A Study of ABL001 in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

Sponsor
Handok Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04492033
Collaborator
ABL Bio, Inc. (Industry)
92
Enrollment
4
Locations
3
Arms
43.3
Anticipated Duration (Months)
23
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of 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

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2a Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics of ABL001 in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors
Actual Study Start Date :
Jun 22, 2020
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: ABL001 and Paclitaxel (P1b)

Drug: ABL001
ABL001 will be administered biweekly.

Drug: Paclitaxel
Paclitaxel will be administered weekly.

Experimental: ABL001 and Irinotecan (P1b)

1 cycle = 4weeks

Drug: ABL001
ABL001 will be administered biweekly.

Drug: Irinotecan
Irinotecan will be administered biweekly.

Experimental: ABL001 and Paclitaxel (P2)

1 cycle = 4weeks

Drug: ABL001
ABL001 will be administered biweekly.

Drug: Paclitaxel
Paclitaxel will be administered weekly.

Outcome Measures

Primary Outcome Measures

  1. 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 ABL001 and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects

  2. P2: Objective response rate (ORR) of 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 Outcome Measures

  1. 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

  2. Pharmacokinetics (PK) of ABL001 [Up to approximately 24 months]

    Serum concentrations of ABL001 will be collected and analyzed to evaluate the PK of ABL001

  3. 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

  4. 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)

  5. Time to treatment failure (TTF) [Up to approximately 24 months]

    Time interval from 1st administration of ABL001 to the time of disease progression or discontinuation of ABL001 due to whatever reason, whichever comes first

  6. 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

  7. 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

  8. 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

  9. Overall survival (OS) [Up to approximately 24 months]

    Time from the initiation of treatment to death

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
  • P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors

  • P2 only: Patients histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancer (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.

  • Patients aged 19 years or older

  • Lesions measured by tumor markers or by CT/MRI must be evaluable based on 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 major surgery and 2 weeks have elapsed since a minor 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 severe traumatic systemic disorders

  • 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 screening

  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Seoul National University Bundang HospitalSeongnam-siKorea, Republic of
2Asan Medical CenterSeoulKorea, Republic of
3Samsung Medical CenterSeoulKorea, Republic of
4Seoul National University HospitalSeoulKorea, Republic of

Sponsors and Collaborators

  • Handok Inc.
  • ABL Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Handok Inc.
ClinicalTrials.gov Identifier:
NCT04492033
Other Study ID Numbers:
  • ABL001-P1bC
First Posted:
Jul 30, 2020
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Handok Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021