P1b: Advanced Solid TumorsPhase 1/2NCT04492033
A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
A Phase 1/2 study testing CTX-009 (ABL001), Paclitaxel and Irinotecan in people with P1b: Advanced Solid Tumors and P2: Biliary Tract Cancer, run by Handok Inc. at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- P1b: Advanced Solid Tumors, P2: Biliary Tract Cancer
- What is being tested?
- CTX-009 (ABL001), Paclitaxel and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 22 Jun 2020to 9 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
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
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.
Read the 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).
- Being tested
- CTX-009 (ABL001), Paclitaxel, Irinotecan
- Keywords
- VEGF, DLL4, Solid Tumors, Bispecific antibody, anti-angiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-009 (ABL001)Drug
CTX-009 (ABL001) will be administered biweekly.
PaclitaxelDrug
Paclitaxel will be administered weekly.
IrinotecanDrug
Irinotecan will be administered biweekly.
| Study group | Role | What they receive |
|---|---|---|
| CTX-009 (ABL001) and Paclitaxel (P1b) | Experimental | Not described Receives: Drug: CTX-009 (ABL001); Drug: Paclitaxel |
| CTX-009 (ABL001) and Irinotecan (P1b) | Experimental | 1 cycle = 4weeks Receives: Drug: CTX-009 (ABL001); Drug: Irinotecan |
| CTX-009 (ABL001) and Paclitaxel (P2) | Experimental | 1 cycle = 4weeks Receives: Drug: CTX-009 (ABL001); Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to approximately 24 months
Secondary outcomes (9)
Adverse Events (AEs)
Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to approximately 24 months
Pharmacokinetics (PK) of CTX-009 (ABL001)
Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)
Measured: Up to approximately 24 months
Objective response rate (ORR)
Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review
Measured: Up to approximately 24 months
Disease control rate (DCR)
Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)
Measured: Up to approximately 24 months
Time to treatment failure (TTF)
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
Measured: Up to approximately 24 months
Duration of response (DOR)
Time interval from first occurrence of a documented objective response to the time of disease progression
Measured: Up to approximately 24 months
Progression-free survival (PFS)
The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death
Measured: Up to approximately 24 months
P2: Survival rate
The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment
Measured: 6 months and 12 months
P2: Overall survival (OS)
Time from the initiation of treatment to death
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start22 Jun 2020
- Primary completion8 Jan 2024
- Study completion9 Jan 2025
Why it stopped: Change of Development Plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for P1b: Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Compass Therapeutics, ABL Bio, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492033
- Sponsor's protocol ID
- ABL001-P1bC
- Other IDs
- CTX-009-001
- Status last verified
- Jan 2025
- First submitted
- 15 Jun 2020
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04492033
- Acronym / sponsor ID
- ABL001-P1bC
- Keywords
- VEGF, DLL4, Solid Tumors, Bispecific antibody, anti-angiogenic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of Development Plan
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Collaborators
- Compass Therapeutics, ABL Bio, Inc.
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTX-009 (ABL001) and Paclitaxel (P1b) | Experimental | Drug: CTX-009 (ABL001), Drug: Paclitaxel |
| CTX-009 (ABL001) and Irinotecan (P1b) | Experimental | Drug: CTX-009 (ABL001), Drug: Irinotecan1 cycle = 4weeks |
| CTX-009 (ABL001) and Paclitaxel (P2) | Experimental | Drug: CTX-009 (ABL001), Drug: Paclitaxel1 cycle = 4weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX-009 (ABL001)CTX-009 (ABL001) will be administered biweekly. | Drug | CTX-009 (ABL001) and Irinotecan (P1b), CTX-009 (ABL001) and Paclitaxel (P1b), CTX-009 (ABL001) and Paclitaxel (P2) |
| PaclitaxelPaclitaxel will be administered weekly. | Drug | CTX-009 (ABL001) and Paclitaxel (P1b), CTX-009 (ABL001) and Paclitaxel (P2) |
| IrinotecanIrinotecan will be administered biweekly. | Drug | CTX-009 (ABL001) and Irinotecan (P1b) |
Primary outcome
P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)
Time frame: 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
Time frame: 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
9 secondary outcomes
Adverse Events (AEs)
Time frame: Up to approximately 24 months
Pharmacokinetics (PK) of CTX-009 (ABL001)
Time frame: Up to approximately 24 months
Objective response rate (ORR)
Time frame: Up to approximately 24 months
Disease control rate (DCR)
Time frame: Up to approximately 24 months
Time to treatment failure (TTF)
Time frame: Up to approximately 24 months
Duration of response (DOR)
Time frame: Up to approximately 24 months
Progression-free survival (PFS)
Time frame: Up to approximately 24 months
P2: Survival rate
Time frame: 6 months and 12 months
P2: Overall survival (OS)
Time frame: Up to approximately 24 months
Results and safety
The study was stopped early (reason given: Change of Development Plan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CTX-009 (ABL001), Paclitaxel and Irinotecan in people with P1b: Advanced Solid Tumors and P2: Biliary Tract Cancer, run by Handok Inc. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change of Development Plan). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT) (time frame: From Day 1 until disease progression or Day 28, whichever came first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.