Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame
Primary	To determine the dose limiting toxicities (DLTs) of oral CB-5083 in subjects with lymphoid hematological malignancies	Dose Escalation Stage - the first 28 days of treatment (Cycle 1) with CB-5083
Primary	To determine the pharmacokinetic (PK) profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the AUC	Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 in the second 28 days (Cycle 2) of treatment with CB-5083
Primary	To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmax	Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Primary	To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmin	Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Primary	To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Tmax	Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Primary	To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the T1/2	Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Primary	To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed and refractory Multiple Myeloma at the maximum tolerated dose (MTD) at the end of the Dose Escalation Stage	Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment
Primary	To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed/refractory DLBCL or Waldenstrom Macroglobulinemia at the MTD	Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment
Secondary	To assess the pharmacodynamic (PD) effects of CB-5083 in peripheral blood cells and cancer cells	Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1
Secondary	To further asses the PK profile of oral CB-5083 in subjects by measuring the AUC	Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Secondary	To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmax	Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Secondary	To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmin	Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Secondary	To further asses the PK profile of oral CB-5083 in subjects by measuring the Tmax	Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Secondary	To further asses the PK profile of oral CB-5083 in subjects by measuring the T1/2	Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
Secondary	To evaluate preliminary efficacy of oral CB-5083 in subjects, using standard response criteria	Dose Expansion Stages - at the end of each 28 day cycle of treatment
Other	To assess the predictive value of potential baseline biomarkers for clinical trial subject enrichment strategies	Dose Expansion Stages - within 28 days before day 1 of Cycle 1

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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