A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382442
• Other study ID #: AK112-206
• Status: Recruiting
• Phase: Phase 2
• Start date: July 27, 2022
• Est. completion date: December 25, 2026

Study information

• Verified date: February 2024
• Source: Akeso
• Contact: Xufang Yu, MD
• Phone: +86(0760)89873999
• Email: clincialtrails[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 25, 2026
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically proven diagnosis of colorectal adenocarcinoma

• Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be =12 months after the last administration of neoadjuvant or adjuvant therapy

• Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Measurable disease as defined by RECIST v1.1

• Adequate hematologic and organ function

Exclusion Criteria:

• Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)

• Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway

• History of autoimmune disease

• Prior allogeneic stem cell or solid organ transplantation

• Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C

• Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment

• Pregnancy or lactation

• Dysphagia

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• AK112
AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
• AK117
AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
• Oxaliplatin
Oxaliplatin via IV infusion
• Capecitabine
Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
• Irinotecan
Irinotecan via IV infusion
• Leucovorin
Leucovorin via IV infusion
• 5-fluorouracil
5-fluorouracil via IV infusion

Locations

Country	Name	City	State
China	The Sixth Hospital,Sun Yat-sen University	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rates (ORR)	ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1	Up to approximately 2 years
Primary	Number of participants with adverse events (AEs)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	Up to approximately 2 years
Secondary	Disease control rate (DCR)	Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1	Up to approximately 2 years
Secondary	Duration of response (DOR)	DOR is defined for participants who had an objective response as the time from the first occurrence of a documented confirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause,whichever occurred first	Up to approximately 2 years
Secondary	Time to response (TTR)	TTR is defined for participants who had an objective response as the time from the start of treatment to the first occurrence of a documented unconfirmed response (CR or PR) .	Up to approximately 2 years
Secondary	Progression-free survival (PFS)	PFS is defined as the time from the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).	Up to approximately 2 years
Secondary	Progression-free survival 2 (PFS2)	PFS 2 is defined as the time from the start of treatment till the second documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).	Up to approximately 2 years
Secondary	Overall survival (OS)	Overall survival is defined as the time from the start of treatment until death due to any cause.	Up to approximately 2 years