What side effects are associated with this type of intervention?

Common side effects of treatments similar to Tusamitamab Ravtansine, which is an antibody-drug conjugate (ADC), include infusion-related reactions, fatigue, nausea, neutropenia, thrombocytopenia, and peripheral neuropathy. These side effects result from the combined targeted action of the monoclonal antibody and the cytotoxic effects of the drug delivered to the cancer cells.

What prior FDA approvals exist?

The FDA has approved several antibody-drug conjugates (ADCs) for the treatment of various tumors. Examples include Trastuzumab emtansine (Kadcyla) for HER2-positive breast cancer, which combines the HER2-targeting properties of trastuzumab with the cytotoxic agent DM1. Another example is Brentuximab vedotin (Adcetris), approved for Hodgkin lymphoma and systemic anaplastic large cell lymphoma, which targets CD30 and delivers the cytotoxic agent MMAE. These ADCs work by specifically targeting cancer cells and delivering potent cytotoxic agents directly to them, similar to the mechanism of action being studied for Tusamitamab Ravtansine.

What other types of research exist?

Promising novel alternatives to Tusamitamab Ravtansine for tumor patients in 2024 include: 1) Trastuzumab Deruxtecan (Enhertu), an ADC targeting HER2-positive cancers, showing efficacy in breast, gastric, and other cancers. 2) Sacituzumab Govitecan (Trodelvy), an ADC targeting Trop-2, effective in triple-negative breast cancer and urothelial cancer. 3) Enfortumab Vedotin (Padcev), an ADC targeting Nectin-4, used in urothelial carcinoma. 4) Datopotamab Deruxtecan, an ADC targeting TROP2, in trials for non-small cell lung cancer and breast cancer. These therapies have demonstrated significant clinical benefits and are in advanced stages of clinical development or already approved for certain indications.

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Monoclonal Antibodies

Tusamitamab Ravtansine for Metastatic Cancer (TusaRav-QT Trial)

Phase 1

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC) adenocarcinoma, nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GC/GEJ) adenocarcinoma, metastatic disease at study entry

Capable of giving signed informed consent

Must not have

Active infection with hepatitis A, B, or C

Unresolved corneal disorder or any previous corneal disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an experimental drug called tusamitamab ravtansine for patients with advanced colorectal, lung, or stomach/esophagus cancer who have no other treatment options. The drug works by attaching to cancer cells and releasing a toxin to destroy them.

Who is the study for?

This trial is for adults with metastatic colorectal, non-squamous non-small cell lung, or gastric/gastroesophageal junction cancers without standard treatment options. Participants must have measurable disease and be in good physical condition (ECOG 0-1). They should agree to use effective contraception and not have any significant illnesses or unresolved treatment-related toxicities that could affect their participation.

What is being tested?

The study tests Tusamitamab Ravtansine's effect on the heart's electrical activity (QTc interval) in patients with specific advanced solid tumors. It's an open-label, single-arm Phase 1 trial conducted across multiple centers internationally, focusing on those who've exhausted other treatments.

What are the potential side effects?

While specific side effects of Tusamitamab Ravtansine are not listed here, common side effects for cancer drugs like this may include nausea, fatigue, diarrhea, liver problems and potential heart issues such as changes in the QTc interval which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of advanced cancer in the colon, lung, or stomach.

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I am able to understand and sign the consent form.

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My tumor expresses CEACAM5.

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I am fully active or can carry out light work.

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My lung cancer shows CEACAM5 presence or high CEA levels if no tumor tissue is available.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active hepatitis A, B, or C infection.

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I have an ongoing or past eye cornea problem.

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My bone marrow, liver, kidney functions, or electrolyte levels are not normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Duration of response (DOR)

ECG parameter: PR interval

ECG parameter: QRS interval

+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: Tusamitamab ravtansineExperimental Treatment1 Intervention

Participants will receive tusamitamab ravtansine intravenous (IV) infusion until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibody-drug conjugates (ADCs) like Tusamitamab Ravtansine work by combining a monoclonal antibody specific to cancer cell antigens with a potent cytotoxic drug. The antibody component targets and binds to antigens on the surface of cancer cells, allowing the cytotoxic drug to be delivered directly into the cancer cells, thereby minimizing damage to healthy cells. This targeted approach is significant for tumor patients as it enhances treatment efficacy and reduces side effects compared to traditional chemotherapy. Other common treatments include chemotherapy, which kills rapidly dividing cells; radiation therapy, which damages DNA in cancer cells; and immunotherapy, which boosts the body's immune response against cancer cells. Each of these treatments has unique mechanisms that contribute to their effectiveness in managing tumors.