TerminatedPhase 1

A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions

Stopped: Study terminated prematurely due to internal corporate decision

United States11 participantsStarted 2021-01-19

Plain-language summary

A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ECOG performance status of 0 or 1 * Must have disease that is considered non-surgically resectable. * Relapsed or persistent/refractory to at least two prior systemic treatment regimens for locally advanced or metastatic disease considered to be standard-of-care (SOC). * Must have previously received an irinotecan or oxaliplatin-based therapy, as well as a targeted antibody therapy for metastatic disease * Tumors that are MSI-H/dMMR must have previously received checkpoint inhibitor therapy * Adequate hepatic function * Adequate renal function * Normal coagulation panel * Willingness to use effective contraception Exclusion Criteria: * Current or history of CNS metastases * Significant cardiovascular disease * Pregnant or breastfeeding

What they're measuring

Determine the Number of Patients With Dose Limiting Toxicities (DLTs)

Timeframe: Until disease progression, or up to approximately 15 months and 18 days, whichever is first

Maximum Concentration (Cmax) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Time-to-maximum Concentration (Tmax) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Area Under the Curve (AUC) From Time Zero to 24 hr (AUC0-24) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15 (Cycle duration is 21 days)

AUC From Time Zero to Time Infinity (AUC0-ꝏ) of APR003

Timeframe: Cycle 1 Day 1 (Cycle duration is 21 days)

AUC Over the Dosing Interval (AUClast) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Elimination Half-life (T1/2) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Trial details

NCT IDNCT04645797

SponsorApros Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-07

Results submitted2023-12-29

View on ClinicalTrials.gov More Advanced Colorectal Carcinoma trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determine the Number of Patients With Dose Limiting Toxicities (DLTs)

Timeframe: Until disease progression, or up to approximately 15 months and 18 days, whichever is first

Maximum Concentration (Cmax) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Time-to-maximum Concentration (Tmax) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Area Under the Curve (AUC) From Time Zero to 24 hr (AUC0-24) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15 (Cycle duration is 21 days)

AUC From Time Zero to Time Infinity (AUC0-ꝏ) of APR003

Timeframe: Cycle 1 Day 1 (Cycle duration is 21 days)

AUC Over the Dosing Interval (AUClast) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Elimination Half-life (T1/2) of APR003

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)