QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05799820
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Carcinoma	Drug: QL1706; Drug: Bevacizumab; Drug: Oxaliplatin injection; Drug: Capecitabine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
• Actual Study Start Date: Sep 29, 2022
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QL1706	Drug: QL1706; 5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Experimental: QL1706 in combination with bevacizumab and XELOX	Drug: QL1706; 5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle; Drug: Bevacizumab; 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle; Drug: Oxaliplatin injection; 130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle; Drug: Capecitabine; 1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (ORR) [Up to approximately 2 years]

   ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Secondary Outcome Measures

1. Disease Control Rate (DCR) [Up to approximately 2 years]

   DCR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

2. Duration of Response (DOR) [Up to approximately 2 years]

   DOR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

3. Progression-free Survival (PFS) [Up to approximately 2 years]

   PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

4. Overall Survival (OS) [Up to approximately 2 years]

   OS was defined as the time from randomization to death due to any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Subjects participate voluntarily and sign informed consent.
• 1. Age ≥ 18 and ≤ 80 years old, male or female.
• 1. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
• 1. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

Exclusion Criteria:

• 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
• 1. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
• 1. Has active autoimmune disease that has required systemic treatment in past 2 years.
• 1. Significant cardiovascular disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai East Hospital	Shanghai	Shanghai	China	200120

Sponsors and Collaborators

• Qilu Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Jin Li, MD, Shanghai East Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qilu Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05799820
• Other Study ID Numbers: QL1706-208
• First Posted: Apr 5, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms; Bevacizumab; Capecitabine; Oxaliplatin

Study Results

No Results Posted as of Apr 5, 2023