A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients With Select, Relapsed or Refractory Hematologic Malignancies
CAL-101, an oral inhibitor of PI3Kδ, is being evaluated for its safety, pharmacokinetics, pharmacodynamics, and clinical activity in patients with relapsed or refractory hematologic malignancies, including CLL, B-cell NHL, AML, and MM. The study's completion in August 2012 positions Gilead Sciences to leverage potential market opportunities in the oncology space, particularly in indications with high unmet medical needs. The competitive landscape includes other PI3K inhibitors, such as idelalisib, which may impact market entry strategies and pricing. Diligence should focus on the drug's safety profile and efficacy data to assess its potential for regulatory approval and market uptake.
Indication: Chronic Lymphocytic Leukemia (CLL)
Modality: small molecule
Target: Phosphatidylinositol 3-kinase delta (PI3Kδ)
Sponsor: Gilead Sciences
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jun 25, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Phosphatidylinositol 3-kinase delta (PI3Kδ)
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Condition raw: Chronic Lymphocytic Leukemia (CLL), Lymphoma, Non-Hodgkin (NHL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM)
Condition normalized: Chronic Lymphocytic Leukemia (CLL), Lymphoma, Non-Hodgkin (NHL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM)
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Phosphatidylinositol 3-kinase delta (PI3Kδ)
Target normalized: Phosphatidylinositol 3-kinase delta (PI3Kδ)