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Advanced Non-small Cell Lung Cancer (NSCLC)Phase 1/2NCT07590531

AMT-116 in Combination With AK112 in Patients With Lung Cancer

A Phase 1/2 study testing AMT-116 and AK112 in people with Advanced Non-small Cell Lung Cancer (NSCLC), run by Multitude Therapeutics Inc. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with Ivonescimab (AK112) in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
AMT-116 and AK112
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
2 sitesChina
Study dates
29 Jun 2026to 31 Dec 2027
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent for this trial.
  • At the time of screening, aged ≥18 years and ≤75 years.
  • Histologically or cytologically confirmed locally advanced (Stage IIIB/III C) or metastatic (Stage IV) NSCLC that is not amenable to complete surgical resection and cannot be treated with curative concurrent or sequential chemoradiotherapy (according to the 8th edition of the International Union Against Cancer and the American Joint Committee on Cancer TNM staging for lung cancer).
  • Stage Ib: Locally advanced/metastatic NSCLC; both subjects who have previously received systemic therapy and those who have not may be enrolled;
  • Phase II: Each cohort must meet the following requirements:
  • Cohort 1: Histologically or cytologically diagnosed with non-squamous NSCLC, EGFR wild-type, and ALK fusion-negative.
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  • Co-hort 2: Histologically or cytologically diagnosed with squamous-cell NSCLC, known to be EGFR wild-type and ALK fusion gene-negative.
  • Co-hort 3: Histologically or cytologically diagnosed with non-squamous NSCLC and harboring an EGFR mutation.
  • Subjects must have at least one measurable lesion (as defined by RECIST 1.1 criteria).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected survival of ≥12 weeks.
  • Subjects' laboratory test results must meet the requirements.
  • Women of child-bearing potential (WCBP) must consent to the use of two effective contraceptive methods during the study treatment period and for at least 12 weeks after the final administration of IMP
  • Women of child-bearing potential (WCBP) must have a negative serum pregnancy test within seven days preceding the initial administration of the investigational medicinal product (IMP).
  • Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.
  • Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.

Who cannot join

  • Histopathological evidence of small cell lung cancer.
  • For Cohort 1 and Cohort 2 of Phase II, patients must not have non-small cell lung cancer with known EGFR-sensitive mutations, ALK fusions, BRAF V600E mutations, ROS1 fusions, MET exon 14 skipping mutations, NTRK fusions, or RET fusions.
  • Prior treatment with any CD44v9-targeted therapy or an antibody-drug conjugate (ADC) based on a topoisomerase I inhibitor as the toxin.
  • Received the following treatments or medications prior to the start of the study:
  • Systemic anticancer therapy, including chemotherapy and biologics, within 3 weeks prior to the first dose; hormonal anticancer therapy or small-molecule targeted therapy within 2 weeks prior to the first dose; or Chinese herbal medicines or proprietary Chinese herbal preparations with anticancer indications within 2 weeks prior to the first dose. Received nonspecific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to the first dose.
  • Received a live or attenuated vaccine within 4 weeks prior to the first dose.
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  • Received radiation therapy within 3 weeks prior to the first dose. Palliative radiation therapy administered for symptom control at least 2 weeks prior to the first dose is permitted.
  • Received systemic immunosuppressive therapy (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to the first dose.
  • Adverse reactions from prior treatment have not yet resolved to Grade 1 or less.
  • Subjects who have experienced an immune-related adverse event (irAE) requiring permanent discontinuation of treatment, or a Grade 3 or higher irAE, or a cardiac, neurological, or ocular irAE of any grade (including Grade 2 immune-related pneumonia, but excluding Grade 3 hypothyroidism that can be controlled with hormone replacement therapy).
  • Known symptomatic brain metastases or other central nervous system (CNS) metastases, or brain metastases or other CNS metastases that the investigator deems to require treatment but have not been treated. Subjects with asymptomatic brain metastases or a history of brain metastases that have been stable for ≥2 weeks prior to the first dose may be eligible for this study, provided they meet all of the following criteria: no metastases to the meninges, midbrain, pons, cerebellum, medulla oblongata, or spinal cord, or spinal cord compression; discontinuation of hormonal therapy for more than 2 weeks prior to the first dose; imaging studies performed within at least 4 weeks show no evidence of new or enlarged brain metastases.
  • History of malignancy other than the enrollment diagnosis within 5 years prior to the first administration of the study drug.
  • Underwent major surgery within 4 weeks prior to the first administration of the study drug, or has not fully recovered from surgery; or sustained a major traumatic injury within 4 weeks prior to the first administration; or is scheduled to undergo surgery during the anticipated duration of study participation or within 4 weeks after the last administration.
  • History of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy; current ILD/pneumonia; suspected ILD/pneumonia (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, etc.); or other pulmonary diseases that significantly impair lung function at baseline.
  • History of active autoimmune disease or a history of autoimmune disease requiring systemic treatment within the past 2 years.
  • Current or past history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • History of hypertensive crisis or hypertensive encephalopathy.
  • Subjects with severe coagulation disorders or other evidence of significant bleeding risk.
  • Uncontrolled pleural effusion or ascites requiring repeated drainage within 4 weeks prior to the first dose.
  • Active infection treated with systemic antimicrobial therapy within 2 weeks prior to the first dose. Severe infection occurring within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
  • History of abdominal fistula, tracheoesophageal fistula, or female genital fistula (e.g., vesicovaginal fistula, ureterovaginal fistula, and vesicovaginal fistula), gastrointestinal perforation, or abdominal abscess; or if the investigator considers the subject to have risk factors for gastrointestinal obstruction. If the fistula or perforation has been treated by resection or repair, and the investigator assesses that the condition has fully resolved, the subject may be enrolled.
  • The subject has uncontrolled comorbidities, including but not limited to poorly controlled hypertension or diabetes, psychiatric disorders, or conditions that may limit study compliance, or other comorbidities or conditions that the investigator believes may affect study judgment or interfere with the completion of study procedures and follow-up examinations.
  • Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.
  • Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies at screening are ineligible for enrollment, unless hepatitis B virus (HBV) DNA levels and HCV RNA testing clearly rule out active infection requiring antiviral treatment for hepatitis B or C (HBV DNA ≥ 1000 cps/mL or 200 IU/mL).
  • Known active tuberculosis (TB); suspected active tuberculosis must be ruled out by clinical examination.
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, excluding corneal transplantation.
  • Known immediate-type or delayed-type hypersensitivity to the study drug, a history of allergic reactions, or allergy to any component of the study drug or excipients.
  • Pregnancy (positive β-human chorionic gonadotropin [β-hCG] test) and lactating women.
  • The subject is unwilling or unable to comply with the protocol.
  • The subject requires the use of a potent CYP3A4 inhibitor within one week prior to dosing or during the study.
  • Any other disease, metabolic disorder, physical examination findings, or clinical laboratory results that raise suspicion of contraindications to the study drug, or that may affect the subject's safety, the interpretation of study results, or place the subject at high risk of complications.
  • -

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Juanjuan Zhu contact

13917933915

juanjuan.zhu@multitudetherapeutics.com

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Li Zhang

    Not yet recruiting

  • Zhejiang cancer hospital

    Hangzhou, Zhejiang

    Zhengbo Song, songzb@zjcc.org.cn

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter Phase Ib/II Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMT116 in Combination With Ivonescimab (AK112) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with Ivonescimab (AK112) in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.

Being tested
AMT-116, AK112

What participants receive

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

  • AMT-116Drug

    AMT-116 is an antibody Drug Conjugate (ADC)

  • AK112Drug

    AK112 is a PD-1/VEGF bispecific tumor immunotherapy drug

Study groups in NCT07590531
Study groupRoleWhat they receive
Phase I: Dose escalationExperimentalThree dose levels in the Phase I part of the study
Receives: Drug: AMT-116; Drug: AK112
Phase II: Dose ExpansionOtherPatients in phase II will be enrolled based on the RP2D (Recommended Phase 2 Dose) determined from phase I dose escalation data.
Receives: Drug: AMT-116; Drug: AK112

What is being measured

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

  1. Phase I: To evaluate the safety and tolerability of the combination of AMT-116 and AK112 in patients with advanced NSCLC and to determine the recommended Phase 2 dose (RP2CD)

    The MTD（Maximum Tolerated Dose） and RP2CD（Recommended Phase 2 Dose） will be determined for expansion using dose limiting toxicities (DLTs) and all other available study data

    Measured: approximately 10 months

  2. Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs)

    Assess safety and tolerability of AMT-116 and AK112 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

    Measured: approximately 10 months

  3. Phase II: Objective Response Rate(ORR)

    To evaluate the objective response rate (ORR) [Complete Response (CR) + Partial Response (PR)] according to the RECIST v1.1

    Measured: approximately 12 months

  4. Phase II: Type, incidence and severity of Adverse Events

    Assess safety and tolerability of AMT-116 and AK112 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

    Measured: approximately 12 months

Secondary outcomes (15)

  1. Phase I: Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Proportion of patients achieving Complete Response (CR) or Partial Response (PR)

    Measured: approximately 10 months

  2. Phase I: Disease Control Rate (DCR) according to the RECIST v1.1

    Proportion of patients achieving CR, PR or Stable Disease (SD)

    Measured: approximately 10 months

  3. Phase I: Progression-free Survival (PFS)Time

    Time from date of start of treatment to date of the first progression or death

    Measured: approximately 10 months

  4. Phase I: Levels of target expression or Tumor Infiltrating Lymphocyte in tumor tissue

    To assess levels of target expression and Tumor Infiltrating Lymphocyte in tumor tissue

    Measured: approximately 10 months

  5. Phase I: Concentration of anti-drug antibodies (ADA)

    Immunogenicity profile characterized by concentration of ADAs

    Measured: approximately 10 months

  6. Phase I: Maximum observed concentration (C[max])

    Pharmacokinetic profile characterized by the maximum observed concentration

    Measured: approximately 10 months

  7. Phase I: Maximum observed concentration (C[max])

    To characterize the PK profile by analyzing maximum observed

    Measured: approximately 10 months

  8. Phase II: Disease Control Rate (DCR) according to the RECIST v1.1

    Proportion of patients achieving CR, PR or Stable Disease (SD)

    Measured: approximately 12 months

  9. Phase II: Progression-free Survival (PFS) according to RECIST v1.1

    Time from date of start of treatment to date of the first progression or death, whichever occurs first.

    Measured: approximately 12 months

  10. Phase II: Duration of response (DOR)

    DOR is defined as the time from the date of first documented CR or PR to PD or death

    Measured: approximately 12 months

  11. Phase II: Time to response(TTR)

    The time from the start date of treatment to the date of the first response assessment (PR or CR)

    Measured: approximately 12 months

  12. Phase II: Levels of target expression in tumor tissue

    To assess levels of target expression in tumor tissue and correlation of those levels with responses and toxicity.

    Measured: approximately 12months

  13. Phase II: Percentage of patients with ADA formation

    To obtain Percentage of patients with ADA formation

    Measured: approximately 12 months

  14. Phase II: Maximum observed concentration (C[max])

    To characterize the PK profile by analyzing maximum observed

    Measured: approximately 12 months

  15. Phase II: Area under the curve (AUC)

    To characterize the PK profile by analyzing area under the curve (AUC) of the ADC, total antibody, and free payload.

    Measured: approximately 12 months

Timeline

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

  1. First posted15 May 2026
  2. Study start29 Jun 2026
  3. Primary completion30 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Sequential
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07590531
Sponsor's protocol ID
AMT-116-202
Status last verified
Jul 2026
First submitted
10 May 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMT-116 and AK112 in people with Advanced Non-small Cell Lung Cancer (NSCLC), run by Multitude Therapeutics Inc. at 2 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 16 inclusion and 32 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 10 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 2 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?

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 Juanjuan Zhu (13917933915, juanjuan.zhu@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: To evaluate the safety and tolerability of the combination of AMT-116 and AK112 in patients with advanced NSCLC and to determine the recommended Phase 2 dose (RP2CD) (time frame: approximately 10 months). The study lists 4 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 NCT07590531.

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 Aug 2026.

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