What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapies, and immunotherapies. Chemotherapy agents like paclitaxel and carboplatin can cause neutropenia, fatigue, and hypertension. Targeted therapies, such as tyrosine kinase inhibitors, may lead to adverse events like cutaneous squamous-cell carcinoma and tumor-related bleeding, especially in patients with squamous cell histology. Immunotherapies, including pembrolizumab and atezolizumab, are associated with side effects such as fatigue, nausea, and increased liver function tests. Serious adverse events, although less common, can include intracranial hemorrhage and pulmonary hemorrhage.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and targeted therapy drugs. Pembrolizumab, an anti-PD-1 antibody, has been approved for use in combination with chemotherapy for advanced NSCLC, as demonstrated in the KEYNOTE-407 and KEYNOTE-189 trials. Atezolizumab, another immunotherapy drug, has been approved in combination with chemotherapy and bevacizumab for advanced nonsquamous NSCLC, as shown in the IMpower150 trial. Additionally, targeted therapies like sotorasib and adagrasib have been approved for KRAS G12C-mutated NSCLC. These treatments are similar to the investigational drug HB0036, which is being studied for its safety and efficacy in advanced solid tumors, including NSCLC.

What other types of research exist?

Promising novel alternatives to HB0036 for NSCLC patients include Furmonertinib, which has shown efficacy and an acceptable safety profile in a phase 3 study for EGFR mutation-positive NSCLC. Additionally, LY2603618 in combination with pemetrexed has shown comparable results to historical data for advanced NSCLC. These options represent potential treatment avenues for NSCLC patients in 2024.

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HB0036 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.

Eligibility Criteria Checklist

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

Must have

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

Phase II: Histologically or cytologically documented locally advanced, recurrent or metastatic cancer

Must not have

Women who are pregnant or lactating, or women of childbearing potential who do not wish to use effective contraception method during the trial

Have received antibiotics lasting over 1 week within 28 days prior to first dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called HB0036 in patients with advanced solid tumors, including NSCLC. The goal is to determine if the drug is safe and effective in treating these cancers.

Who is the study for?

Adults with advanced solid tumors, measurable cancer lesions, good performance status (able to carry out daily activities), and proper organ function can join this trial. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include recent severe allergic reactions to similar drugs, certain heart conditions within the past 6 months, active infections like HIV or hepatitis B/C, other recent treatments or trials, substance abuse issues.

What is being tested?

The study is testing HB0036's safety and effectiveness in treating advanced solid tumors including non-small cell lung cancer. It's an early-phase trial assessing how the body processes the drug (pharmacokinetics), its impact on the body (pharmacodynamics), and its potential benefits.

What are the potential side effects?

While specific side effects of HB0036 are not listed here due to it being an early-stage trial, common side effects for cancer treatments may include fatigue, nausea, inflammation at injection sites, immune system reactions that could affect organs' functions.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My cancer is advanced, recurrent, or has spread to other parts.

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My cancer is advanced and has not responded to standard treatments.

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I have confirmed I am not pregnant with a test 3 days before starting the study.

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, and if able to bear children, I agree to use contraception during the trial.

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I have taken antibiotics for more than a week in the last month.

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I have had lung conditions not caused by infections or from radiotherapy.

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I have active cancer spread to my brain or its coverings.

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I am currently being treated for TB or was treated for TB within the last year.

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I haven't had major surgery or cancer treatment in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

MTD

Safety and tolerability

Secondary study objectives

AUC

Cmax

Tmax

Other study objectives

ORR assessment in dose-escalation phase

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: HB0036Experimental Treatment1 Intervention

HB0036 IV every 3 weeks (q3w)

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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cancer cells, but it also affects normal cells, leading to side effects. Immunotherapy, such as nivolumab and pembrolizumab, enhances the body's immune system to recognize and attack cancer cells by targeting immune checkpoints like PD-1/PD-L1. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), specifically inhibit cancer cell growth and survival pathways, often with fewer side effects compared to chemotherapy. These treatments are crucial for NSCLC patients as they offer different mechanisms to control cancer progression, improve survival rates, and maintain quality of life.