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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05009329
Other study ID # JAB-21822-1002
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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