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A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients

Primary Purpose

P1b: Advanced Solid Tumors, P2: Biliary Tract Cancer

Status

Recruiting

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CTX-009 (ABL001)

Paclitaxel

Irinotecan

About this trial

This is an interventional treatment trial for P1b: Advanced Solid Tumors focused on measuring VEGF, DLL4, Solid Tumors, Bispecific antibody, anti-angiogenic

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
P2 only: Patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma)
P2 only: Patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy, including treatment with gemcitabine in combination with a platinum agent
Patients aged 19 years or older
At least one lesion measurable defined by response evaluation criteria in solid tumors (RECIST) version 1.1.
Life expectancy ≥ 12 weeks
ECOG performance status 0 or 1
Women of childbearing potential must have a negative pregnancy test outcome
Patients must provide written informed consent to voluntary participation in this study

Key Exclusion Criteria:

History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel
Less than 4 weeks have elapsed since a surgery
History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina
Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy
Severe infections or major and unhealed injury (active ulcer, untreated fracture)
Symptomatic or uncontrolled central nervous system (CNS) metastasis
Pregnant or lactating women or patients planning to become pregnant during the study
Participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment
Administration of antiplatelets or anticoagulants within 2 weeks prior to screening
Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
HIV or other severe diseases that warrant the exclusion from this study

Sites / Locations

Seoul National University Bundang HospitalRecruiting
Asan Medical CenterRecruiting
Samsung Medical CenterRecruiting
Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CTX-009 (ABL001) and Paclitaxel (P1b)

CTX-009 (ABL001) and Irinotecan (P1b)

CTX-009 (ABL001) and Paclitaxel (P2)

Arm Description

1 cycle = 4weeks

Outcomes

Primary Outcome Measures

P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)

Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects

P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC

The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review

Secondary Outcome Measures

Adverse Events (AEs)

Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Pharmacokinetics (PK) of CTX-009 (ABL001)

Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)

Objective response rate (ORR)

Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review

Disease control rate (DCR)

Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)

Time to treatment failure (TTF)

Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first

Duration of response (DOR)

Time interval from first occurrence of a documented objective response to the time of disease progression

Progression-free survival (PFS)

The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death

P2: Survival rate

The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment

P2: Overall survival (OS)

Time from the initiation of treatment to death

Full Information

NCT ID

NCT04492033

First Posted

June 15, 2020

Last Updated

June 26, 2022

Sponsor

Handok Inc.

Collaborators

Compass Therapeutics, ABL Bio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04492033

Brief Title

A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients

Official Title

A Phase 1b/2a Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 22, 2020 (Actual)

Primary Completion Date

August 31, 2024 (Anticipated)

Study Completion Date

July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Handok Inc.

Collaborators

Compass Therapeutics, ABL Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.

Detailed Description

Phase 1b Study: Indication of phase 1b study is the advanced or metastatic solid tumors (including, but not limited to, colorectal cancer, gastric cancer, and ovarian cancer). Phase 2 Study: Indication of phase 2 study is unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

P1b: Advanced Solid Tumors, P2: Biliary Tract Cancer

Keywords

VEGF, DLL4, Solid Tumors, Bispecific antibody, anti-angiogenic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CTX-009 (ABL001) and Paclitaxel (P1b)

Arm Type

Experimental

Arm Title

CTX-009 (ABL001) and Irinotecan (P1b)

Arm Type

Experimental

Arm Description

1 cycle = 4weeks

Arm Title

CTX-009 (ABL001) and Paclitaxel (P2)

Arm Type

Experimental

Arm Description

1 cycle = 4weeks

Intervention Type

Drug

Intervention Name(s)

CTX-009 (ABL001)

Intervention Description

CTX-009 (ABL001) will be administered biweekly.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Paclitaxel will be administered weekly.

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

Irinotecan will be administered biweekly.

Primary Outcome Measure Information:

Title

P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)

Description

Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects

Time Frame

From Day 1 until disease progression or Day 28, whichever came first

Title

P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC

Description

The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review

Time Frame

Up to approximately 24 months

Secondary Outcome Measure Information:

Title

Adverse Events (AEs)

Description

Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame

Up to approximately 24 months

Title

Pharmacokinetics (PK) of CTX-009 (ABL001)

Description

Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)

Time Frame

Up to approximately 24 months

Title

Objective response rate (ORR)

Description

Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review

Time Frame

Up to approximately 24 months

Title

Disease control rate (DCR)

Description

Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)

Time Frame

Up to approximately 24 months

Title

Time to treatment failure (TTF)

Description

Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first

Time Frame

Up to approximately 24 months

Title

Duration of response (DOR)

Description

Time interval from first occurrence of a documented objective response to the time of disease progression

Time Frame

Up to approximately 24 months

Title

Progression-free survival (PFS)

Description

The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death

Time Frame

Up to approximately 24 months

Title

P2: Survival rate

Description

The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment

Time Frame

6 months and 12 months

Title

P2: Overall survival (OS)

Description

Time from the initiation of treatment to death

Time Frame

Up to approximately 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors P2 only: Patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma) P2 only: Patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy, including treatment with gemcitabine in combination with a platinum agent Patients aged 19 years or older At least one lesion measurable defined by response evaluation criteria in solid tumors (RECIST) version 1.1. Life expectancy ≥ 12 weeks ECOG performance status 0 or 1 Women of childbearing potential must have a negative pregnancy test outcome Patients must provide written informed consent to voluntary participation in this study Key Exclusion Criteria: History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel Less than 4 weeks have elapsed since a surgery History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy Severe infections or major and unhealed injury (active ulcer, untreated fracture) Symptomatic or uncontrolled central nervous system (CNS) metastasis Pregnant or lactating women or patients planning to become pregnant during the study Participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment Administration of antiplatelets or anticoagulants within 2 weeks prior to screening Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids HIV or other severe diseases that warrant the exclusion from this study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

SeungJi Yoo

Phone

+82-2-527-5413

SeungJi.Yoo@handok.com

First Name & Middle Initial & Last Name or Official Title & Degree

HyunJoo Son

Phone

+82-2-527-5257

HyunJoo.Son@handok.com

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Won Kim

First Name & Middle Initial & Last Name & Degree

Keun-Wook Lee

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kyu-Pyo Kim

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joon Oh Park

First Name & Middle Initial & Last Name & Degree

Jeeyun Lee

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Do-Yeon Oh (Coordinating Investigator)

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients

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