Spartalizumab Safety for Cancer

Recruiting at 53 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to ensure that spartalizumab remains safe and tolerable for patients who are already using it. The medication helps the immune system fight cancer, and the study ensures patients can keep accessing it safely.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems focused on participants already receiving spartalizumab, so it's best to ask the study team for details.

What data supports the effectiveness of the drug Spartalizumab for cancer?

Research shows that Spartalizumab, when used alone or with Sabatolimab, has shown preliminary effectiveness in treating advanced solid tumors, with some patients experiencing partial tumor shrinkage. Additionally, Sabatolimab has shown promise in enhancing the immune response against cancer cells in other conditions, suggesting potential benefits when combined with Spartalizumab. ^{1 2 3 4 5}

Is Spartalizumab safe for humans?

Research shows that Spartalizumab, tested in patients with advanced cancers, is generally safe at doses up to 10 mg/kg every 2 weeks. Common side effects include skin rash, tiredness, and increased levels of a liver enzyme, but no severe dose-limiting toxicities were reported. ^{1 2 3 4 6}

What makes the drug Spartalizumab unique for cancer treatment?

Spartalizumab is unique because it is a monoclonal antibody that targets PD-1, a protein on immune cells, to help the immune system attack cancer cells. When combined with Sabatolimab, which targets TIM-3, it offers a novel approach by blocking two different pathways that tumors use to evade the immune system, potentially enhancing the antitumor response. ^{1 2 3 4 6}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for patients already participating in a Novartis-sponsored study, receiving spartalizumab alone or with other treatments for solid tumors. They must be benefiting from the treatment as judged by their doctor and meet all other ongoing study requirements.

Inclusion Criteria

I am currently in a Novartis study and receiving spartalizumab.

I am benefiting from the current treatment, as confirmed by my doctor.

I am currently in a Novartis study and receiving spartalizumab alone or with other treatments.

Exclusion Criteria

I was taken off spartalizumab for reasons other than joining another study.

Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue to receive spartalizumab as a single agent or in combination with other study treatments

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Spartalizumab

Trial Overview The trial continues to evaluate the safety and tolerability of spartalizumab, an investigational drug, given either alone or alongside other treatments to those who have been taking it and are seeing positive results.

Participant Groups

Group I: PDR001 Experimental Treatment 1 Intervention

All subjects in all combination will be entered in one arm

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

In a phase I/II study involving 219 patients with advanced solid tumors, the combination of sabatolimab and spartalizumab was well tolerated, with fatigue being the most common treatment-related side effect.

While no responses were observed with sabatolimab alone, the combination treatment showed preliminary antitumor activity, with 5 patients achieving partial responses in various cancers, suggesting potential efficacy in specific populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/Ib Clinical Trial of Sabatolimab, an Anti-TIM-3 Antibody, Alone and in Combination with Spartalizumab, an Anti-PD-1 Antibody, in Advanced Solid Tumors. Curigliano, G., Gelderblom, H., Mach, N., et al.[2023]

In a phase 1/2 study involving 58 patients with advanced solid tumors, spartalizumab was found to be well tolerated with no dose-limiting toxicities, indicating a favorable safety profile for this PD-1 blocking antibody.

Although spartalizumab showed limited clinical activity with a response rate of only 3.4% in this heavily pretreated population, there was evidence of immune activation, as indicated by increased CD8+ lymphocyte infiltration in tumor biopsies from patients who experienced clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors. Naing, A., Gainor, JF., Gelderblom, H., et al.[2023]

In a phase I study involving 18 patients with advanced cancers, spartalizumab was found to be safe at doses up to 10 mg/kg every two weeks, with no dose-limiting toxicities reported.

The study showed preliminary antitumor activity, with partial responses observed in 11% of patients, indicating potential effectiveness in treating certain types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of the antiprogrammed cell death-1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. Minami, H., Doi, T., Toyoda, M., et al.[2021]

Sabatolimab, a humanized anti-TIM-3 monoclonal antibody, is being developed for treating myeloproliferative disorders like acute myeloid leukemia, showcasing its potential as a novel immunotherapy.

This therapy works through multiple mechanisms, including blocking TIM-3 and its ligands, modulating leukemic cell self-renewal, and promoting antibody-dependent phagocytosis of TIM-3-expressing leukemic cells, which may enhance the overall antitumor immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIM-3: a tumor-associated antigen beyond checkpoint inhibition? Barth, S., Naran, K.[2023]

In a phase 2 trial involving 127 patients with higher-risk myelodysplastic syndromes, the addition of sabatolimab to hypomethylating agents did not significantly improve complete response rates or progression-free survival compared to placebo.

Despite the lack of significant efficacy, sabatolimab was generally well-tolerated, with manageable safety profiles, although there was one treatment-related death due to pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sabatolimab plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes (STIMULUS-MDS1): a randomised, double-blind, placebo-controlled, phase 2 trial. Zeidan, AM., Ando, K., Rauzy, O., et al.[2023]

Sabatolimab, a humanized monoclonal antibody targeting TIM-3, enhances T-cell killing and boosts inflammatory cytokine production by dendritic cells, indicating its potential to improve immune responses against cancer.

The antibody also facilitates the phagocytosis of TIM-3-expressing target cells and blocks TIM-3 interactions with its ligands, suggesting it has both direct anti-leukemic effects and immune-modulating properties, making it a promising candidate for treating myeloid cell neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of sabatolimab, a novel immunotherapy with immuno-myeloid activity directed against TIM-3 receptor. Schwartz, S., Patel, N., Longmire, T., et al.[2023]

References

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

Phase I/Ib Clinical Trial of Sabatolimab, an Anti-TIM-3 Antibody, Alone and in Combination with Spartalizumab, an Anti-PD-1 Antibody, in Advanced Solid Tumors. [2023]

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

A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Phase I study of the antiprogrammed cell death-1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. [2021]

4. England pubmed.ncbi.nlm.nih.gov

TIM-3: a tumor-associated antigen beyond checkpoint inhibition? [2023]

5. England pubmed.ncbi.nlm.nih.gov

Sabatolimab plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes (STIMULUS-MDS1): a randomised, double-blind, placebo-controlled, phase 2 trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Characterization of sabatolimab, a novel immunotherapy with immuno-myeloid activity directed against TIM-3 receptor. [2023]