ABBV-CLS-484
DrugOral Capsule
NCT Number: NCT04777994
The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).
The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).
Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.
Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors.
Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Institut Paoli-Calmettes /ID# 260956, Marseille, Bouches-du-Rhone, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Monotherapy and Combination Dose Escalation:
For Monotherapy Dose Expansion only:
For PD-1 Targeting Agent Combination Dose Expansion only:
For VEGFR TKI Combination Dose Expansion only:
Exclusion criteria
Oral Capsule
Oral Tablet
Intravenous (IV) infusion
Time frame: Baseline Up to Approximately Day 42
Maximum plasma/serum concentration of ABBV-CLS-484
Time frame: Baseline Up to Approximately Day 64
Maximum plasma/serum concentration of PD-1 inhibitor
Time frame: Baseline Up to Approximately Day 64
Maximum plasma/serum concentration of PD-1 inhibitor
Time frame: Baseline Up to Approximately Day 42
The amount of time taken to reach Cmax
Time frame: Baseline Up to Approximately Day 64
The amount of time taken to reach Cmax
Time frame: Baseline Up to Approximately Day 64
The amount of time taken to reach Cmax
Time frame: Baseline Up to Approximately Day 42
Terminal phase elimination half-life (t1/2)
Time frame: Baseline Up to Approximately Day 64
Terminal phase elimination half-life (t1/2)
Time frame: Baseline Up to Approximately Day 64
Terminal phase elimination half-life (t1/2)
Time frame: Baseline Up to Approximately Day 42
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time frame: Baseline Up to Approximately Day 64
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time frame: Baseline Up to Approximately Day 64
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time frame: Baseline Up to Approximately Day 42
The MTD and/or RP2D of ABBV-CLS-484 will be determined during the monotherapy therapy dose escalation phase of the study
Time frame: Baseline Up to Approximately Day 64
The MTD and/or RP2D of ABBV-CLS-484 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Time frame: Baseline Up to Approximately Day 64
The MTD and/or RP2D of ABBV-CLS-484 and VEGFR TKI will be determined during the combination therapy dose escalation phase of the study
Time frame: Baseline Up to Approximately Day 42
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time frame: Baseline Up to Approximately Day 64
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time frame: Baseline Up to Approximately Day 64
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time frame: Baseline through Study Completion (approximately 3 years)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time frame: Baseline through Study Completion (approximately 3 years)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time frame: Baseline through Study Completion (approximately 3 years)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Contact information is provided by the study sponsor or research team.
Calico Life Sciences LLC
Industry
A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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