A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours

NCT06237413 | Recruiting Phase 1

• 1 other identifier: ZG2001-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor; KRAS Mutation-Related Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  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.

  Up to 21 Days

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

  Up to 24 Months

Study Arms (2)

Phase 1 Dose Escalation

EXPERIMENTAL

This Phase adopts an open-label design, with an Accelerated Titration(AT) design for the low-dose group (50 mg Bid) and the standard "3+3" design for the high-dose groups（100 mg Bid、50 mg Qd、100 mg Qd、200 mg Qd）.

Drug: ZG2001 Tosilate Tablets

Phase 2 Dose Expansion

EXPERIMENTAL

After the completion of the dose escalation study, RP2D will be selected for dose expansion in advanced solid tumors (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) with KRAS mutations that have failed at least the first-line standard treatment

Drug: ZG2001 Tosilate Tablets

Interventions

ZG2001 Tosilate Tablets DRUG

ZG2001 will be administered orally once or twice daily in a continuous regimen

Also known as: ZG2001

Phase 1 Dose Escalation; Phase 2 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who fully understood this study and voluntarily signed the informed consent form;
• Men or women ≥ 18 years old;
• Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit.
• ECOG Performance Status (PS) 0 or 1;
• Life expectancy \> 3 months.

You may not qualify if:

• Received any SOS1 inhibitors;
• Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study;
• Other conditions that the investigator considers to be unsuitable for participation in this study.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Cheng Wei

CONTACT

+86-0512-57309965; weic@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: August 10, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)