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

Allist Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Solid Tumor; NSCLC

Treatments: Drug: JAB-21822

Study type: Interventional

Funder types: Industry

Identifiers

NCT05009329

JAB-21822-1002

Details and patient eligibility

About

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.

Enrollment: 311 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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311 participants in 3 patient groups

Phase 1 Dose Exploration

Experimental group

Description:

Dose escalation of JAB-21822 to determine maximum tolerated dose.

Treatment:

Drug: JAB-21822

Drug: JAB-21822

Drug: JAB-21822

Phase IIa Dose Expansion

Experimental group

Description:

Patients with KRAS p.G12C mutant advanced non small cell lung cancer or other solid tumors will be enrolled and treated at the monotherapy RP2D to evaluate the safety and preliminary efficacy.

Treatment:

Drug: JAB-21822

Drug: JAB-21822

Drug: JAB-21822

Phase IIb

Experimental group

Description:

Patients with KRAS p.G12C mutant advanced non small cell lung cancer will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.

Treatment:

Drug: JAB-21822

Drug: JAB-21822

Drug: JAB-21822