Advanced Solid TumorsPhase 1/2NCT06782334
AMT-116 in Patients with Solid Tumors
A Phase 1/2 study testing AMT-116 in people with Advanced Solid Tumors, run by Multitude Therapeutics Inc. at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AMT-116
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 7 sitesChina
- Study dates
- 7 May 2024to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
- Age ≥18 years (at the time consent is obtained).
- 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.
- 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.
- Patients must have at least one measurable lesion as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Show all 13Show fewer
- The anticipated survival duration is no less than three months.
- Patients must have adequate organ function
- 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.
- Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.
Who cannot join
- Prior therapy with ADC based on Top1 inhibitor.
- Central nervous system (CNS) metastasis.
- Active or chronic skin disorder requiring systemic therapy.
- History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
- 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.
- Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
Show all 22Show fewer
- Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
- 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.
- 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.
- 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.
- 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.).
- 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.
- 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).
- Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
- 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.
- Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
- Known or suspected intolerance to the components of the IMP.
- Concurrent participation in another investigational therapeutic clinical trial.
- Patients with known active alcohol or drug abuse.
- Pregnant or breast-feeding females.
- 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.
- There was a history of malignant tumors other than the selected diagnosis within 5 years prior to the first administration of IMP
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
- Not yet recruiting
Dongguan People's Hospital
Dongguan, Guangdong
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
- Recruiting
Zhujiang Hospital of Southern Medical University(The Second Clinical Medical College)
Guangzhou, Guangdong
- Recruiting
Zhejiang cancer hospital
Hangzhou, Zhejiang
Zhengbo Song
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
- Recruiting
The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: Phase 1/2 Study of AMT-116 in Patients with Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- AMT-116
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)
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose escalation | Experimental | Five dose levels in the Phase I part of the study Receives: Drug: AMT-116 |
| 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. Receives: Drug: AMT-116 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 12 months
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
Measured: approximately 12 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
Measured: approximately 18 months
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
Measured: approximately 18 months
Secondary outcomes (19)
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 12 months
Phase I Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Measured: approximately 12 months
Phase I: Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first
Measured: approximately 12 months
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 12 months
Phase I: Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Measured: approximately 12 months
Phase I: Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-116
Measured: approximately 12 months
Phase I: Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-116
Measured: approximately 12 months
Phase I: Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-116
Measured: approximately 12 months
Phase I: Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-116
Measured: approximately 12 months
Phase II: Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Measured: approximately 18 months
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 18 months
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.
Measured: approximately 18 months
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 18 months
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 18 months
Phase II: Percentage of patients with ADA formation to AMT-116.
To obtain Percentage of patients with ADA formation to AMT-116
Measured: approximately 18 months
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.
Measured: approximately 18 months
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.
Measured: approximately 18 months
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.
Measured: approximately 18 months
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.
Measured: approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start7 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multitude Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782334
- Sponsor's protocol ID
- AMT-116-02
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of AMT-116 in Patients with Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06782334
- Acronym / sponsor ID
- AMT-116-02
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Multitude Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose escalation | Experimental | Drug: AMT-116Five dose levels in the Phase I part of the study |
| Phase II: Dose Expansion | Other | Drug: AMT-116Patients in phase II will be enrolled based on the RP2D (Recommended Phase 2 Dose) determined from phase I dose escalation data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
- Age ≥18 years (at the time consent is obtained).
- 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.
- 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.
- Patients must have at least one measurable lesion as per RECIST version 1.1.
Key exclusion criteria (22 listed)
- Prior therapy with ADC based on Top1 inhibitor.
- Central nervous system (CNS) metastasis.
- Active or chronic skin disorder requiring systemic therapy.
- History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
- 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.
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 |
|---|---|---|
| AMT-116AMT-116 is an antibody Drug Conjugate (ADC) | Drug | Phase I: Dose escalation, Phase II: Dose Expansion |
Primary outcome
Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116
Time frame: approximately 12 months
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
Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs)
Time frame: approximately 12 months
Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0
Phase II: Objective Response Rate(ORR)
Time frame: approximately 18 months
To evaluate the objective response rate (ORR) [Complete Response (CR) + Partial Response (PR)] according to the RECIST v1.1
Phase II: Type, incidence and severity of Adverse Events
Time frame: approximately 18 months
Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0
19 secondary outcomes
Phase I: Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: approximately 12 months
Phase I Disease Control Rate (DCR) according to the RECIST v1.1
Time frame: approximately 12 months
Phase I: Progression-free Survival (PFS)
Time frame: approximately 12 months
Phase I: Levels of target expression or Tumor Infiltrating Lymphocyte in tumor tissue
Time frame: approximately 12 months
Phase I: Concentration of anti-drug antibodies (ADA)
Time frame: approximately 12 months
Phase I: Maximum observed concentration (C[max])
Time frame: approximately 12 months
Phase I: Area under the curve (AUC)
Time frame: approximately 12 months
Phase I: Terminal half-life (t[1/2])
Time frame: approximately 12 months
Phase I: Time to maximum concentration (Tmax)
Time frame: approximately 12 months
Phase II: Disease Control Rate (DCR) according to the RECIST v1.1
Time frame: approximately 18 months
Phase II: Progression-free Survival (PFS) according to RECIST v1.1
Time frame: approximately 18 months
Phase II: Duration of response (DOR)
Time frame: approximately 18 months
Phase II: Time to response(TTR)
Time frame: approximately 18 months
Phase II: Levels of target expression in tumor tissue
Time frame: approximately 18 months
Phase II: Percentage of patients with ADA formation to AMT-116.
Time frame: approximately 18 months
Phase II: Maximum observed concentration (C[max])
Time frame: approximately 18 months
Phase II: Area under the curve (AUC)
Time frame: approximately 18 months
Phase II: Terminal half-life (t[1/2])
Time frame: approximately 18 months
Phase II: Time to maximum concentration (Tmax)
Time frame: approximately 18 months
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 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMT-116 in people with Advanced Solid Tumors, run by Multitude Therapeutics Inc. at 7 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 13 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Yixuan Wang (+86-021-33560023, yixuan.wang@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116 (time frame: approximately 12 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?
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 Jan 2025.