55 Participants Needed

CTX-8371 for Advanced Cancer

Recruiting at 6 trial locations
NW
Overseen ByNatalie Warholic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had systemic therapy with immunosuppressive agents within 7 days before starting the trial treatment.

What data supports the effectiveness of the drug CTX-8371 for advanced cancer?

The research shows that PD-1 and PD-L1 inhibitors, which are similar to components of CTX-8371, have shown promising results in treating advanced non-small-cell lung cancer (NSCLC). Additionally, PD-L1 expression is a marker of treatment efficacy, suggesting that targeting PD-1/PD-L1 pathways can be effective in cancer treatment.12345

What safety information is available for CTX-8371 (PD-1 x PD-L1) in humans?

Drugs targeting PD-1 and PD-L1, like CTX-8371, can cause side effects such as skin issues (dermatitis) and other immune-related reactions. These side effects have been observed in various cancer treatments using similar drugs.678910

What makes the drug CTX-8371 unique for treating advanced cancer?

CTX-8371 is unique because it targets both PD-1 and PD-L1, which are proteins involved in suppressing the immune system's ability to attack cancer cells. This dual targeting approach may enhance the immune response against cancer compared to treatments that target only one of these proteins.25111213

What is the purpose of this trial?

This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.

Eligibility Criteria

This trial is for adults with advanced cancers like breast cancer, lung cancer, or melanoma that have stopped responding to standard treatments. Participants must have tried a PD-1/PD-L1 inhibitor and, if they have a specific mutation (BRAF V600), also BRAF/MEK inhibitors.

Inclusion Criteria

My Hodgkin Lymphoma did not fully respond to anti-PD-1 treatment.
I am fully active or can carry out light work.
My blood tests show enough neutrophils, platelets, and hemoglobin.
See 23 more

Exclusion Criteria

I haven't taken strong immune system drugs in the last week, except for creams, nasal sprays, eye drops, or inhalers.
I have had an organ transplant.
I stopped PD-1 or PD-L1 therapy due to a severe side effect.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of CTX-8371 to evaluate safety and tolerability

6 months
IV infusion every 2 weeks

Dose Expansion

Participants receive CTX-8371 at doses determined from the Dose Escalation phase

up to 2 years
IV infusion every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

  • CTX-8371
Trial Overview The study tests CTX-8371 as a solo treatment in two parts: first finding the right dose and then seeing how well it works at that dose. It's for patients whose cancers haven't responded to other therapies.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Dose Expansion Cohort 2Experimental Treatment1 Intervention
Dose of CTX-8371 depending on Cohort 1 data
Group II: Dose Escalation Cohort 1Experimental Treatment1 Intervention
Escalating doses of CTX-8371

Find a Clinic Near You

Who Is Running the Clinical Trial?

Compass Therapeutics

Lead Sponsor

Trials
5
Recruited
430+

Findings from Research

In a phase II study of 39 patients with advanced non-small cell lung cancer (NS-NSCLC) and high PD-L1 expression, the combination of atezolizumab and bevacizumab resulted in a promising objective response rate of 64.1%, indicating significant efficacy in this patient population.
The treatment showed a 12-month progression-free survival rate of 54.9% and an overall survival rate of 70.6%, with manageable safety profiles, as no patients experienced severe toxicity (grade 4/5), although some did experience serious adverse events.
Phase II study of atezolizumab with bevacizumab for non-squamous non-small cell lung cancer with high PD-L1 expression (@Be Study).Seto, T., Nosaki, K., Shimokawa, M., 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]
Insulin and EGF play a crucial role in increasing PD-L1 levels on colon cancer stem cells (CSCs), with insulin activating the PI3K/Akt/mTOR pathway to boost PD-L1 expression, while EGF enhances its transport to the cell surface.
Targeting the insulin and EGF pathways may improve cancer immunotherapy strategies by reducing PD-L1 levels on CSCs, potentially making them more susceptible to immune attacks when combined with PD-1/PD-L1 antibody treatments.
Insluin and epithelial growth factor (EGF) promote programmed death ligand 1(PD-L1) production and transport in colon cancer stem cells.Chen, M., Sharma, A., Lin, Y., et al.[2020]

References

Phase II study of atezolizumab with bevacizumab for non-squamous non-small cell lung cancer with high PD-L1 expression (@Be Study). [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]
Insluin and epithelial growth factor (EGF) promote programmed death ligand 1(PD-L1) production and transport in colon cancer stem cells. [2020]
[Expression and prognostic value of programmed cell death ligand 1 in patients with locally advanced and non-EGFR-mutated non-small cell lung cancer receiving concurrent chemoradiotherapy]. [2022]
Prevalence and Heterogeneity of PD-L1 Expression by 22C3 Assay in Routine Population-Based and Reflexive Clinical Testing in Lung Cancer. [2021]
Anti-PD-1 and anti-PD-L1 drugs treatment-related adverse events for patients with cancer: Protocol for an overview of systematic reviews with meta-analyses. [2023]
Characterization of dermatitis after PD-1/PD-L1 inhibitor therapy and association with multiple oncologic outcomes: A retrospective case-control study. [2020]
Treatment-Related Adverse Events of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-analysis. [2022]
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Immune-related adverse events and outcomes among pan-cancer patients receiving immune checkpoint inhibitors: A monocentric real-world observational study. [2023]
PD-L1 Over-Expression Varies in Different Subtypes of Lung Cancer: Will This Affect Future Therapies? [2022]
Serum-derived exosomal PD-L1 expression to predict anti-PD-1 response and in patients with non-small cell lung cancer. [2021]
PD-L1 expression in lung adenocarcinoma harboring EGFR mutations or ALK rearrangements. [2022]
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