What side effects are associated with this type of intervention?

Common treatments for advanced solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often result in a range of side effects. Chemotherapy agents like carboplatin and paclitaxel typically cause fatigue, nausea, neutropenia, and neuropathy. Targeted therapies, such as PI3K inhibitors like buparlisib, frequently lead to hyperglycemia, decreased appetite, and diarrhea. Immunotherapies, including PD-1 inhibitors like nivolumab, can result in immune-related adverse events such as rash, diarrhea, and fatigue. These side effects are important considerations when evaluating treatment options for advanced solid tumors.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced solid tumors, particularly focusing on immunotherapy and targeted therapies. Notable approvals include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which are immune checkpoint inhibitors targeting PD-1, used in various cancers such as melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, combination therapies like atezolizumab (Tecentriq) with bevacizumab (Avastin) have been approved for renal cell carcinoma. These treatments, similar to NB004, aim to enhance the body's immune response to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to NB004 for treating advanced solid tumors in 2024 include: 1) Pembrolizumab (Keytruda) - an immune checkpoint inhibitor showing efficacy in various solid tumors. 2) Nivolumab (Opdivo) - another immune checkpoint inhibitor with positive outcomes in multiple cancer types. 3) Atezolizumab (Tecentriq) - an anti-PD-L1 antibody used in combination therapies. 4) Cabozantinib - a tyrosine kinase inhibitor effective in combination with immunotherapies. 5) Futibatinib - an FGFR inhibitor for tumors with specific genetic alterations. These therapies have demonstrated promising results in clinical trials and are considered potential alternatives for advanced solid tumor treatment.

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Unknown

NB004 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Ningbo Newbay Technology Development Co., Ltd

Eligibility Criteria Checklist

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

Must have

Histologically and/or cytologically confirmed diagnosis of advanced solid tumors without standard treatment options (part 1)

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

Must not have

Female subjects who are pregnant, breastfeeding, or planning pregnancy within 3 months after the last dose

Toxicities from previous anti-cancer therapy that have not recovered

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months since the first subject enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial tests NB004, a new cancer drug, in patients with advanced, metastatic solid tumors who have no other treatment options. It aims to find the highest safe dose and see if the drug can help shrink tumors.

Who is the study for?

This trial is for adults (18+) with advanced solid tumors lacking standard treatment options. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory, measurable disease, and an expected lifespan of at least 12 weeks. They should not have had cancer therapy within the last 2-3 weeks and must not be pregnant or planning pregnancy.

What is being tested?

The study tests NB004 tablets as a single agent or combined with other therapies in patients with advanced solid tumors. It's an early-phase trial (Phase 1) focusing on safety, how well the body tolerates it, and how the drug behaves inside the body (pharmacokinetics).

What are the potential side effects?

While specific side effects of NB004 are not listed here, typical Phase 1 trials may observe fatigue, nausea, diarrhea, skin reactions among others depending on the drug's action mechanism. Close monitoring will identify any potential adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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My advanced cancer has no standard treatment options.

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I am fully active or can carry out light work.

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My cancer has a KRAS G12C mutation.

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My cancer can be measured or seen on tests.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I still have side effects from past cancer treatments.

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I do not have active infections like hepatitis B, C, or HIV.

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

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I have been treated with a PIM kinase inhibitor before.

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I haven't had cancer treatment in the last 2 weeks or within 5 half-lives of the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months since the first subject enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months since the first subject enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months since the first subject enrolled for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Benefit Rate (CBR) ----Part 3

Duration of Response (DOR) ----Part 3

Incidence of adverse events----Part 1/2

+5 more

Secondary study objectives

Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) ----Part 1

Clinical Benefit Rate (CBR) ----Part 2

Duration of Response(DOR)----Part 2

+7 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064

14%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Normal Hepatic Function

Moderate Hepatic Impairment

Severe Hepatic Impairment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NB004Experimental Treatment1 Intervention

Part1: Dose escalation phase of study drug NB004 monotherapy: Part 2: Dose Escalation Phase for the NB004 in combination with Sotorasib: Part 3: COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib:

0 / 10Eligibility 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

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. These mechanisms are crucial for patients with solid tumors as they offer different strategies to control tumor growth, manage symptoms, and potentially improve survival rates, especially in advanced stages where traditional treatments may be less effective.