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JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

Primary Purpose

Advanced Colorectal Cancer, Small Intestinal Cancer, Appendiceal Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JAB-21822
Cetuximab
Sponsored by
Jacobio Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must be able to provide an archived tumor sample
  • Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation
  • Must have received at least 1 prior standard therapy
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Must have adequate organ function
  • Must be able to swallow and retain orally administered medication

Exclusion Criteria:

  • Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  • Active infection requiring systemic treatment within 14 days
  • Active HIV, HBV or HCV
  • Any severe and/or uncontrolled medical conditions
  • LVEF<50% assessed by ECHO
  • QT interval >470 msec

Sites / Locations

  • Research site31
  • Research site01Recruiting
  • Research site02
  • Research site12Recruiting
  • Research site20
  • Research site26
  • Research site03
  • Research site13
  • Research site06Recruiting
  • Research site05
  • Research site07Recruiting
  • Research site18Recruiting
  • Research site11Recruiting
  • Research site29
  • Research site09Recruiting
  • Research site24
  • Research site32
  • Research site08Recruiting
  • Research site04
  • Research site10
  • Research site14
  • Research site15
  • Research site16Recruiting
  • Research site28Recruiting
  • Research site22
  • Research site23
  • Research site17
  • Research site19
  • Research site21

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1b Dose Escalation

Phase 2 Dose Expansion, Cohort 1

Phase 2 Dose Expansion, Cohort 2

Arm Description

Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.

Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.

Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.

Outcomes

Primary Outcome Measures

Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs)
A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.
Dose Expansion phase: Overall response rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.

Secondary Outcome Measures

Dose Escalation and Dose Expansion phase: Number of participants with adverse events
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria.
Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)
Cmax of JAB-21822 will be measured by using plasma PK samples.
Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)
AUC of JAB-21822 will be measured by using plasma PK samples.
Dose Expansion phase: Duration of response ( DOR )
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Dose Escalation phase: Overall response rate (ORR)
The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
Dose Expansion phase: Disease Control Rate ( DCR )
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1.
Dose Expansion phase: Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first.

Full Information

First Posted
December 27, 2021
Last Updated
March 9, 2023
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05194995
Brief Title
JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation
Official Title
A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jacobio Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.
Detailed Description
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer, Small Intestinal Cancer, Appendiceal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1b Dose Escalation
Arm Type
Experimental
Arm Description
Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.
Arm Title
Phase 2 Dose Expansion, Cohort 1
Arm Type
Experimental
Arm Description
Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
Arm Title
Phase 2 Dose Expansion, Cohort 2
Arm Type
Experimental
Arm Description
Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.
Intervention Type
Drug
Intervention Name(s)
JAB-21822
Intervention Description
JAB-21822 administered orally as a tablet.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab administered as an intravenous (IV) infusion.
Primary Outcome Measure Information:
Title
Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs)
Description
A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.
Time Frame
At the end of Cycle 1 (each cycle is 21 days)
Title
Dose Expansion phase: Overall response rate (ORR)
Description
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.
Time Frame
Up to 4 years - from baseline to RECIST confirmed Progressive Disease
Secondary Outcome Measure Information:
Title
Dose Escalation and Dose Expansion phase: Number of participants with adverse events
Description
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria.
Time Frame
Up to 4 years
Title
Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)
Description
Cmax of JAB-21822 will be measured by using plasma PK samples.
Time Frame
Up to 4 years
Title
Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)
Description
AUC of JAB-21822 will be measured by using plasma PK samples.
Time Frame
Up to 4 years
Title
Dose Expansion phase: Duration of response ( DOR )
Description
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Time Frame
Up to 4 years
Title
Dose Escalation phase: Overall response rate (ORR)
Description
The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
Time Frame
Up to 4 years
Title
Dose Expansion phase: Disease Control Rate ( DCR )
Description
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1.
Time Frame
Up to 4 years
Title
Dose Expansion phase: Progression-free survival (PFS)
Description
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be able to provide an archived tumor sample Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation Must have received at least 1 prior standard therapy Must have at least 1 measurable lesion per RECIST v1.1 Must have adequate organ function Must be able to swallow and retain orally administered medication Exclusion Criteria: Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days Active infection requiring systemic treatment within 14 days Active HIV, HBV or HCV Any severe and/or uncontrolled medical conditions LVEF<50% assessed by ECHO QT interval >470 msec
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobio Pharmaceuticals
Phone
86-10-56315466
Email
clinicaltrials@jacobiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobio Pharmaceuticals
Organizational Affiliation
Jacobio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research site31
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site01
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Individual Site Status
Recruiting
Facility Name
Research site02
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site12
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Individual Site Status
Recruiting
Facility Name
Research site20
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site26
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528300
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site03
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site13
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site06
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Research site05
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site07
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Research site18
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Research site11
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Name
Research site29
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site09
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Name
Research site24
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site32
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site08
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Recruiting
Facility Name
Research site04
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Withdrawn
Facility Name
Research site10
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site14
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site15
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site16
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276002
Country
China
Individual Site Status
Recruiting
Facility Name
Research site28
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research site22
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site23
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site17
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research site19
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site21
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

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