A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China

Solid Tumor Clinical Trial

Official title:

Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05009329
• Other study ID #: JAB-21822-1002
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 26, 2021
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 311
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent

2. Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment

3. Subject must be =18 years

4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

5. Subjects with life expectancy =3 months.

6. Subjects must have at least one measurable lesion as defined by RECIST v1.1.

7. There was no serious organ dysfunction in the screening stage

8. Male or female subjects of reproductive age agree to use adequate contraception

Exclusion Criteria:

1. History of intestinal disease or major gastric surgery or inability to swallow oral medications

2. Other active cancer

3. Previously treated with KRAS G12C inhibitor

4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)

5. Impaired heart function or clinically significant heart disease

6. Pregnant or breast-feeding

7. Previous allogeneic bone marrow transplant or organ transplant

8. Intended study subjects who were unable to abstain from alcohol during medication

9. Other unqualified conditions judged by the investigators

Related Conditions & MeSH terms

• Neoplasms
• NSCLC
• Solid Tumor

Intervention

Drug:
• JAB-21822
JAB-21822 will be administered orally
• JAB-21822
JAB-21822 will be administered orally
• JAB-21822
JAB-21822 will be administered orally

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities (DLTs) in the dose escalation phase	Number of participants with dose limiting toxicities	first 21 days
Primary	Number of participants with adverse events	Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria	up to 3 years
Primary	Overall response rate (ORR) by IRC (independent review committee)	ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1	up to 3 years
Secondary	Overall response rate (ORR) by investigator	ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1	up to 3 years
Secondary	Duration of response ( DOR )	DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.	up to 3 years
Secondary	Disease Control Rate ( DCR )	DCR is defined as percentage of participants with complete response (CR), partial response (PR), and stable disease(SD) per RECIST v1.1	up to 3 years
Secondary	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 or death per RECIST v1.1, which occurs first	up to 3 years
Secondary	Time to response (TTR)	Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria	up to 3 years
Secondary	Peak Plasma Concentration (Cmax)	Cmax of JAB-21822 will be measured by using plasma PK samples	up to 3 years