A Study to Assess the Adverse Events and Change in Disease Activity of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Participants with Metastatic Colorectal Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Jul 2025 → ongoing

Decision date (initial)

2025-06-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy

1) To evaluate the efficacy of telisotuzumab adizutecan combinations as compared to standard of care treatment in Metastatic colorectal cancer (mCRC).
2) To evaluate the safety and tolerability of telisotuzumab adizutecan combinations.
3) To optimize the telisotuzumab adizutecan dose in combination regimens to determine the recommended Phase 3 dose (RP3D) in applicable substudies.

Secondary objectives 2

1. To evaluate additional efficacy endpoints of telisotuzumab adizutecan combinations in mCRC
2. To evaluate the pharmacokinetics (PK) of telisotuzumab adizutecan in combination regimens in mCRC.

Conditions and MedDRA coding

Metastatic Colorectal Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Substudy 1 and 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. Substudy 1 and 2: QTc < 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
3. Substudy 1 and 2: Participant has histologically or cytologically confirmed mCRC.
4. Substudy 1 and 2: Participant has measurable disease per RECIST v1.1.
5. Substudy 2: Left sided primary tumor

Exclusion criteria 4

1. Substudy 1 and 2: Prior systemic therapy for mCRC.
2. Substudy 1 and 2: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis that required treatment with systemic steroids, or idiopathic pneumonitis.
3. Substudy 1 and 2: History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%).
4. Substudy 2: History of treatment with any anti-EGFR treatments (cetuximab or panitumumab).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.

Secondary endpoints 4

1. Substudy 1 and 2: Progression-Free Survival as assessed by the investigator: PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
2. Substudy 1 and 2: DOR as assessed by the investigator: The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. DOR is defined for subjects with confirmed CR/PR.
3. Substudy 1 and 2: Overall survival: defined as the time from first dose of study treatment to the event of death from any cause.
4. Substudy 1 and 2: Disease Control as assessed by the investigator: best overall response of confirmed CR or confirmed PR, or Stable Disease (SD) based on RECIST, version 1.1 as determined by the investigator.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 6

Locations

6 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 56 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications