NCT05288205 is a Phase 1/Phase 2 clinical trial of JAB-21822 in KRAS P.G12C, sponsored by Allist Pharmaceuticals, Inc..

Who is sponsoring NCT05288205?

NCT05288205 is sponsored by Allist Pharmaceuticals, Inc..

What drugs are being tested in NCT05288205?

Interventions in NCT05288205: JAB-21822, JAB-3312.

What condition does NCT05288205 study?

NCT05288205 studies KRAS P.G12C, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma.

Is NCT05288205 still recruiting?

NCT05288205 is currently recruiting now. Last updated 3 April 2025.

Last reviewed 2025-04-03 · How we verify

NCT05288205

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

Recruiting now Phase 1/Phase 2 Last updated 3 April 2025

What this trial tests

Phase 1/Phase 2 trial testing JAB-21822 in KRAS P.G12C in 240 participants. Currently enrolling.

Timeline

14 April 2022

Primary endpoint
1 March 2026

1 March 2026

Quick facts

Lead sponsor	Allist Pharmaceuticals, Inc.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	14 April 2022
Primary completion	1 March 2026
Estimated completion	1 March 2026
Sites	27 locations across China

Drugs / interventions tested

JAB-21822 — full drug profile →
JAB-3312 — full drug profile →

Conditions studied

KRAS P.G12C — all drugs for KRAS P.G12C →
Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
Colorectal Cancer — all drugs for Colorectal Cancer →
Pancreatic Ductal Carcinoma — all drugs for Pancreatic Ductal Carcinoma →

Sponsor

Allist Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with KRAS P.G12C or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

recommended phase-2 dose (RP2D).
Time frame: Approximately 2 years
RP2D should be selected based on a comprehensive assessment of maximum tolerated dose(MTD), toxicity, pharmacokinetic(PK) profile, and efficacy data.
Number of participants with dose limiting toxicities
Time frame: Approximately 2 years
Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically significant abnormal laboratory value occurring in Cycle 1 (DLT assessment period), which is unrelated to progressive disease, concurrent disease, or concomitant medication but related to JAB-21822 and/or JAB-3312, and meets the criteria for DLT.

Sponsor's own description

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The current state of the art and future trends in RAS-targeted cancer therapies.
Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
Targeting KRAS in cancer.
Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0
SHP2: A Pleiotropic Target at the Interface of Cancer and Its Microenvironment.
Sodir NM, Pathria G, Adamkewicz JI, Kelley EH, et al · · 2023 · cited 69× · PMID 37682219 · DOI 10.1158/2159-8290.cd-23-0383
KRAS in NSCLC: State of the Art and Future Perspectives.
Cascetta P, Marinello A, Lazzari C, Gregorc V, et al · · 2022 · cited 56× · PMID 36358848 · DOI 10.3390/cancers14215430
Targeting small GTPases: emerging grasps on previously untamable targets, pioneered by KRAS.
Yin G, Huang J, Petela J, Jiang H, et al · · 2023 · cited 50× · PMID 37221195 · DOI 10.1038/s41392-023-01441-4
KRAS Mutations in Solid Tumors: Characteristics, Current Therapeutic Strategy, and Potential Treatment Exploration.
Yang Y, Zhang H, Huang S, Chu Q. · · 2023 · cited 50× · PMID 36675641 · DOI 10.3390/jcm12020709
MYC and KRAS cooperation: from historical challenges to therapeutic opportunities in cancer.
Casacuberta-Serra S, González-Larreategui Í, Capitán-Leo D, Soucek L. · · 2024 · cited 43× · PMID 39164274 · DOI 10.1038/s41392-024-01907-z

Verify or expand the search:

Other trials of JAB-21822

Trials testing the same drug.

NCT06416410 — JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06162169 — A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects · Phase 1 · completed
NCT06008288 — A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harbor · Phase 2 · recruiting
NCT05875493 — A Food Effect Study of JAB-21822 in Healthy Subjects · Phase 1 · completed

Other recruiting trials for KRAS P.G12C

Currently open trials in the same condition.

NCT06008288 — A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harbor · Phase 2 · recruiting
NCT05631249 — Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C · Phase 2 · recruiting
NCT05398094 — Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy · Phase 2 · recruiting

Other Allist Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT07010419 — A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With St · Phase 3 · recruiting
NCT06416410 — JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06162169 — A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects · Phase 1 · completed
NCT06008288 — A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harbor · Phase 2 · recruiting
NCT05920941 — Mass Balance Study of [14C]JAB-21822 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05288205 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allist Pharmaceuticals, Inc.
Last refreshed: 3 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05288205.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing