A Phase 1 Study With ABBV-CLS-484 in Subjects With Locally Advanced or Metastatic Tumors
Status:
Recruiting
Trial end date:
2024-02-22
Target enrollment:
Participant gender:
Summary
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. 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 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 agent in
subjects with locally advanced or metastatic, relapsed or refractory gastric or GEJ
adenocarcinoma.