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A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous ABBV-253 Moves Through the Body in Adult Participants With Advanced Solid Tumors

ConditionsAdvanced Solid TumorsNon-Small Cell Lung CancerColorectal CancerPancreatic Ductal AdenocarcinomaGastric CancerGastroesophageal Junction AdenocarcinomaBiliary Tract CancerHead and Neck Squamous Cell CarcinomaOvarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbVie

About this trial

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events, change in disease activity and pharmacokinetics of ABBV-253.

ABBV-253 is an investigational drug being developed for the treatment of advanced solid tumors. This open-label study consists of two parts. In Part 1 (ABBV-253 dose escalation), participants with any of the eligible cancer types will receive 1 of 4 (or more) doses of ABBV-253. Each cohort receives a higher dose, lower dose, or the same dose of ABBV-253 than the previous group. In Part 2 (ABBV-253 dose optimization), a new group of participants with NSCLC will be randomly put into pre-determined dose groups to receive 1 of 3 doses of ABBV-253. Approximately 130 participants will be enrolled in the study at approximately 11 sites worldwide.

Participants will receive intravenous (IV) infusion of ABBV-253, as part of the 4 year study.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Part 1 monotherapy dose escalation only: Participants with a diagnosis of a malignant solid tumor by histology (WHO criteria), including, but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), PDAC, gastroesophageal adenocarcinoma (GEA), ovarian cancer (OC), and biliary tract cancer (BTC)

ECOG performance status of 0 or 1

Participants with evaluable and measurable disease per RECIST Version 1.1.

Disqualifiers

No known active disease present within 3 years prior to first dose of study treatment and felt to be at low risk of recurrence by the treating investigator.

Adequately treated in situ carcinoma without evidence of disease.

Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin without evidence of disease.

Participants with ovarian cancer with histologies other than high grade serous ovarian cancer including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ABBV-253

    Drug

    Infusion

Treatment groups

130 Participants
are divided into 4 treatment groups
Group A: Part 1: ABBV-253 Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose Optimization - ABBV-253 Dose AExperimental treatment 1 intervention
Group C: Part 2: Dose Optimization - ABBV-253 Dose BExperimental treatment 1 intervention
Group D: Part 2: Dose Optimization - ABBV-253 Dose CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Safety will be evaluated based upon the assessment of all-grade AEs, and SAEs reported during the treatment-emergent period, as well as clinical laboratory parameters (e.g., hematology, chemistry), vital sign measurements, and ECG results.

Time frame
Up to approximately 4 years
2

Number of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results

Number of participants with abnormal change in clinical laboratory test results like hematology and chemistry will be assessed.

Time frame
Up to approximately 4 years
3

Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Time frame
Up to approximately 4 years
4

Number of Participants with Change from Baseline in Electrocardiogram (ECG)

12-lead resting ECG will be recorded.

Time frame
Up to approximately 4 years

Secondary outcomes

1

Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-253, ADC, total antibody, and payload

Cmax of ABBV-253 ADC, total antibody, and payload

Time frame
Up to approximately 1 year
2

Time to Maximum Serum/Plasma Concentration (Tmax) of ABBV-253

Tmax of ABBV-253

Time frame
Up to approximately 1 year
3

Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-253 ADC, total antibody, and payload

AUC of ABBV-253 ADC, total antibody, and payload

Time frame
Up to approximately 1 year
4

Terminal Half-Life (t1/2) of ABBV-253 ADC, total antibody, and payload

t1/2 of ABBV-253 ADC, total antibody, and payload

Time frame
Up to approximately 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AbbVie

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: