CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off

CRLX301

Elizabeth Dees, MD

A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and then enrollment into Phase 2a expansion cohorts will be initiated.

Phase 1 is an open-label, dose-escalation protocol. It is anticipated that up to 36 patients will be enrolled in Phase 1. All patients will be assigned to treatment with CRLX301 as the single agent.

For the first 2 cohorts a 1+5 study design will be utilized. A single patient will be enrolled sequentially into cohort 1 and cohort 2. If either patient in cohort 1 or 2 experiences a dose limiting toxicity (DLT) during Cycle 1, then the cohort will be expanded to enroll additional patients up to a total of 6.

As of cohort 3 and for all subsequent cohorts, a 3+3 dose escalation schema will be utilized.

MTD/RP2D will be determined at the dose level when \<2 of 6 patients experience a DLT in a cohort.

The Phase 2a part of the study will be an open-label expansion cohort study. An additional 24 patients with advanced, histologically confirmed solid tumor malignancies will be enrolled. All patients will be assigned to treatment at the MTD/RP2D with CRLX301 as the single agent.

All patients will be followed for safety, tumor response, and progression free survival (PFS) all per RECIST version 1.1 guidelines. Patients will remain on study treatment until they experience progression of disease, unacceptable toxicity, or other specified reason for discontinuation.

Phase 1 dose escalation study followed by phase 2a expansion cohort

Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors

Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumor Malignancies

Determination of MTD is dependent upon number of dose limiting toxicities and significant adverse events observed.

Safety variables will include AEs, SAEs, Severe AEs, Related AEs and AEs leading to Discontinuation in phase 2a subjects.

Area under the concentration vs time curve of released docetaxel in blood and/or urine specimens of patients receiving at least 1 dose of CRLX301.

Best overall tumor response will be provided per dose cohort using RECIST 1.1

NewLink Genetics Corporation

CRLX301 7.5 mg/m2 IV given every 3 weeks

CRLX301

Schedule 1 Cohort 1

CRLX301 15 mg/m2 IV given every 3 weeks

CRLX301

Schedule 1 Cohort 2

CRLX301 30 mg/m2 IV given every 3 weeks

CRLX301

Schedule 1 Cohort 3

CRLX301 60 mg/m2 IV given every 3 weeks

CRLX301

Schedule 1 Cohort 5

CRLX301 75 mg/m2 IV given every 3 weeks

CRLX301

Schedule 1 Cohort 6

CRLX301 90 mg/m2 IV given every 3 weeks

CRLX301

Schedule 1 Cohort 7

CRLX301 25 mg/m2 IV given weekly

CRLX301

Schedule 2 Cohort 1

CRLX301 35 mg/m2 IV given weekly

CRLX301

Schedule 2 Cohort 2

CRLX301 45 mg/m2 IV given weekly

CRLX301

Schedule 2 Cohort 3

CRLX301 54 mg/m2 IV given weekly

CRLX301

Schedule 2 Cohort 4

CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off

CRLX301

Schedule 2 Cohort 5

CRLX301 75mg/m2 IV given every 3 weeks

CRLX301

Phase 2a Expansion Cohort

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Primary Site of Disease at Study Entry

Patients were assessed by systemic assessment using the ECOG performance scale. All patients had to be 0 or 1 for inclusion in the study. ECOG performance score of 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG performance score of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, etc.

Baseline ECOG Status

Baseline BMI (kg/m^2)

Manager, Clinical Operations

At least one TEAE

At least one Serious TEAE

At least one DLT

At least one severe TEAE

At least one related TEAE

At least one TEAE leading to discontinuation

The phase 1 safety population were analyzed for dose limiting toxicities and treatment emergent adverse events. Treatment totals include all patients that received the specific dose at any point during the study.

Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities

The safety population (all patients) were analyzed for dose limiting toxicities and treatment emergent adverse events. Treatment totals include all patients that received the specific dose at any point during the study.

Number of Phase 2a Participants With Adverse Events as a Measure of Safety and Tolerability

Evaluate the Pharmacokinetic (PK) Profile of CRLX301

Complete Response

Partial Response

Stable Disease

Progressive Disease

Not Evaluated

All patients treated on study (safety population) were evaluated for overall tumor response.

Spots Global Cancer Trial Database for crlx301

Every month we try and update this database with for crlx301 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for crlx301

Every month we try and update this database with for crlx301 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for crlx301 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.