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

Handok

Status and phase: Terminated; Phase 2; Phase 1

Conditions: P1b: Advanced Solid Tumors; P2: Biliary Tract Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04492033

ABL001-P1bC

CTX-009-001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 41 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

CTX-009 (ABL001) and Paclitaxel (P1b)

Experimental group

Treatment:

Drug: Paclitaxel

Drug: CTX-009 (ABL001)

CTX-009 (ABL001) and Irinotecan (P1b)

Experimental group

Description:

1 cycle = 4weeks

Treatment:

Drug: Irinotecan

Drug: CTX-009 (ABL001)

CTX-009 (ABL001) and Paclitaxel (P2)

Experimental group

Description:

1 cycle = 4weeks

Treatment:

Drug: Paclitaxel

Drug: CTX-009 (ABL001)