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Venetoclax

Dose escalation cohorts of ABBV-075 monotherapy

Expansion cohorts of ABBV-075 and venetoclax combination therapy

Expansion cohorts of ABBV-075 monotherapy

ABBV-075

AbbVie Inc.

This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.

A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer

Maximum tolerated dose is defined as the highest dose level at which less than 2 of 6 participants experience the same dose limiting toxicity. If more than 2 participants experience a different dose limiting toxicity, the maximum tolerated dose may be further evaluated or determined to be exceeded based on discussions with the investigators and medical monitors.

Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t).

DOR is defined as the time from the participant's initial CR or PR to the time of disease progression

ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).

PFS is defined as the time from the first dose of ABBV-075 to either disease progression or death, whichever occurs first.

AbbVie

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer	NCT02391480	Cancer Breast Cancer Non-Small Cell ... Acute Myeloid L... Multiple Myelom... Prostate Cancer Small Cell Lung... Non-Hodgkins Ly...	ABBV-075 Venetoclax	18 Years -	AbbVie
A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer	NCT02391480	Cancer Breast Cancer Non-Small Cell ... Acute Myeloid L... Multiple Myelom... Prostate Cancer Small Cell Lung... Non-Hodgkins Ly...	ABBV-075 Venetoclax	18 Years -	AbbVie

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