherapy within prior 2 weeks), biotherapy, targeted therapy, immunotherapy, TIL or other anti-tumor therapies within 4 weeks before first dose.
- 2. Use of strong CYP3A4 inducer/inhibitor within 7 days before first dose or planned during study.
- 3. Prior treatment with DXD-containing ADC or PDC. 4. Active infection at screening requiring systemic anti-infective therapy within 2 weeks prior to first dose.
- 5. Known BRAF mutation or NTRK fusion positive colorectal cancer (Cohort2). 6. Unstable or progressive CNS/leptomeningeal metastases (stable brain metastases ≥1 month, no new/enlarging lesions and off steroids ≥4 weeks may enroll).
- 7. Clinically uncontrolled third-space effusion requiring therapeutic paracentesis/drainage within prior 14 days.
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 |
|---|---|---|
| Injectable ALK-N001Also: QHL-1618Injectable ALK-N001 is administered intravenously every 2 weeks (Q2W; 28-day treatment cycle). Two predefined dose levels are available: 37.5 mg/m² (Dose A) and 50 mg/m² (Dose B). Enrollment or suspension of dose groups may be determined by the Safety Review Committee (SRC) based on safety, PK, PD and preliminary anti-tumor activity data. | Drug | Cohort 1 (ESCC), Dose A (37.5 mg/m²), Cohort 1 (ESCC), Dose B (50 mg/m²), Cohort 2 (CRC), Dose A (37.5 mg/m²), Cohort 2 (CRC), Dose B (50 mg/m²), Cohort 3 (Other GI Tumors), Dose A (37.5 mg/m²), Cohort 3 (Other GI Tumors), Dose B (50 mg/m²) |
Primary outcome
Objective Response Rate (ORR), assessed per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to approximately 24 months from the first dose.
ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as evaluated by RECIST V1.1.
7 secondary outcomes
Duration of Response (DOR)
Time frame: Up to approximately 24 months from the first dose.
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months from the first dose.
Progression-Free Survival (PFS)
Time frame: Up to approximately 24 months from the first dose.
Overall Survival (OS)
Time frame: Up to approximately 24 months from the first dose.
Safety (Adverse Events and Serious Adverse Events)
Time frame: From informed consent until 28±7 days after last dose.
Population Pharmacokinetics (PopPK) of total DXD and free DXD
Time frame: From first dose up to end of treatment.
Exposure-Response (E-R) relationship of total DXD and free DXD
Time frame: From first dose up to approximately 24 months after first dose.
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 17 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injectable ALK-N001 in people with Advanced Gastrointestinal Tumors, run by Zhejiang Anglikang Pharmaceutical Co., Ltd..
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 16 inclusion and 21 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
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?
Objective Response Rate (ORR), assessed per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Up to approximately 24 months from the first 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 17 Sep 2026.