P1b: Advanced Solid Tumors, P2: Biliary Tract Cancer
Conditions
Keywords
VEGF, DLL4, Solid Tumors, Bispecific antibody, anti-angiogenic
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).
Interventions
DRUGCTX-009 (ABL001)
CTX-009 (ABL001) will be administered biweekly.
DRUGPaclitaxel
Paclitaxel will be administered weekly.
DRUGIrinotecan
Irinotecan will be administered biweekly.
Sponsors
Compass Therapeutics
ABL Bio, Inc.
Handok Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| P2: Overall survival (OS) | Up to approximately 24 months | Time from the initiation of treatment to death |
| 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 |
| 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) |
Countries
South Korea
Outcome results
None listed