Study to Assess Adverse Events and How Intravenously (IV) Infused ABBV-400 Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Phase 1b Study to Evaluate Safety and Pharmacokinetics (PK) of ABBV-400 in Chinese Subjects With Unresectable Locally Advanced/Metastatic Colorectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464692
• Other study ID #: M24-559
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 29, 2024
• Est. completion date: April 5, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and how ABBV-400 moves through the body of adult participants with unresectable locally advanced/metastatic CRC.

ABBV-400 is an investigational drug being developed for the treatment of CRC. Study doctors put the participants in cohorts called treatment arms. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Up to approximately 27 adult participants with unresectable locally advanced/metastatic CRC, will be enrolled in the study in approximately 10 sites in China.

In the dose escalation arms, participants will receive escalating doses of intravenously (IV) infused ABBV-400 dose A or B. In dose expansion arm part 1, participants will receive the optimal dose of IV infused ABBV-400. In dose expansion arm part 2, participants will receive the dose B of IV infused ABBV-400. The total study duration will be approximately 2.5 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: April 5, 2027
• Est. primary completion date: April 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

• Has histologically or cytologically confirmed unresectable advanced/metastatic colorectal cancer (mCRC).

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

• Does not harbor the BRAF V600E mutation and is not deficient mismatch repair (dMMR)+/microsatellite instability (MSI)-High.

• Expansion Part 2 only:

• Diagnosis of a malignant solid tumor by histology (World Health Organization [WHO] criteria).

• Measurable disease per RECIST v1.1.

• Advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophageal junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC), who have progressed on standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.

Exclusion Criteria:

• History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.

• Prior systemic regimen containing c-Met targeting antibody (e.g., amivantamab-vmjw, ABT-700) or define: antibody-drug conjugate (ADC). Tyrosine kinase inhibitors (TKIs) of Met are allowed.

• No availability of representative baseline tumor tissue (archived and/or fresh biopsy during screening phase), only applicable for participants enrolled in Stage 2.

• History of Interstitial lung disease (ILD)/pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.

• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.

• History of clinically significant, intercurrent lung-specific illnesses including, but not limited to:

• Underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, dependence on supplemental oxygen, etc.)

• Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) and prior pneumonectomy.

• No resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade <= 1 prior to study entry, except for neutropenia (Grade <= 2), peripheral neuropathy (Grade <= 2), and alopecia (any grade).

• Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy).

• 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 Overall Survival [OS] rate > 90%).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• ABBV-400
Intravenous (IV) Infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicity (DLT) of ABBV-400 in Stage 1	DLTs are defined as grade >= 3 thrombocytopenia that cannot clinically improve after adequate medical treatment/support, febrile neutropenia grade >= 3 or grade 4 neutropenia that cannot clinically improve after adequate medical treatment/support, and any grade 2 or higher interstitial lung disease (ILD)/pneumonitis that cannot clinically improve after adequate medical treatment/support.	Up to 24 Months
Primary	Maximum observed plasma or serum concentration (Cmax) of ABBV-400 Conjugate	Cmax of ABBV-400 conjugate.	Up to 24 Months
Primary	Time to Cmax (Tmax) of ABBV-400 Conjugate	Tmax of ABBV-400 conjugate.	Up to 24 Months
Primary	Area Under the Concentration-Time Curve (AUC) of ABBV-400 Conjugate	AUC of ABBV-400 conjugate.	Up to 24 Months
Primary	Total Antibody of ABBV-400	Total antibody of ABBV-400.	Up to 24 Months
Primary	Unconjugated Payload of ABBV-400	Unconjugated payload of ABBV-400.	Up to 24 Months
Secondary	Objective Response (OR)	OR as assessed by the Investigator: Confirmed complete response (CR) or confirmed partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.	Up to 24 Months
Secondary	Duration of Response (DoR)	DoR as assessed by Investigator: DoR is defined as the time from the participantt's initial response (CR or PR) to the first occurrence of radiographic progression or death from any cause.	Up to 24 Months
Secondary	Best Overall Response (BOR)	Disease control as assessed by the Investigator: BOR of confirmed CR or confirmed PR, or stable disease based on RECIST, version 1.1.	Up to 24 Months
Secondary	Progression-Free Survival (PFS)	PFS as assessed by Investigator: PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause, whichever occurs first.	Up to 24 Months
Secondary	Overall Survival (OS)	OS is defined as the time from the participant's first dose of study drug until death from any cause.	Up to 24 Months

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