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

• Sponsor: Handok Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04492033
• Collaborator: Compass Therapeutics (Industry), ABL Bio, Inc. (Industry)
• Enrollment: 92
• Locations: 4
• Arms: 3
• Anticipated Duration (Months): 61.3
• Patients Per Site: 23
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
P1b: Advanced Solid Tumors; P2: Biliary Tract Cancer	Drug: CTX-009 (ABL001); Drug: Paclitaxel; Drug: Irinotecan	Phase 1/Phase 2

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 92 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 22, 2020
• Anticipated Primary Completion Date: Aug 31, 2024
• Anticipated Study Completion Date: Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTX-009 (ABL001) and Paclitaxel (P1b)	Drug: CTX-009 (ABL001); CTX-009 (ABL001) will be administered biweekly.; Drug: Paclitaxel; Paclitaxel will be administered weekly.
Experimental: CTX-009 (ABL001) and Irinotecan (P1b) 1 cycle = 4weeks	Drug: CTX-009 (ABL001); CTX-009 (ABL001) will be administered biweekly.; Drug: Irinotecan; Irinotecan will be administered biweekly.
Experimental: CTX-009 (ABL001) and Paclitaxel (P2) 1 cycle = 4weeks	Drug: CTX-009 (ABL001); CTX-009 (ABL001) will be administered biweekly.; Drug: Paclitaxel; Paclitaxel will be administered weekly.

Outcome Measures

Primary Outcome Measures

1. P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT) [From Day 1 until disease progression or Day 28, whichever came first]

   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

2. P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC [Up to approximately 24 months]

   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

1. Adverse Events (AEs) [Up to approximately 24 months]

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

2. Pharmacokinetics (PK) of CTX-009 (ABL001) [Up to approximately 24 months]

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

3. Objective response rate (ORR) [Up to approximately 24 months]

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

4. Disease control rate (DCR) [Up to approximately 24 months]

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

5. Time to treatment failure (TTF) [Up to approximately 24 months]

   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

6. Duration of response (DOR) [Up to approximately 24 months]

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

7. Progression-free survival (PFS) [Up to approximately 24 months]

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

8. P2: Survival rate [6 months and 12 months]

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

9. P2: Overall survival (OS) [Up to approximately 24 months]

   Time from the initiation of treatment to death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of
2	Asan Medical Center	Seoul		Korea, Republic of
3	Samsung Medical Center	Seoul		Korea, Republic of
4	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Handok Inc.
• Compass Therapeutics
• ABL Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Handok Inc.
• ClinicalTrials.gov Identifier: NCT04492033
• Other Study ID Numbers: ABL001-P1bC; CTX-009-001
• First Posted: Jul 30, 2020
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Handok Inc.: VEGF; DLL4; Solid Tumors; Bispecific antibody; anti-angiogenic
• Additional relevant MeSH terms: Biliary Tract Neoplasms; Paclitaxel; Irinotecan

Study Results

No Results Posted as of Jun 30, 2022