Forimtamig for Multiple Myeloma

Not currently recruiting at 42 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called forimtamig (also known as RO7425781) for individuals with multiple myeloma, a type of blood cancer, who can no longer use standard treatments. The study aims to determine the best dose and assess how the body processes the treatment. It is open to those who have tried other treatments, such as immunomodulatory drugs and proteasome inhibitors, but have no remaining options. Participants should be prepared to provide biopsy samples and can expect the treatment to be administered by IV or injection. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that forimtamig, a new treatment, is undergoing safety testing in people with multiple myeloma, a type of blood cancer. Earlier studies indicate that forimtamig targets specific cells linked to this cancer. While detailed safety information is still being collected, early results focus on how the body processes the drug and its initial effects. The study aims to find the safest dose and check for any side effects. As this treatment is in an early trial phase, researchers closely monitor it to assess tolerance and identify any negative reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Unlike the standard treatments for multiple myeloma, which often involve chemotherapy, stem cell transplants, and proteasome inhibitors, forimtamig is unique because it employs a novel antibody-based approach. This new treatment, RO7425781, is administered through both intravenous and subcutaneous methods, offering flexibility in how it's delivered. Researchers are excited because forimtamig targets specific proteins on myeloma cells, potentially leading to more precise attacks on cancer cells with fewer side effects. This could mean a more effective treatment with improved quality of life for patients.

What evidence suggests that forimtamig might be an effective treatment for multiple myeloma?

Research has shown that forimtamig, the investigational treatment in this trial, yields promising results for relapsed or refractory multiple myeloma, a type of blood cancer. In previous studies, forimtamig proved more effective than other treatments targeting the GPRC5D and BCMA proteins, which play a role in multiple myeloma. Specifically, one study found that forimtamig helped about two-thirds of patients by noticeably reducing their cancer symptoms. These improvements were significant and lasted an average of 12.2 months, indicating a lasting effect. This evidence supports forimtamig's potential effectiveness in managing this challenging condition. ^{1 2 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. ashpublications.org ashpublications.org/blood/article/145/2/202/525824/Forimtamig-a-novel-GPRC5D-targeting-T-cell

Forimtamig, a novel GPRC5D-targeting T-cell bispecific ... Key PointsForimtamig exhibits superior potency compared with other GPRC5D- and BCMA-targeting TCBs.Forimtamig combination with TCBs and CELMoDs prevents tu.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11738037/

Forimtamig, a novel GPRC5D-targeting T-cell bispecific ... Forimtamig exhibits superior potency compared with other GPRC5D- and BCMA-targeting TCBs. Forimtamig combination with TCBs and CELMoDs prevents tumor ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04557150

NCT04557150 | A Study Evaluating the Safety and ... The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2). Official Title. An Open-Label, ...

4. targetedonc.com targetedonc.com/view/forimtamig-shows-deep-durable-responses-in-relapsed-refractory-multiple-myeloma

Forimtamig Shows Deep, Durable Responses in Relapsed/ ... At a median duration of response of 12.2 months, the objective response rates with forimtamig across all dose levels was 66.7% with a very good ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12361006/

T cell redirecting therapy for relapsed multiple myeloma - PMC Despite encouraging outcomes in registrational trials, long-term follow-up reveals that most patients eventually relapse. mPFS across pivotal ...

6. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/cancer/multiple-myeloma/a-study-evaluating-safety--tolerability--and-clinical-a-92792.pdf

A clinical trial to look at how safe forimtamig-based treatment ... The purpose of this study is to evaluate the safety, tolerability, and preliminary anti- tumor activity of forimtamig when administered alone or in ...

7. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/cancer/multiple-myeloma/a-study-evaluating-the-safety-and-pharmacokinetics-of-e-50454.html

Clinical Trial – A Study Evaluating the Safety and Pharma... A clinical trial to look at how safe forimtamig is at different doses, how the body processes it, and how well it works against multiple myeloma

8. sciencedirect.com sciencedirect.com/science/article/pii/S0006497124108300

Forimtamig, a novel GPRC5D-targeting T-cell bispecific ... Forimtamig is currently being evaluated in phase 1 clinical trials in patients with relapsed and refractory MM for monotherapy and in combination treatments.