Telisotuzumab Adizutecan + Combination Therapy for Colorectal Cancer

(AndroMETa-CRC Trial)

Recruiting at 53 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: c-Met agents, Topoisomerase inhibitors

Disqualifiers: Other malignancies, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for metastatic colorectal cancer (mCRC) to evaluate its safety and effectiveness. The trial combines an investigational drug, telisotuzumab adizutecan, with existing chemotherapy drugs to determine if it can improve patient outcomes. Participants will receive varying doses to identify the optimal one, then join one of three treatment groups for further study. The trial seeks participants with mCRC who can perform daily activities with minimal assistance. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information 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.

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

Research has shown that telisotuzumab adizutecan is generally safe for patients. In studies, researchers tested this experimental drug alongside other treatments for colorectal cancer (CRC). Results suggest that patients typically tolerated the drug well, with manageable side effects.

Although specific side effects weren't listed, ongoing research indicates that telisotuzumab adizutecan shows promise against tumors. This suggests that its potential benefits might outweigh the risks for some patients. It is important to note that this drug remains under investigation in clinical trials and is not yet approved for general use. Participants in these trials help researchers learn more about the safety and effectiveness of this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Telisotuzumab adizutecan is unique because it targets a specific protein, c-Met, that is often overactive in colorectal cancer cells. This targeted approach could potentially lead to more effective treatment by directly inhibiting cancer growth, unlike traditional chemotherapy options like FOLFOX, which broadly attack rapidly dividing cells. Researchers are excited about this treatment because it combines with existing drugs like 5-FU and panitumumab, which could enhance its effectiveness and offer a more comprehensive attack on the cancer cells. By focusing on specific molecular targets, telisotuzumab adizutecan may offer a precision medicine approach, potentially improving outcomes and reducing side effects compared to current standard treatments.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research shows that telisotuzumab adizutecan may help treat colorectal cancer, especially in patients with high levels of the protein c-Met. In this trial, participants will receive telisotuzumab adizutecan in various doses and combinations as part of different treatment arms. Studies have found that this treatment can lead to better response rates and longer periods without disease progression. It has shown promise even in patients with different genetic backgrounds. Recent findings highlight its progress in targeting solid tumors, including colorectal cancer. Overall, researchers are carefully studying this treatment for its potential benefits in managing the disease. ^{1 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with metastatic colorectal cancer (mCRC) who have measurable disease, are in good physical condition (ECOG status of 0 or 1), and meet specific laboratory criteria. It's not suitable for those who don't fit these requirements.

Inclusion Criteria

Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Laboratory values meeting the criteria within the protocol

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had any other cancers in the last 5 years, except for those unlikely to spread.

I have been treated with drugs targeting c-Met or topoisomerase inhibitors.

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 with FOLFOX and bevacizumab or 5FU/LV and panitumumab until a tolerable and efficacious dose is reached.

Up to 24 weeks

Regular visits (in-person)

Dose Optimization

Participants receive one of two optimized doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab.

Up to 22 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Telisotuzumab Adizutecan

Trial Overview The study tests a new drug, Telisotuzumab Adizutecan, combined with chemotherapy drugs FOLFOX and either Bevacizumab or Panitumumab. Participants will first receive increasing doses to find the safest effective amount, then be randomly assigned to treatment groups.

How Is the Trial Designed?

Group I: Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose Experimental Treatment 4 Interventions

Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

Group II: Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose Experimental Treatment 4 Interventions

Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

Group III: Substudy 2: Dose Expansion Compatator Experimental Treatment 4 Interventions

Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.

Group IV: Substudy 2: Dose Escalation Telisotuzumab Adizutecan Experimental Treatment 4 Interventions

Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration.

Group V: Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose Experimental Treatment 5 Interventions

Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Group VI: Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose Experimental Treatment 5 Interventions

Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Group VII: Substudy 1: Dose Expansion Compatator Experimental Treatment 4 Interventions

Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Group VIII: Substudy 1: Dose Escalation Telisotuzumab Adizutecan Experimental Treatment 5 Interventions

Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year 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. onclive.com onclive.com/view/effectively-targeting-c-met-in-colorectal-cancer-is-becoming-a-reality-with-novel-approaches

Effectively Targeting c-Met in Colorectal Cancer Is ... Telisotuzumab adizutecan shows potential in CRC, with improved response rates and progression-free survival, especially in high c-Met expression ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.258

Genomic alterations in circulating tumor DNA (ctDNA) and ... Telisotuzumab adizutecan has promising efficacy. RRs were seen in CRC pts with heterogeneous genomic profiles, including pts positive for actionable biomarkers ...

3. news.abbvie.com news.abbvie.com/2025-10-13-AbbVie-to-Present-New-Data-at-ESMO-2025-Reinforcing-Leadership-in-Advancing-Targeted-Therapies-for-Solid-Tumors

AbbVie to Present New Data at ESMO 2025 Reinforcing ... New data from telisotuzumab adizutecan (Temab-A) and ABBV-706 across pancreatic, colorectal, and solid tumors, highlight progress in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06820463

NCT06820463 | A Study to Evaluate the Adverse Events ... The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, ...

5. gioncologynow.com gioncologynow.com/post/esmo-research-highlights-niche-2-and-foxtrot-telisotuzumab-adizutecan-and-more

ESMO Research Highlights: NICHE-2 and FOxTROT ... Overall survival improved modestly, 10.9 versus 9.4 months, with a hazard ratio of 0.8.

6. onclive.com onclive.com/view/telisotuzumab-adizutecan-delivers-early-signals-of-antitumor-activity-in-crc

Telisotuzumab Adizutecan Delivers Early Signals of ... John H. Strickler, MD, discusses treatment with telisotuzumab adizutecan for CRC as well as this ADC's potential to broaden the CRC treatment paradigm.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS3635

Temab-A) monotherapy vs trifluridine/tipiracil plus ... Telisotuzumab adizutecan (ABBV-400; Temab-A) monotherapy vs trifluridine/tipiracil plus bevacizumab in patients with refractory metastatic ...

8. asco.org asco.org/abstracts-presentations/ABSTRACT485886

Temab-A) monotherapy vs trifluridine/tipiracil plus ... Preliminary data from the ongoing first-in-human study of Temab-A (NCT05029882) indicate a tolerable safety profile and promising antitumor activity in patients ...

9. 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 ...