Obrixtamig + ZL-1310 for Small Cell Lung Cancer

Not yet recruiting at 28 trial locations
BI
Overseen ByBoehringer Ingelheim
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments to combat advanced small cell lung cancer and other neuroendocrine cancers. The study occurs in two parts. Part 1 aims to determine the right dose of two potential drugs, obrixtamig and ZL-1310. Part 2 introduces another medicine to assess the combination's effectiveness and patient tolerance. Individuals with advanced small cell lung cancer who haven't responded to other treatments might be suitable candidates. As a Phase 1/Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering patients a chance to benefit from these new therapies.

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, it mentions restrictions regarding prohibited medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of obrixtamig and ZL-1310 is generally safe for humans. A previous study found no severe side effects, such as serious immune reactions or brain-related issues, in patients taking ZL-1310. Most side effects were mild to moderate, including nausea or tiredness.

When combined with another drug, like atezolizumab, the side effects remain manageable. Although some patients experienced more serious side effects, these were less common. These findings help doctors assess the safety of these treatments for people with small cell lung cancer.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Obrixtamig + ZL-1310 because this combination offers a novel approach to treating small cell lung cancer. Unlike traditional chemotherapy, which targets all rapidly dividing cells, this treatment specifically targets cancer cells, potentially reducing side effects and increasing effectiveness. The inclusion of atezolizumab in Part 2 aims to enhance the immune system's ability to fight cancer, a promising strategy not commonly used in current standard treatments. This targeted approach and the potential to combine with immunotherapy could lead to improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

Research shows that combining obrixtamig and ZL-1310 may help treat small cell lung cancer. In earlier studies, ZL-1310 alone achieved a 74% success rate in shrinking tumors in patients with advanced small cell lung cancer. Obrixtamig, the other drug in the combination, demonstrated a 54% success rate in treating another type of cancer, suggesting potential effectiveness. In this trial, participants will receive either obrixtamig and ZL-1310 in different dosing regimens or the combination of obrixtamig, ZL-1310, and atezolizumab. When used with atezolizumab, a medicine that helps the immune system fight cancer, studies found the treatment generally safe and free of unexpected side effects. These results suggest that this combination could effectively control cancer growth.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced small cell lung cancer or other neuroendocrine cancers. Part 2 is only for those with advanced small cell lung cancer. Participants must be able to visit the study site regularly and tolerate intravenous treatments.

Inclusion Criteria

For both Part 1 and Part 2: Signed and dated written informed consent per ICH-GCP and local legislation prior to trial procedures
My tumor is mostly made up of neuroendocrine or small cell cancer cells (at least 50%).
I have tried all proven treatments, including platinum chemotherapy, unless it was unsafe for me.
See 6 more

Exclusion Criteria

Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers or laboratory abnormalities that may impact safety, compliance, or assessment validity
I have received an organ or tissue transplant.
Known hypersensitivity to trial drugs or excipients, prior severe life-threatening hypersensitivity to monoclonal antibodies, or significant risk of allergic/anaphylactic reactions to investigational drugs
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive obrixtamig and ZL-1310 to find a suitable dose

Up to 24 months
Regular visits with some overnight stays

Treatment Part 2

Participants receive obrixtamig, ZL-1310, and a checkpoint inhibitor to assess tolerance and efficacy

Up to 24 months
Regular visits with some overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Obrixtamig
  • ZL-1310

Trial Overview

Researchers are testing a combination of two new drugs, obrixtamig and ZL-1310, given by IV infusion. In the second part, these are combined with another drug called a checkpoint inhibitor (like atezolizumab) to see if this approach can help control cancer growth.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part 2: obrixtamig + ZL-1310 + atezolizumabExperimental Treatment3 Interventions
Group II: Part 1: obrixtamig + ZL-1310 (dosing regimen 2)Experimental Treatment2 Interventions
Group III: Part 1: obrixtamig + ZL-1310 (dosing regimen 1)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

Zai Lab

Collaborator

Citations

Boehringer Ingelheim and Zai Lab announce Collaboration on ...

Obrixtamig is being evaluated across multiple global studies and is advancing into a global Phase III trial (DAREON ® ‑Lung‑1, NCT07472517). The ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40706016/

Phase I Dose-Escalation Results for the Delta-Like Ligand ...

Results: As of February 21, 2024, 168 patients received obrixtamig, 72% received ≥2 lines of previous anticancer therapy, and 51% received ...

FDA Grants ZL-1310 Fast Track Designation for Extensive ...

ZL-1310 earns Fast Track Designation as a potential first-in-class DLL3-targeted ADC for extensive-stage small cell lung cancer.

A randomized, open-label, phase 3 study of ZL-1310 ...

ZL-1310 has demonstrated encouraging systemic efficacy in heavily pre-treated ES-SCLC and showed intracranial activities.

Watch as Jacob Sands, MD of Dana-Farber Cancer Institute ...

ZL- 1310 patients saw no cytokine release syndrome or ICANS, another kind of cancer therapy toxicity.

Boehringer Ingelheim and Zai Lab announce Collaboration ...

The Phase Ib/II study will assess the safety, tolerability, and initial clinical activity of combining obrixtamig, Boehringer Ingelheim's DLL3/ ...

NCT04429087 | A Study to Test Different Doses of ...

This study is open to adults with small cell lung cancer. Obrixtamig is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight ...

What Is On the Horizon for the Diagnosis and Treatment of ...

A subsequent report evaluating obrixtamig in patients with LCNEC (n = 14) found an ORR of 54% and a PFS of 3.6 months. Obrixtamig is currently being evaluated ...

zocilurtatug pelitecan (ZL-1310) / ZAI Lab, MediLink

Preliminary results from the phase 1b/2, open-label, multi-center study of ZL-1310, a DLL3-targeted ADC, in patients with neuroendocrine carcinomas and ...