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

NCT07590531 | Not Yet Recruiting Phase 1

• 1 other identifier: AMT-116-202
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with ivosidan (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.

Conditions

Advanced Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (4)

• 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

  approximately 10 months

• 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

  approximately 10 months

• 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

  approximately 12 months

• 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

  approximately 12 months

Secondary Outcomes (15)

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

  approximately 10 months

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

  approximately 10 months

• Phase I: Progression-free Survival (PFS)Time

  approximately 10 months

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

  approximately 10 months

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

  approximately 10 months

Study Arms (2)

Phase I: Dose escalation

EXPERIMENTAL

Three dose levels in the Phase I part of the study

Drug: AMT-116; Drug: AK112

Phase II: Dose Expansion

OTHER

Patients in phase II will be enrolled based on the RP2D (Recommended Phase 2 Dose) determined from phase I dose escalation data.

Drug: AMT-116; Drug: AK112

Interventions

AMT-116 DRUG

AMT-116 is an antibody Drug Conjugate (ADC)

Phase I: Dose escalation; Phase II: Dose Expansion

AK112 DRUG

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

Phase I: Dose escalation; Phase II: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• i. 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.
• ii. Received a live or attenuated vaccine within 4 weeks prior to the first dose.
• iii. 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.

Sponsors & Collaborators

• Multitude Therapeutics Inc.: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Juanjuan Zhu

CONTACT

13917933915; juanjuan.zhu@multitudetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (2)