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Cancer Vaccine

AMT-116 for Cancer

Phase 1
Recruiting
Led By Jermaine Coward
Research Sponsored by Multitude Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Age ≥18 years (at the time consent is obtained).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safe and effective dose of a new drug called AMT-116 in patients with advanced solid tumors. The study will also look at how the drug is processed in the body,

Who is the study for?
This trial is for adults over 18 with advanced solid tumors who've tried at least one systemic therapy and have no standard treatment options left, or can't tolerate them. They should have a measurable tumor, be in good physical condition (ECOG 0-1), and agree to use contraception. It's not specified who cannot join.
What is being tested?
AMT-116 is being tested to find the highest dose patients can take without serious side effects (MTD/RP2D). The study will also look at how safe it is, how well it works against cancer, how the body processes it, and if it causes any immune reactions.
What are the potential side effects?
Specific side effects of AMT-116 are not listed but may include typical reactions seen with cancer treatments such as fatigue, nausea, inflammation in organs or infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced cancer that cannot be removed by surgery.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I am a male and agree to use a condom during the study and for 12 weeks after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Type, incidence and severity of Adverse Events
Secondary study objectives
Area under the curve (AUC)
Concentration of anti-drug antibodies (ADA)
Disease Control Rate (DCR) according to the RECIST v1.1
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AMT-116 Dose EscalationExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Multitude Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
200 Total Patients Enrolled
Jermaine CowardPrincipal InvestigatorICON Cancer Centre
2 Previous Clinical Trials
90 Total Patients Enrolled
~0 spots leftby Jan 2025
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