Who is sponsoring NCT05533463?

NCT05533463 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT05533463?

Interventions in NCT05533463: HRS-4642.

What condition does NCT05533463 study?

NCT05533463 studies Advanced KRAS G12D Mutant Solid Tumors.

Is NCT05533463 still recruiting?

NCT05533463 is currently active, enrolled. Last updated 8 September 2025.

Last reviewed 2025-09-08 · How we verify

NCT05533463

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

Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Active, enrolled Phase 1 Last updated 8 September 2025

What this trial tests

Phase 1 trial testing HRS-4642 in Advanced KRAS G12D Mutant Solid Tumors in 102 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 September 2022

Primary endpoint
25 June 2024

30 December 2025

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	21 September 2022
Primary completion	25 June 2024
Estimated completion	30 December 2025
Sites	1 location across China

Drugs / interventions tested

HRS-4642 — full drug profile →

Conditions studied

Advanced KRAS G12D Mutant Solid Tumors — all drugs for Advanced KRAS G12D Mutant Solid Tumors →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Advanced KRAS G12D Mutant Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is being conducted to evaluate the safety and tolerability of HRS-4642 in patients with advanced solid tumors harboring KRAS G12D mutation.To estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose \[RP2D\]) within investigated subject population groups

Publications & conference data

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

Targeting KRAS in cancer.
Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0
A Small Molecule with Big Impact: MRTX1133 Targets the KRASG12D Mutation in Pancreatic Cancer.
Wei D, Wang L, Zuo X, Maitra A, et al · · 2024 · cited 102× · PMID 37831007 · DOI 10.1158/1078-0432.ccr-23-2098
Consensus, debate, and prospective on pancreatic cancer treatments.
Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x
RAS signaling in carcinogenesis, cancer therapy and resistance mechanisms.
Yang X, Wu H. · · 2024 · cited 53× · PMID 39522047 · DOI 10.1186/s13045-024-01631-9
Targeting KRAS in pancreatic cancer.
Stickler S, Rath B, Hamilton G. · · 2024 · cited 44× · PMID 38686056 · DOI 10.32604/or.2024.045356
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
KRAS G12C inhibitor combination therapies: current evidence and challenge.
Miyashita H, Kato S, Hong DS. · · 2024 · cited 39× · PMID 38756650 · DOI 10.3389/fonc.2024.1380584
RAS degraders: The new frontier for RAS-driven cancers.
Escher TE, Satchell KJF. · · 2023 · cited 32× · PMID 36945775 · DOI 10.1016/j.ymthe.2023.03.017

Verify or expand the search:

Other trials of HRS-4642

Trials testing the same drug.

NCT06938282 — An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer · Phase 2 · not yet recruiting
NCT06770452 — HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients · Phase 2 · recruiting

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · 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 NCT05533463 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Jiangsu HengRui Medicine Co., Ltd.
Last refreshed: 8 September 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/NCT05533463.

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