Health TrialsbyHealthPanel

Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors

ConditionAdvanced Solid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCalico Life Sciences LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must weigh at least 35 kilograms (kg).

An Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

Life expectancy of >= 12 weeks.

Laboratory values meeting protocol criteria.

Disqualifiers

Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy)

Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.

Unresolved Grade 2 or higher peripheral neuropathy.

History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABBV-CLS-484

    Drug

    Oral Capsule

  • Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)

    Drug

    Oral Tablet

  • Programmed Cell Death-1 (PD-1) Inhibitor

    Drug

    Intravenous (IV) infusion

Treatment groups

248 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Combination Dose Escalation with PD-1 InhibitorExperimental treatment 2 interventions
Group C: Monotherapy ExpansionExperimental treatment 1 intervention
Group D: Combination Expansion with PD-1 InhibitorExperimental treatment 2 interventions
Group E: Combination Dose Escalation with VEGFR TKIExperimental treatment 2 interventions
Group F: Combination ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-484 (Monotherapy)

Maximum plasma/serum concentration of ABBV-CLS-484

Time frame
Baseline Up to Approximately Day 42
2

Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor (Combination therapy)

Maximum plasma/serum concentration of PD-1 inhibitor

Time frame
Baseline Up to Approximately Day 64
3

Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFRTKI (Combination therapy) Maximum plasma/serum concentration of PD-1 inhibitor

Maximum plasma/serum concentration of PD-1 inhibitor

Time frame
Baseline Up to Approximately Day 64
4

Dose Escalation: Time To Cmax (Tmax) Of ABBV-CLS-484 (Monotherapy)

The amount of time taken to reach Cmax

Time frame
Baseline Up to Approximately Day 42

Secondary outcomes

1

Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On (RECIST) v1.1 (Monotherapy)

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)
2

Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)

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)
3

Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)

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)

Other outcomes

Sponsors and contacts

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

Calico Life Sciences LLC

Lead sponsor

Source ClinicalTrials.gov
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