Advanced Solid TumorPhase 1NCT05725291
AMT-116 in Patients With Advanced Solid Tumors
A Phase 1 study testing AMT-116 in people with Advanced Solid Tumor, run by Multitude Therapeutics Inc. at 10 sites in 3 countries.
Trial summary
This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- AMT-116
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 25 Jul 2023to 30 Dec 2026
- Phase
- Phase 1
- 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 head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, 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 12Show fewer
- Both male and female patients must agree to use effective contraceptive methods.
- Patients must have adequate organ function.
- Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
- 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 13Show 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.
- Prior allogeneic or autologous bone marrow transplantation.
- 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.
- Pregnant or breast-feeding females.
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
Australia6 sites, 6 recruiting
- Recruiting
Southern Oncology Clinical Research Unit
Adelaide, South Australia, 5042
Kichenadasse Ganessan
- Recruiting
ICON Cancer Centre
Brisbane, Queensland
Jermaine Coward
- Recruiting
Macquarie University Hospital
Sydney, New South Wales, 2109
Park John
- Recruiting
Alfred Hospital
Victoria Park, Victoria, 3004
Voskoboynik Mark
- Recruiting
Austin Health
Victoria Park, Victoria, 3084
Parakh Sagun
- Recruiting
Cabrini Hospital
Victoria Park, Victoria, 3144
Richardson Gary
United States2 sites, 2 recruiting
- Recruiting
Mary Crowley Cancer Research Centers
Dallas, Texas, 75230
Orr Douglas
- Not yet recruiting
Sarah Cannon Research Institute
Denver, Colorado, 80218
Perez Batista Cesar Augusto
American Samoa2 sites, 2 recruiting
- Recruiting
Carolina BioOncology Institute, LLC
Cary, North Carolina, 28078
Powderly John
- Not yet recruiting
University of California San Francisco Cancer Center
San Francisco, California, 94115
Munster Pamela
About this study
Official title: First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors
This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in Patients with Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- 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
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| AMT-116 Dose Escalation | Experimental | Not described Receives: Drug: AMT-116 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Measured: Up to 24 months
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Measured: Up to 24 months
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Measured: Up to 24 months
Secondary outcomes (8)
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: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Measured: Up to 24 months
Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Measured: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Measured: Up to 24 months
Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-116
Measured: Up to 24 months
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-116
Measured: Up to 24 months
Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-116
Measured: Up to 24 months
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-116
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start25 Jul 2023
- Primary completion30 Dec 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 TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multitude Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jermaine Coward, Principal investigator, Integrated Haematology and Oncology Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725291
- Sponsor's protocol ID
- AMT-116-01
- Status last verified
- Aug 2025
- First submitted
- 2 Feb 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05725291
- Acronym / sponsor ID
- AMT-116-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Multitude Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Feb 2023 (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 first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in Patients with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMT-116 Dose Escalation | Experimental | Drug: AMT-116 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, 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 (13 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-116Administered intravenously | Drug | AMT-116 Dose Escalation |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 24 months
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Maximum Tolerated Dose (MTD)
Time frame: Up to 24 months
The MTD will be determined using DLTs
Type, incidence and severity of Adverse Events
Time frame: Up to 24 months
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
8 secondary outcomes
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Time frame: Up to 24 months
Progression-free Survival (PFS)
Time frame: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Time frame: Up to 24 months
Maximum observed concentration (C[max])
Time frame: Up to 24 months
Area under the curve (AUC)
Time frame: Up to 24 months
Terminal half-life (t[1/2])
Time frame: Up to 24 months
Time to maximum concentration (Tmax)
Time frame: Up to 24 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 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
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.
Jermaine Coward principal investigator
Integrated Haematology and Oncology Network
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMT-116 in people with Advanced Solid Tumor, run by Multitude Therapeutics Inc. at 10 sites in 3 countries.
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 12 inclusion and 13 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 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, United States, American Samoa. 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 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.
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 (+86 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?
Recommended Phase 2 Dose (RP2D) (time frame: Up to 24 months). The study lists 3 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 Aug 2025.