NCT06237413 is a Phase 1/Phase 2 clinical trial of ZG2001 Tosilate Tablets in Solid Tumor, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd.

Who is sponsoring NCT06237413?

NCT06237413 is sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd.

What drugs are being tested in NCT06237413?

Interventions in NCT06237413: ZG2001 Tosilate Tablets.

What condition does NCT06237413 study?

NCT06237413 studies Solid Tumor, KRAS Mutation-Related Tumors.

Is NCT06237413 still recruiting?

NCT06237413 is currently status unknown. Last updated 4 March 2024.

Last reviewed 2024-03-04 · How we verify

NCT06237413

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

A Phase I/II Dose Escalation Study to Evaluating the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Tosilate Tablets in Participants With KRAS Mutated Advanced Solid Tumours

Status unknown Phase 1/Phase 2 Last updated 4 March 2024

What this trial tests

Phase 1/Phase 2 trial testing ZG2001 Tosilate Tablets in Solid Tumor in 110 participants. Status unknown.

Timeline

10 August 2023

Primary endpoint
1 February 2026

1 February 2026

Quick facts

Lead sponsor	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	10 August 2023
Primary completion	1 February 2026
Estimated completion	1 February 2026
Sites	1 location across China

Drugs / interventions tested

ZG2001 Tosilate Tablets — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →
KRAS Mutation-Related Tumors — all drugs for KRAS Mutation-Related Tumors →

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or KRAS Mutation-Related Tumors. 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.

Dose Limiting Toxicity (DLT)
Time frame: Up to 21 Days
A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the 1st treatment cycle of ZG2001 (Day 1 through Day 21) where the relationship to ZG2001 cannot be ruled out.
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 24 Months
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

Sponsor's own description

This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.

Publications & conference data

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

KRAS mutated NSCLC: past, present, and future directions in a rapidly evolving landscape.
Frisch A, Martin E, Kim SY, Riess JW, et al · · 2025 · cited 4× · PMID 40586765 · DOI 10.1093/oncolo/oyaf153
Precision immune regulation in KRAS-mutated cancers: the final piece of the puzzle?
Fu S, Ma J, Cai C, Tan J, et al · · 2025 · cited 3× · PMID 40611261 · DOI 10.1186/s13046-025-03444-1

Verify or expand the search:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials

Trials by the same sponsor.

NCT05279001 — A Safety and Tolerability Study of Jaktinib · Phase 1 · unknown
NCT06193148 — A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants · Phase 1 · completed
NCT06132243 — Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions · Phase 1 · completed
NCT05864573 — Study of ZGGS15 in Patients With Advanced Solid Tumors · Phase 1 · completed
NCT05584800 — Study of ZGGS18 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

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 NCT06237413 (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 Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Last refreshed: 4 March 2024

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/NCT06237413.

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