Phase 1 Study of ABBV-CLS-484 Alone and With PD-1 Inhibitor or VEGFR TKI in Adults With Advanced or Metastatic Tumors

What this Trial Is About

Researchers are evaluating ABBV-CLS-484, a drug being studied alone and in combination with other cancer therapies, for people with advanced solid tumors. This phase 1 trial aims to find a safe and effective dose of ABBV-CLS-484 as a single treatment and combined with a PD-1 targeting agent or a VEGFR tyrosine kinase inhibitor. The study includes patients with locally advanced or metastatic tumors, including head and neck squamous cell carcinoma, non-small cell lung cancer, and clear cell renal cell carcinoma. The trial has three parts. In Part 1, ABBV-CLS-484 is given alone in increasing doses to patients with advanced solid tumors. Part 2 tests escalating doses of ABBV-CLS-484 combined with either a PD-1 inhibitor or a VEGFR tyrosine kinase inhibitor in similar patients. Part 3 involves giving ABBV-CLS-484 at the recommended dose alone or with these agents to patients with specific advanced cancers. Treatments are given as oral capsules for ABBV-CLS-484 and VEGFR TKI, and intravenous infusion for the PD-1 inhibitor. Participants will undergo various assessments, including measuring drug levels in the blood, monitoring for side effects, and evaluating tumor response using established criteria. The study follows patients from baseline through approximately 42 to 64 days for dose escalation and up to about three years for longer-term response. The research team will carefully observe safety, drug behavior, and how the tumors respond to the treatments during the study period.

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