Telisotuzumab Adizutecan + Budigalimab for Non-Small Cell Lung Cancer

Recruiting at 60 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AbbVie

Disqualifiers: Uncontrolled CNS metastases, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and safety of a new drug combination for treating advanced or metastatic non-small cell lung cancer (NSCLC). It first tests telisotuzumab adizutecan with budigalimab, an experimental treatment, followed by telisotuzumab adizutecan with pembrolizumab, a common treatment. The trial seeks participants with NSCLC who have not undergone extensive prior treatment and do not have certain known genetic changes. Participants must visit the clinic regularly for check-ups and tests. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

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

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

Research shows that telisotuzumab adizutecan, combined with treatments like budigalimab, is under study for its safety in treating non-small cell lung cancer (NSCLC). Earlier studies with patients who have advanced cancer, including those with specific tumor mutations, indicated that this combination might be effective. However, side effects can occur with any treatment.

Initial findings suggest that patients generally tolerated the combination of telisotuzumab adizutecan and budigalimab well, but further research is needed to fully understand its safety. These studies are in the early stages to determine the optimal and safe dose.

When telisotuzumab adizutecan is combined with pembrolizumab, another study showed it might be effective for similar patients. Safety information is still being gathered, but early results suggest many patients tolerate it well.

Overall, these treatments remain under investigation. The studies aim to identify the safest and most effective doses, making ongoing trials crucial for understanding any risks. Participants in these trials are closely monitored for side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about telisotuzumab adizutecan because it targets c-Met, a protein often overexpressed in non-small cell lung cancer (NSCLC), potentially offering a more direct attack on cancer cells than traditional treatments. Unlike most standard therapies that focus on immune checkpoint blockade or chemotherapy, telisotuzumab adizutecan combines an antibody targeting c-Met with a cytotoxic agent, which could enhance its ability to kill cancer cells. Additionally, budigalimab is a novel PD-1 inhibitor that may boost the immune system's response to cancer, potentially improving outcomes when paired with telisotuzumab adizutecan. These unique approaches could provide more effective treatment options for NSCLC patients.

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

Research has shown that the drug telisotuzumab adizutecan, when combined with a PD-1 immune checkpoint inhibitor like budigalimab, can help treat non-small cell lung cancer (NSCLC). This combination targets a protein called c-Met, which is often overly active in NSCLC and linked to worse outcomes. Early tests showed promising results for patients with advanced NSCLC using this drug pair. In this trial, some participants will receive telisotuzumab adizutecan with budigalimab.

Additionally, telisotuzumab adizutecan has been safely used with pembrolizumab, another PD-1 inhibitor, showing potential in reducing tumor activity. Other participants in this trial will receive telisotuzumab adizutecan with pembrolizumab. Overall, evidence suggests that these drug combinations could effectively manage NSCLC by specifically targeting cancer cells. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with advanced or metastatic non-squamous NSCLC who haven't had prior treatment for their advanced disease and have no actionable genomic alterations. They must have measurable disease, known PD-L1 status, adequate organ function, and may have had one systemic therapy if applicable.

Inclusion Criteria

My cancer can be measured by standard criteria.

My cancer's PD-L1 status is known.

My lung cancer is advanced or has spread and is not squamous cell type.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of Telisotuzumab Adizutecan in combination with budigalimab until a tolerable and efficacious dose is reached

Approximately 12 weeks

Regular visits for dose adjustments and monitoring

Dose Optimization

Participants receive optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or other treatment regimens

Up to 33 months

Frequent visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Budigalimab
• Pembrolizumab
• Telisotuzumab Adizutecan

Trial Overview The trial is testing Telisotuzumab Adizutecan combined with Budigalimab against standard treatments. It's in two stages: finding a safe dose of ABBV-400 with Budigalimab, then comparing different doses and combinations to the standard care involving Pembrolizumab, Pemetrexed, Carboplatin or Cisplatin.

How Is the Trial Designed?

Group I: Part 2: Standard of Care Experimental Treatment 4 Interventions

Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration.

Group II: Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab Experimental Treatment 2 Interventions

Participants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration.

Group III: Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab Experimental Treatment 2 Interventions

Participants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration.

Group IV: Part 1: Telisotuzumab Adizutecan + Budigalimab Experimental Treatment 2 Interventions

Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS8655

Temab-A) in combination with budigalimab in patients (pts) ... Addition of programmed cell death (ligand) 1 (PD-[L]1) inhibitors to chemotherapy (CT) has improved treatment of NSCLC regardless of PD-(L)1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06772623

NCT06772623 | Study to Evaluate Adverse Events and ... Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two ...

3. asco.org asco.org/videos-slides/VIDEOSANDSLIDES253437

Phase 1b/2 study evaluating telisotuzumab adizutecan ... Phase 1b/2 study evaluating telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with budigalimab in patients (pts) with advanced non-squamous (NSQ) non- ...

4. news.abbvie.com news.abbvie.com/2025-05-27-AbbVie-Features-New-Data-Across-Difficult-to-Treat-Solid-Tumors-and-Blood-Cancers-at-ASCO-2025,-Highlighting-Breadth-and-Depth-of-its-Oncology-Portfolio

AbbVie Features New Data Across Difficult-to-Treat Solid ... Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous ...

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-536

M24-536 Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult ...

6. researchstudies.cuanschutz.edu researchstudies.cuanschutz.edu/Study/25-0149

Find a Research Study The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/565695

Study to Evaluate Adverse Events and Efficacy of Intravenous ... The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in ...