Active — Not RecruitingPhase 1/2

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

China315 participantsStarted 2021-07-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent
✓. Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment
✓. Subject must be ≥18 years
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
✓. Subjects with life expectancy ≥3 months.
✓. Subjects must have at least one measurable lesion as defined by RECIST v1.1.
✓. There was no serious organ dysfunction in the screening stage
✓. Male or female subjects of reproductive age agree to use adequate contraception

Exclusion criteria

✕. History of intestinal disease or major gastric surgery or inability to swallow oral medications
✕. Other active cancer
✕. Previously treated with KRAS G12C inhibitor
✕. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
✕. Impaired heart function or clinically significant heart disease
✕. Pregnant or breast-feeding

What they're measuring

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase

Timeframe: first 21 days

Number of participants with adverse events

Timeframe: up to 3 years

Overall response rate (ORR) by IRC (independent review committee)

Timeframe: up to 3 years

Trial details

NCT IDNCT05009329

SponsorAllist Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

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