CClinicalTrials.gg
Sign In
RecruitingNCT06782334Updated Jan 17, 2025

AMT-116 in Patients with Solid Tumors

A Phase 1/2 interventional study of AMT-116 in Advanced Solid Tumors, sponsored by Multitude Therapeutics Inc.. Recruiting at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Multitude Therapeutics Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled May 2024, registered Dec 2024).
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
144
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.

02

Conditions studied

  • Advanced Solid Tumors

Browse trials for

03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 144 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Multitude Therapeutics Inc. is the lead sponsor of 8 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
  2. Age ≥18 years (at the time consent is obtained).
  3. Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.
  4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
  5. Patients must have at least one measurable lesion as per RECIST version 1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  7. The anticipated survival duration is no less than three months.
  8. Patients must have adequate organ function
  9. 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
  10. 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).
  11. 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.
  12. 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.
  13. Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Exclusion criteria

Exclusion Criteria:

  1. Prior therapy with ADC based on Top1 inhibitor.
  2. Central nervous system (CNS) metastasis.
  3. Active or chronic skin disorder requiring systemic therapy.
  4. History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
  5. Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.
  6. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
  7. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
  8. Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.
  9. Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.
  10. Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.
  11. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.).
  12. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
  13. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV).
  14. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
  15. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment.
  16. Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
  17. Known or suspected intolerance to the components of the IMP.
  18. Concurrent participation in another investigational therapeutic clinical trial.
  19. Patients with known active alcohol or drug abuse.
  20. Pregnant or breast-feeding females.
  21. Mental or medical disorders that prevent patients from signing informed consent or complying with the study, or other severe acute or chronic medical or psychiatric disorders or abnormal laboratory results that may increase the risk associated with study participation or IMP administration or may interfere with the interpretation of study results and, in the investigator's judgment, make patients ineligible for enrollment in the study.
  22. There was a history of malignant tumors other than the selected diagnosis within 5 years prior to the first administration of IMP
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Phase I: Dose escalation

    Five dose levels in the Phase I part of the study

    Drug: AMT-116

  • Other
    Phase II: Dose Expansion

    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

Interventions

  • DrugAMT-116

    AMT-116 is an antibody Drug Conjugate (ADC)

06

What researchers measure

Primary outcomes

  1. Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116

    The MTD（Maximum Tolerated Dose） and RP2D（Recommended Phase 2 Dose） will be determined for expansion using dose limiting toxicities (DLTs) and all other available study data

    Time frame: approximately 12 months

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

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

    Time frame: approximately 12 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

    Time frame: approximately 18 months

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

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

    Time frame: approximately 18 months

Secondary outcomes

  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)

    Time frame: approximately 12 months

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

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

    Time frame: approximately 12 months

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

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

    Time frame: approximately 12 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

    Time frame: approximately 12 months

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

    Immunogenicity profile characterized by concentration of ADAs

    Time frame: approximately 12 months

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

    Pharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of AMT-116

    Time frame: approximately 12 months

  7. Phase I: Area under the curve (AUC)

    Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-116

    Time frame: approximately 12 months

  8. Phase I: Terminal half-life (t[1/2])

    Pharmacokinetic profile characterized by the terminal half-life (t\[1/2\]) of AMT-116

    Time frame: approximately 12 months

  9. Phase I: Time to maximum concentration (Tmax)

    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-116

    Time frame: approximately 12 months

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

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

    Time frame: approximately 18 months

  11. 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.

    Time frame: approximately 18 months

  12. 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 due to any cause, whichever occurs first.

    Time frame: approximately 18 months

  13. 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)

    Time frame: approximately 18 months

  14. 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.

    Time frame: approximately 18 months

  15. Phase II: Percentage of patients with ADA formation to AMT-116.

    To obtain Percentage of patients with ADA formation to AMT-116

    Time frame: approximately 18 months

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

    To characterize the PK profile of AMT-116 by analyzing maximum observed concentration (C\[max\]) of the ADC, total antibody, and free payload.

    Time frame: approximately 18 months

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

    To characterize the PK profile of AMT-116 by analyzing area under the curve (AUC) of the ADC, total antibody, and free payload.

    Time frame: approximately 18 months

  18. Phase II: Terminal half-life (t[1/2])

    To characterize the PK profile of AMT-116 by analyzing the pharmacokinetic parameter Terminal half-life (t½ )of the ADC, total antibody, and free payload.

    Time frame: approximately 18 months

  19. Phase II: Time to maximum concentration (Tmax)

    To characterize the PK profile of AMT-116 by analyzing the pharmacokinetic parameter time to maximum concentration (Tmax) of the ADC, total antibody, and free payload.

    Time frame: approximately 18 months

07

Study locations

6 of 7 sites recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian, China
    Recruiting
  • Dongguan People's Hospital
    Dongguan, Guangdong, China
    Not yet recruiting
  • Zhujiang Hospital of Southern Medical University(The Second Clinical Medical College)
    Guangzhou, Guangdong, China
    Recruiting
  • Guangxi Medical University Cancer Hospital
    Nanning, Guangxi, China
    Recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan, China
    Recruiting
  • Zhejiang cancer hospital
    Hangzhou, Zhejiang, China
    • Zhengbo Song · Contact
    Recruiting
  • The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06782334
Lead sponsor
Multitude Therapeutics Inc.
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
May 7, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jan 17, 2025

Study contacts

Yixuan Wang
Contact
yixuan.wang@multitudetherapeutics.com
+86-021-33560023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Multitude Therapeutics Inc.

Start the discussion