Trials Sponsors Conditions Drugs Pricing

Conditions

KRAS G12C Mutant Advanced Solid 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 first treatment cycle of ZG19018 (day 1 through day 21) where elationship to ZG19018 cannot be ruled out.
Up to 21Days
Objective Response Rate (ORR)
The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.
Up to 24 Months

Study Arms (2)

Phase 1 Dose Escalation

EXPERIMENTAL

Dose escalation will begin with rapid dose escalation for the low-dose groups (50 mg QD 、150 mg QD) and a "3 + 3" dose-escalation protocol for the high-dose groups.

Drug: ZG19018

Phase 2 Dose Expansion

EXPERIMENTAL

Upon completing the dose escalation part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS G12C mutant advanced solid tumors，Including non-small cell lung cancer, colorectal cancer and Other advanced solid tumors

Drug: ZG19018

Interventions

ZG19018Drug

ZG19018 Given by PO (mouth)

Phase 1 Dose EscalationPhase 2 Dose Expansion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects who fully understood this trial and voluntarily signed the informed consent form;
Men or women ≥ 18 years old;

Sponsors & Collaborators

Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Industrylead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Jianming XuCONTACTjmxu2003@163.com

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 2
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

May 26, 2022

Actual (reported)

Primary Completion

May 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

A Study of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Phase 1 Dose Escalation

Phase 2 Dose Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Phase 1 Dose Escalation

Phase 2 Dose Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations