Clinical trial NCT04492033: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: P1b: Advanced Solid Tumors
P2: Biliary Tract Cancer
Keywords: VEGF
DLL4
Solid Tumors
Bispecific antibody
anti-angiogenic
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
Collaborators: name: Compass Therapeutics
name: ABL Bio, Inc.
First posted: 2020-07-30
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)
timeFrame: From Day 1 until disease progression or Day 28, whichever came first
measure: P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 24 months
measure: Pharmacokinetics (PK) of CTX-009 (ABL001)
timeFrame: Up to approximately 24 months
measure: Objective response rate (ORR)
timeFrame: Up to approximately 24 months
measure: Disease control rate (DCR)
timeFrame: Up to approximately 24 months
measure: Time to treatment failure (TTF)
timeFrame: Up to approximately 24 months
measure: Duration of response (DOR)
timeFrame: Up to approximately 24 months
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 24 months
measure: P2: Survival rate
timeFrame: 6 months and 12 months
measure: P2: Overall survival (OS)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: