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

NCT04492033 | Terminated Phase 1 FDA Drug

• 2 other identifiers: ABL001-P1bCCTX-009-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

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.

Conditions

P1b: Advanced Solid Tumors; P2: Biliary Tract Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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

  Up to approximately 24 months

Secondary Outcomes (9)

• Adverse Events (AEs)

  Up to approximately 24 months

• Pharmacokinetics (PK) of CTX-009 (ABL001)

  Up to approximately 24 months

• Objective response rate (ORR)

  Up to approximately 24 months

• Disease control rate (DCR)

  Up to approximately 24 months

• Time to treatment failure (TTF)

  Up to approximately 24 months

Study Arms (3)

CTX-009 (ABL001) and Paclitaxel (P1b)

EXPERIMENTAL

Drug: CTX-009 (ABL001); Drug: Paclitaxel

CTX-009 (ABL001) and Irinotecan (P1b)

EXPERIMENTAL

1 cycle = 4weeks

Drug: CTX-009 (ABL001); Drug: Irinotecan

CTX-009 (ABL001) and Paclitaxel (P2)

EXPERIMENTAL

1 cycle = 4weeks

Drug: CTX-009 (ABL001); Drug: Paclitaxel

Interventions

CTX-009 (ABL001) DRUG

CTX-009 (ABL001) will be administered biweekly.

CTX-009 (ABL001) and Irinotecan (P1b); CTX-009 (ABL001) and Paclitaxel (P1b); CTX-009 (ABL001) and Paclitaxel (P2)

Paclitaxel DRUG

Paclitaxel will be administered weekly.

CTX-009 (ABL001) and Paclitaxel (P1b); CTX-009 (ABL001) and Paclitaxel (P2)

Irinotecan DRUG

Irinotecan will be administered biweekly.

CTX-009 (ABL001) and Irinotecan (P1b)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Handok Inc.: lead
• Compass Therapeutics: collaborator
• ABL Bio, Inc.: collaborator

Study Sites (4)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

asciminib; Paclitaxel; Irinotecan

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 30, 2020
• Study Start: June 22, 2020
• Primary Completion: January 8, 2024
• Study Completion: January 9, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

KR (4)