What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, particularly those involving targeted therapy and immune checkpoint inhibitors, include drugs like Olaparib and Pembrolizumab. Olaparib, a PARP inhibitor, is associated with side effects such as anemia, nausea, fatigue, and vomiting. Pembrolizumab, an immune checkpoint inhibitor, can cause immune-related adverse events including fatigue, rash, diarrhea, and endocrinopathies. These treatments aim to improve survival and quality of life but come with a risk of significant side effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immune checkpoint inhibitors for the treatment of ovarian cancer. Notably, bevacizumab, a monoclonal antibody targeting VEGF, has been approved for use in combination with chemotherapy for advanced ovarian cancer. Additionally, PARP inhibitors such as olaparib, niraparib, and rucaparib have been approved for patients with BRCA mutations or homologous recombination deficiencies. Immune checkpoint inhibitors like pembrolizumab, which targets PD-1, have also been approved for use in certain cases of ovarian cancer, particularly those with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These treatments align with the mechanisms of action being studied in the trial involving LVGN3616 and LVGN6051.

What other types of research exist?

Promising novel alternatives for ovarian cancer treatment in 2024 include PARP inhibitors (e.g., olaparib, niraparib) for patients with BRCA mutations or homologous recombination deficiency, and immune checkpoint inhibitors like pembrolizumab, especially in combination with other agents. Additionally, antibody-drug conjugates (e.g., mirvetuximab soravtansine) and novel agents targeting specific molecular pathways (e.g., bevacizumab targeting VEGF) are also showing potential.

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Monoclonal Antibodies

LVGN3616 + LVGN6051 Combinations for Advanced Cancers

Phase 1

Recruiting

Led By Siqing Fu

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Male or female aged ≥18 years.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Must not have

Symptomatic primary tumors or metastasis in the brain and/or central nervous system

Unresolved clinically significant Grade 1 or higher toxicity from prior therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing new cancer drugs combined with existing chemotherapy treatments. It targets patients with specific types of tumors that may not respond well to standard treatments. The new drugs aim to stop cancer cells from growing or make them more vulnerable to chemotherapy.

Who is the study for?

Adults (≥18 years) with certain metastatic solid tumors, measurable disease, good performance status (ECOG 0-1), and adequate organ function can join. They must not have unresolved significant side effects from past treatments or be on conflicting trials or medications. Pregnant women, those with active severe infections like HIV/Hepatitis B/C, recent live vaccines, autoimmune diseases needing treatment in the last 2 years, or a history of severe reactions to monoclonal antibody therapy are excluded.

What is being tested?

The trial is testing combinations of new drugs LVGN3616 and LVGN6051 with/without LVGN7409 alongside Nab-Paclitaxel or Bevacizumab and Cyclophosphamide for their effectiveness against selected metastatic cancers. It's an early-phase study to see how well these drug combos work.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues such as nausea, fatigue, hair loss from Nab-Paclitaxel; high blood pressure and bleeding risks from Bevacizumab; immune system complications due to the investigational drugs which could lead to inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer has spread, and its genetic makeup was tested in a certified lab.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I am not pregnant and am using effective birth control.

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I am 18 years old or older.

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I can carry out all my usual activities without help.

Exclusion Criteria

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

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I have symptoms from cancer in my brain or spinal cord.

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I still have noticeable side effects from previous treatments.

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I do not have any unmanaged ongoing illnesses.

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I am on HAART for HIV or have active hepatitis B or C.

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I am currently on immunosuppressive therapy or taking more than 10 mg/day of prednisone or its equivalent.

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I do not have any other active cancers needing treatment besides hormone therapy.

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My cancer has spread to the lining of my brain or spinal cord, or to my lymph system.

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I have had severe side effects from previous immunotherapy.

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I have had lung inflammation that needed steroids or have it now.

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I have another type of cancer that is affecting my health right now.

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I have had a severe allergic reaction to monoclonal antibody treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Group I: Regimen D: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + CyclophosphamideExperimental Treatment4 Interventions

given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).

Group II: Regimen C: LVGN3616 + LVGN6051 + LVGN7409 + Nab-PaclitaxelExperimental Treatment4 Interventions

given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).

Group III: Regimen B: LVGN3616 + LVGN6051 + Bevacizumab + CyclophosphamideExperimental Treatment4 Interventions

given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).

Group IV: Regimen A: LVGN3616 + LVGN6051 + Nab-PaclitaxelExperimental Treatment4 Interventions

given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).

0 / 18Eligibility 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

Targeted therapies, such as PARP inhibitors, exploit DNA repair weaknesses in cancer cells, particularly those with BRCA mutations, leading to cell death. Immune checkpoint inhibitors, like pembrolizumab, block proteins such as PD-1 or PD-L1 that prevent the immune system from attacking cancer cells, allowing the immune system to recognize and destroy cancer cells more effectively. These mechanisms are crucial for ovarian cancer patients as they offer more personalized and potentially more effective treatment options, especially for those with specific genetic profiles or those who have not responded well to traditional chemotherapy.

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Who is running the clinical trial?

Lyvgen Biopharma Holdings LimitedIndustry Sponsor

6 Previous Clinical Trials

582 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,349 Total Patients Enrolled

48 Trials studying Ovarian Cancer

16,789 Patients Enrolled for Ovarian Cancer

Siqing FuPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

190 Total Patients Enrolled

~159 spots leftby Feb 2027

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