Forimtamig for Multiple Myeloma

Recruiting at 37 trial locations

Overseen By Reference Study ID Number: BP42233 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Must be taking: Immunomodulatory, Proteasome inhibitors

Must not be taking: Monoclonal antibodies, Immunotherapeutics

Disqualifiers: Pregnancy, Auto-immune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

225 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called Forimtamig on patients with a type of cancer called multiple myeloma. These patients have no other treatment options or cannot tolerate existing treatments. The drug aims to either kill the cancer cells or help the immune system fight them.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as monoclonal antibodies, immunotherapeutic agents, and other anti-cancer treatments, at least 2 weeks before starting the study drug. However, limited field palliative radiotherapy for bone pain or soft tissue lesions is allowed.

What data supports the effectiveness of the drug RO7425781 for treating multiple myeloma?

Research shows that new treatments for multiple myeloma, like immunotherapy and proteasome inhibitors, have improved patient outcomes significantly. These treatments, which include drugs similar to RO7425781, have shown to provide lasting benefits and manageable side effects. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with relapsed or refractory Multiple Myeloma who've tried other treatments like IMiDs and PIs but can't use them anymore. They should have a life expectancy of at least 12 weeks, measurable disease, and be willing to follow birth control guidelines. People can't join if they're pregnant, breastfeeding, recently used certain cancer drugs or immunotherapies, had organ transplants, active autoimmune diseases, or stem cell transplantation within the last 100 days.

Inclusion Criteria

I agree to provide tissue samples for the study.

I have relapsed/refractory multiple myeloma and cannot tolerate or have no other standard treatments left.

I have been diagnosed with Multiple Myeloma.

Exclusion Criteria

I haven't taken any antibody treatments for my MM in the last 2 weeks.

I haven't taken any immune system treatments in the last 2 weeks.

I had a stem cell transplant within the last 100 days or have ongoing signs of graft versus host disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of forimtamig via IV infusion and/or SC injection

Varies

Dose Expansion

Participants receive forimtamig at the Recommended Phase 2 Doses (RP2Ds) determined in the Dose Escalation phase

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• RO7425781

Trial Overview The study tests escalating doses of Forimtamig in two parts: first finding the right dose (Part 1) and then giving that dose to more people to see how well it works (Part 2). It's for patients with no standard treatment options left or those intolerant to existing therapies.

Participant Groups

Group I: Part II: Dose Expansion Experimental Treatment 1 Intervention

Dose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.

Group II: Part I: Dose Escalation Experimental Treatment 1 Intervention

Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Novel agents like immunomodulatory drugs (IMiDs) and proteasome inhibitors (such as bortezomib) have significantly improved treatment outcomes for myeloma, showing better responses when used in combination with steroids and chemotherapy.

These therapies, initially used for relapsed or refractory myeloma, are now being tested in newly diagnosed patients, leading to higher response rates and longer-lasting effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapies for multiple myeloma. Dingli, D., Rajkumar, SV.[2009]

In a phase Ib study involving 31 patients with relapsed/refractory multiple myeloma, the combination of oprozomib, pomalidomide, and dexamethasone showed a promising overall response rate of 70.6%.

While the treatment was generally well-tolerated, common adverse events included gastrointestinal issues like diarrhea and nausea, and hematologic effects such as anemia and neutropenia, indicating that the safety profile of the oprozomib formulation needs improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oprozomib, pomalidomide, and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma. Shah, J., Usmani, S., Stadtmauer, EA., et al.[2020]

Recent advancements in anti-myeloma treatments, including thalidomide, lenalidomide, and bortezomib, have shown significant clinical responses, especially in patients who do not respond to traditional chemotherapy.

The review highlights the ongoing development of various novel therapeutic classes, such as second-generation proteasome inhibitors and HDAC inhibitors, which are currently in clinical trials or advanced preclinical stages, indicating a promising expansion of treatment options for myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the bench to the bedside: emerging new treatments in multiple myeloma. Mitsiades, CS., Hayden, PJ., Anderson, KC., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Emerging therapies for multiple myeloma. [2009]

2. England pubmed.ncbi.nlm.nih.gov

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of multiple myeloma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Oprozomib, pomalidomide, and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

From the bench to the bedside: emerging new treatments in multiple myeloma. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Carfilzomib and pomalidomide: recent advances in the treatment of multiple myeloma. [2014]