NCT04492033

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• P1b: Advanced Solid Tumors
• P2: Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	CTX-009 (ABL001)	CTX-009 (ABL001) will be administered biweekly.
DRUG	Paclitaxel	Paclitaxel will be administered weekly.
DRUG	Irinotecan	Irinotecan will be administered biweekly.

Timeline

• Start date: 2020-06-22
• Primary completion: 2024-01-08
• Completion: 2025-01-09
• First posted: 2020-07-30
• Last updated: 2025-01-27

Locations

4 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study