JAB-21822 / Solid Tumor / Nsclc · Phase 1/2 Trial

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

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1/2 clinical trial registration for JAB-21822 (glecirasib), a KRAS p.G12C inhibitor, in patients with advanced solid tumors including NSCLC. The study is actively enrolling to determine the recommended Phase 2 dose and assess safety, tolerability, and preliminary efficacy, but no results have yet been posted to the registry.

What was studied

Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. NSCLC, Solid Tumor; age from 18 Years. Intervention: Phase 1 Dose Exploration; Phase IIa Dose Expansion; Phase IIb. n = 315. 1 site: China.

Key findings

Safety

Primary outcomes focus on safety and dose-finding rather than clinical efficacy endpoints. No baseline characteristics, enrollment progress, or interim safety data are reported.

Who this may help

This trial is in early stages and cannot yet guide clinical practice. Results when available will first establish dose-limiting toxicity profile and recommended Phase 2 dose before efficacy can be assessed.

Plain-language summary

Phase 1/2 trial in early stage of recruitment with no results yet posted; primary outcomes are safety and dose-finding rather than efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Incidence of dose limiting toxicities (DLTs) in the dose escalation phase (assessed at first 21 days); Number of participants with adverse events (assessed at up to 3 years); Overall response rate (ORR) by IRC (independent review committee) (assessed at up to 3 years)

DesignPhase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose

PopulationNSCLC, Solid Tumor; age from 18 Years

Sample size315

InterventionPhase 1 Dose Exploration; Phase IIa Dose Expansion; Phase IIb

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment315

Study phasePhase 1/2

Primary outcome: Incidence of dose limiting toxicitiesfirst 21 days of dose escalation phase

Primary outcome: Adverse events assessmentup to 3 years

Primary outcome: Overall response rate by IRCup to 3 years

Clinical bottom line

Caveats

No results have been posted to this registry record; this is a study registration only.
Primary outcomes focus on safety and dose-finding rather than clinical efficacy endpoints.
Blinding status, control arm design, and detailed eligibility criteria are not specified in this registry entry.
No baseline characteristics, enrollment progress, or interim safety data are reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional Phase 1/2 design appropriate for dose escalation and preliminary efficacy assessment.

Directness

moderate

Directly addresses KRAS p.G12C-mutant advanced solid tumors in intended population.

Consistency

insufficient

No results posted; cannot assess consistency with other data.

Risk of bias

insufficient

Registry record lacks methodology detail; blinding and comparator not specified.

Sample adequacy

moderate

Planned enrollment of 315 participants adequate for Phase 1/2 dose escalation and preliminary efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05009329). This is a study registration, not published results. Lead sponsor: Allist Pharmaceuticals, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 315 participants (ACTUAL). Conditions: NSCLC, Solid Tumor. Interventions: DRUG: JAB-21822; DRUG: JAB-21822; DRUG: JAB-21822. Primary outcome measures: Incidence of dose limiting toxicities (DLTs) in the dose escalation phase , first 21 days; Number of participants with adverse events , up to 3 years; Overall response rate (ORR) by IRC (independent review committee) , up to 3 years. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05009329JAB-21822Allist PharmaceuticalsSolid TumorNsclc