240 Participants Needed

CAB-AXL-ADC + PD-1 Inhibitor for Lung Cancer

Recruiting at 60 trial locations
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Overseen ByBioAtla Medical Affairs
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: BioAtla, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for PD-1 inhibitors in lung cancer treatment?

PD-1 inhibitors, used in lung cancer treatment, can cause immune-related side effects like pneumonitis (lung inflammation), colitis (colon inflammation), and hepatitis (liver inflammation). These side effects are generally manageable, but in some cases, they can be severe and require stopping the treatment.12345

How is the drug CAB-AXL-ADC + PD-1 Inhibitor unique for lung cancer treatment?

The drug CAB-AXL-ADC + PD-1 Inhibitor is unique because it combines a novel antibody-drug conjugate (CAB-AXL-ADC) with a PD-1 inhibitor, potentially enhancing the immune system's ability to target and destroy cancer cells, which differs from standard treatments that typically involve chemotherapy or single-agent immune checkpoint inhibitors.678910

What data supports the effectiveness of the drug CAB-AXL-ADC + PD-1 Inhibitor for lung cancer?

Research shows that PD-1 inhibitors, which are part of this treatment, have been effective in treating advanced non-small cell lung cancer, especially when combined with other agents like chemotherapy or anti-angiogenic drugs. These combinations have improved survival rates and are approved for use in various settings, indicating potential effectiveness for the combination with CAB-AXL-ADC.6781112

Are You a Good Fit for This Trial?

Adults over 18 with non-small cell lung cancer (NSCLC) who have measurable disease, are in good physical condition (ECOG status of 0 or 1), and expected to live at least three months. They must have proper blood, kidney, and liver function. Those with severe heart issues, prior specific cancer treatments, recent major surgery, uncontrolled brain metastasis, certain allergies or infections like HIV/hepatitis are excluded.

Inclusion Criteria

My kidneys are working well.
I am fully active or restricted in physically strenuous activity but can do light work.
Life expectancy of at least three months.
See 3 more

Exclusion Criteria

I do not have uncontrolled brain metastases.
I have never had a severe allergic reaction to antibody treatments.
I am not pregnant or breastfeeding.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAB-AXL-ADC (BA3011) alone or in combination with a PD-1 inhibitor

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CAB-AXL-ADC
  • PD-1 inhibitor
Trial Overview The trial is testing the safety and effectiveness of a new drug called CAB-AXL-ADC for NSCLC patients. It's being compared against PD-1 inhibitors which are a type of immunotherapy that helps the immune system fight cancer cells.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: CAB-AXL-ADC (BA3011)+PD-1 inhibitorExperimental Treatment2 Interventions
Group II: CAB-AXL-ADC (BA3011)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioAtla, Inc.

Lead Sponsor

Trials
7
Recruited
1,500+

Published Research Related to This Trial

Single-agent immune checkpoint inhibitors (ICIs) significantly improve overall survival in patients with advanced non-small cell lung cancer (NSCLC) and PD-L1 expression ≥50% compared to platinum-based chemotherapy, with a hazard ratio of 0.68 based on data from 2111 participants across six trials.
Double-agent ICIs also likely enhance overall survival in the same patient group, showing a hazard ratio of 0.72 from two trials involving 612 participants, although their effects on progression-free survival and quality of life remain unclear.
Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer.Ferrara, R., Imbimbo, M., Malouf, R., et al.[2022]
In a review of 23 randomized controlled trials involving 15,797 patients, PD-1 inhibitors significantly improved overall survival (OS) by an average of 4.80 months compared to standard care, while PD-L1 inhibitors improved OS by 2.59 months.
PD-1 inhibitors were found to provide greater OS benefits than PD-L1 inhibitors, suggesting that PD-1 inhibitors may be the preferred choice for treating advanced non-small-cell lung cancer (NSCLC), especially in patients with varying PD-L1 expression levels.
The relative and absolute benefit of programmed death receptor-1 vs programmed death ligand 1 therapy in advanced non-small-cell lung cancer: A systematic review and meta-analysis.Yi, K., Zhu, Q., Kuang, YK., et al.[2021]
Single-agent immune checkpoint inhibitors (ICIs) significantly improve overall survival in patients with advanced non-small cell lung cancer (NSCLC) and PD-L1 expression ≥50% compared to platinum-based chemotherapy, with a hazard ratio of 0.68 based on data from 2111 participants across six trials.
Double-agent ICI treatment also likely enhances overall survival in the same patient group, with a hazard ratio of 0.72 from 612 participants in two trials, although data on progression-free survival and quality of life are limited.
Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer.Ferrara, R., Imbimbo, M., Malouf, R., et al.[2022]

Citations

Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer. [2022]
The relative and absolute benefit of programmed death receptor-1 vs programmed death ligand 1 therapy in advanced non-small-cell lung cancer: A systematic review and meta-analysis. [2021]
PD-1/PD-L1 inhibitors plus anti-angiogenic agents with or without chemotherapy versus PD-1/PD-L1 inhibitors plus chemotherapy as second or later-line treatment for patients with advanced non-small cell lung cancer: A real-world retrospective cohort study. [2023]
[Immune checkpoint inhibitors in lung cancer]. [2020]
Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer. [2022]
Adverse events of different PD-1 inhibitors in lung cancer patients: a real-world study. [2022]
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]
Safety of Programmed Death-1 Pathway Inhibitors Among Patients With Non-Small-Cell Lung Cancer and Preexisting Autoimmune Disorders. [2022]
Acute coronary syndrome and recurrent colitis as immune-related adverse events in a lung cancer patient. [2020]
Association of immune-related pneumonitis with the efficacy of PD-1/PD-L1 inhibitors in non-small cell lung cancer. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Current Perspectives in Immunotherapy for Non-Small Cell Lung Cancer. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Emerging immunotherapies in the treatment of non-small cell lung cancer (NSCLC): the role of immune checkpoint inhibitors. [2020]
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