Malignant MelanomaPhase 1/2NCT06209580
AMT-253 in Patients With Advanced Solid Tumours
A Phase 1/2 study testing AMT-253 for injection in people with Malignant Melanoma and Advanced Solid Tumors, run by Multitude Therapeutics Inc. at 1 site in China.
Trial summary
This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Advanced Solid Tumors
- What is being tested?
- AMT-253 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 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
- 1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
- 2. Patients with histologically confirmed melanoma or other advanced solid tumor.
- 3. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
- 4. Patients must have at least one measurable lesion as per RECIST version 1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 6. Life expectancy ≥ 3 months.
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- 7. Patients must have adequate organ function
- 8. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.
- 9. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
- 10. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.
- 11. 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.
- 12. Availability of tumor tissue sample at screening.
Who cannot join
- 1. Prior treatment with any agent that has the same target.
- 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. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
- 6. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
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- 7. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
- 8. Significant cardiac disease, such as recent myocardial infarction or acute coronary syndromes, congestive heart failure， uncontrolled hypertension, uncontrolled cardiac arrhythmias.
- 9. 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.
- 10. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
- 11. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Guo, 86-010-88121122
About this study
Official title: Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors
This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.
- Conditions
- Malignant Melanoma, Advanced Solid Tumors
- Being tested
- AMT-253 for injection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-253 for injectionDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | AMT-253 Dose Escalation Receives: Drug: AMT-253 for injection |
| Arm 2 | Experimental | AMT-253 Dose Expansion Receives: Drug: AMT-253 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Incidence of dose limiting toxicities
Measured: 21 days after first dose
AEs
Type, incidence and severity of Adverse Events
Measured: Up to 24 months
SAEs
Type, incidence and severity Serious Adverse Events (SAEs)
Measured: Up to 24 months
ORR
Overall response rate assessed by the investigator according to RECIST version 1.1
Measured: Up to 24 months
Secondary outcomes (5)
Cmax
aximum concentration (Cmax)
Measured: Up to 24 months
Tmax
time to peak drug concentration
Measured: Up to 24 months
AUC
Area Under the Curve
Measured: Up to 24 months
t1/2
terminal half-life of the ADC, total antibody and free payload
Measured: Up to 24 months
ADAs
Specification and quantification of anti-drug antibodies
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 posted17 Jan 2024
- Study start31 Jan 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 96 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
- NCT06209580
- Sponsor's protocol ID
- AMT-253-02
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06209580
- Acronym / sponsor ID
- AMT-253-02
- Conditions
- Malignant Melanoma, Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Multitude Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jan 2024 (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 is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AMT-253 for injectionAMT-253 Dose Escalation |
| Arm 2 | Experimental | Drug: AMT-253 for injectionAMT-253 Dose Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
- 2. Patients with histologically confirmed melanoma or other advanced solid tumor.
- 3. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
- 4. Patients must have at least one measurable lesion as per RECIST version 1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (11 listed)
- 1. Prior treatment with any agent that has the same target.
- 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. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
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-253 for injectionAdministered intravenously | Drug | Arm 1, Arm 2 |
Primary outcome
DLTs
Time frame: 21 days after first dose
Incidence of dose limiting toxicities
AEs
Time frame: Up to 24 months
Type, incidence and severity of Adverse Events
SAEs
Time frame: Up to 24 months
Type, incidence and severity Serious Adverse Events (SAEs)
ORR
Time frame: Up to 24 months
Overall response rate assessed by the investigator according to RECIST version 1.1
5 secondary outcomes
Cmax
Time frame: Up to 24 months
Tmax
Time frame: Up to 24 months
AUC
Time frame: Up to 24 months
t1/2
Time frame: Up to 24 months
ADAs
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 5 Sep 2025.
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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.
1 site 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-253 for injection in people with Malignant Melanoma and Advanced Solid Tumors, run by Multitude Therapeutics Inc. at 1 site 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 12 inclusion and 11 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Minqi Guan (86-15895820062, minqi.guan@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (time frame: 21 days after first dose). 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 5 Sep 2025.