Runimotamab for Solid Tumors

Recruiting at 42 trial locations

Overseen By Reference Study ID Number: GO40311 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: QT-prolonging medications

Disqualifiers: Pregnancy, Cardiopulmonary dysfunction, Liver disease, Hepatitis, HIV, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

123 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment, Runimotamab, given alone or with another drug, in patients with advanced cancers that have a lot of a specific protein. The drugs work by attaching to this protein on cancer cells to stop their growth. Hersintuzumab is a new treatment that targets a different part of the protein.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that prolong the QT interval (a heart rhythm measurement), you may need to stop those.

What data supports the effectiveness of the drug Runimotamab for solid tumors?

Research on immune checkpoint inhibitors, which are similar to Runimotamab, shows they can be effective in treating various solid tumors, even in patients with poor health status. These treatments work by helping the immune system attack cancer cells, and studies have shown they can improve survival rates in some patients. ^{1 2 3 4 5}

What makes the drug Runimotamab unique for treating solid tumors?

Runimotamab is likely an antibody-drug conjugate (ADC), which is a type of treatment that combines an antibody with a drug to specifically target and kill cancer cells, making it different from traditional chemotherapy that affects both healthy and cancerous cells. ^{6 7 8 9 10}

Research Team

Clinical Trials

Principal Investigator

Genentech, Inc.

Eligibility Criteria

This trial is for people with advanced or metastatic HER2-expressing cancers who have tried at least one standard therapy without success, or can't tolerate it. They should expect to live at least 12 weeks, be in good physical condition (ECOG 0-1), and have a heart pumping function (LVEF) of at least 50%. People with untreated brain metastases, significant heart/lung problems, certain infections like HIV/HCV, uncontrolled diabetes, or those pregnant cannot join.

Inclusion Criteria

My breast cancer is HER2 positive and has either returned or didn't respond to treatment.

My cancer is HER2-positive and has not responded well to standard treatments.

My stomach cancer is advanced, cannot be surgically removed, and has been treated with specific drugs including trastuzumab.

Exclusion Criteria

I have Hepatitis C.

I am not on medications that affect heart rhythm.

I have had a previous transplant of stem cells or an organ.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD)

8-12 weeks

Dose Expansion

Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Runimotamab

Trial Overview The study tests Runimotamab alone and combined with Trastuzumab on participants with HER2-positive cancers. It aims to understand the safety and how the body processes these drugs when given through an IV.

Participant Groups

Group I: Dose Expansion Experimental Treatment 3 Interventions

Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.

Group II: Dose Escalation Experimental Treatment 3 Interventions

Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

In a study of 502 patients with dMMR/MSI-H metastatic colorectal cancer, worse performance status (PS) was associated with significantly poorer progression-free survival (PFS) and overall survival (OS), indicating that PS is a crucial prognostic factor in treatment outcomes.

The combination therapy of anti-PD-1 and anti-cytotoxic T-lymphocyte antigen 4 showed significant survival benefits only in patients with cancer-related PS ≥ 1, while it did not outperform anti-PD(L)-1 monotherapy in patients with better PS, suggesting that treatment decisions should consider PS and other clinical variables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic impact of performance status on the outcomes of immune checkpoint inhibition strategies in patients with dMMR/MSI-H metastatic colorectal cancer. Mazzoli, G., Cohen, R., Lonardi, S., et al.[2022]

In a study of 155 patients with advanced solid tumors, those with a better performance status (ECOG PS 0-1) had a median overall survival (OS) of 9.1 months, compared to only 2.9 months for those with poorer performance status (ECOG PS 2-4), indicating that performance status significantly impacts treatment outcomes with immune checkpoint inhibitors (ICIs).

Despite having a poor performance status, 27.3% of patients in the study were still alive after one year, and the treatment was generally well-tolerated, with 84.6% of patients experiencing no severe toxicities, suggesting that ICIs can be a safe and effective option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitors in patients with solid tumors and poor performance status: A prospective data from the real-world settings. Kapoor, A., Noronha, V., Patil, VM., et al.[2023]

In a study of 65 patients with various cancers treated with PD1-targeting antibodies, specific immune-related gene expressions were identified that correlated with better responses to treatment and longer progression-free survival (PFS).

The findings suggest that measuring preexisting immune responses through mRNA expression patterns can reliably predict clinical outcomes in patients receiving PD1 therapy, regardless of cancer type or the specific antibody used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Related Gene Expression Profiling After PD-1 Blockade in Non-Small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, and Melanoma. Prat, A., Navarro, A., Paré, L., et al.[2022]

Immunotherapy, particularly immune checkpoint inhibitors, has significantly improved treatment outcomes for high-risk resectable and metastatic melanoma, showcasing its effectiveness across various cancer types.

The success of immunotherapy in melanoma has led to its approval and evaluation in other solid tumors, indicating a broader application of these therapies in both early and advanced stages of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current Landscape of Immune Checkpoint Inhibition for Solid Malignancies. Keung, EZ., Wargo, JA.[2020]

Targeted and immunological therapies have significantly improved survival rates in patients with solid tumors, demonstrating the effectiveness of treatments that focus on specific genetic and immunological changes in tumors.

Current clinical trials are exploring the optimal timing and sequencing of these therapies, which include various approved agents for cancers like prostate, breast, lung, and melanoma, indicating a shift towards more personalized cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy of solid tumors. New hopes and frustrations]. Grünwald, V., Rickmann, M.[2021]

Avelumab, a monoclonal antibody targeting PD-L1, demonstrated an acceptable safety profile in a phase 1a trial with 53 patients, with only one dose-limiting toxicity observed at the highest dose of 20 mg/kg, indicating that the maximum tolerated dose was not reached.

The pharmacokinetic analysis showed a dose-proportional exposure and a half-life of approximately 4 days at higher doses, leading to the selection of 10 mg/kg every 2 weeks for further development, as it achieved over 90% target occupancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Heery, CR., O'Sullivan-Coyne, G., Madan, RA., et al.[2022]

References

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

The prognostic value of prognostic nutritional index in advanced cancer receiving PD-1/L1 inhibitors: A meta-analysis. [2022]

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

Prognostic impact of performance status on the outcomes of immune checkpoint inhibition strategies in patients with dMMR/MSI-H metastatic colorectal cancer. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Turning tumors from cold to inflamed to improve immunotherapy response. [2021]

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

Immune checkpoint inhibitors in patients with solid tumors and poor performance status: A prospective data from the real-world settings. [2023]

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

Immune-Related Gene Expression Profiling After PD-1 Blockade in Non-Small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, and Melanoma. [2022]

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

The Current Landscape of Immune Checkpoint Inhibition for Solid Malignancies. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy of solid tumors. New hopes and frustrations]. [2021]

9. France pubmed.ncbi.nlm.nih.gov

Antibody-Drug Conjugates for the Treatment of Solid Tumors: Clinical Experience and Latest Developments. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. [2022]