KRAS G12C Mutant Advanced Solid TumorsPhase 1/2NCT06237400
A Study of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
A Phase 1/2 study testing ZG19018 in people with KRAS G12C Mutant Advanced Solid Tumors, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS G12C Mutant Advanced Solid Tumors
- What is being tested?
- ZG19018
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2022to May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who fully understood this trial and voluntarily signed the informed consent form;
- Men or women ≥ 18 years old;
- ECOG Performance Status (PS) 0 or 1;
- Life expectancy > 3 months.
Who cannot join
- Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.;
- Patients requiring medications that can potentially prolong QTc interval;
- Other conditions that the investigator considers to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jianming Xu, jmxu2003@163.com
About this study
Official title: A Phase I/II Dose Escalation and Expansion Study to Evaluating the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.
- Conditions
- KRAS G12C Mutant Advanced Solid Tumors
- Being tested
- ZG19018
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG19018Drug
ZG19018 Given by PO (mouth)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: ZG19018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start26 May 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS G12C Mutant Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237400
- Sponsor's protocol ID
- ZG19018-001
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose Escalation and Expansion Study to Evaluating the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06237400
- Acronym / sponsor ID
- ZG19018-001
- Conditions
- KRAS G12C Mutant Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 26 May 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Drug: ZG19018Dose 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. |
| Phase 2 Dose Expansion | Experimental | Drug: ZG19018Upon 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who fully understood this trial and voluntarily signed the informed consent form;
- Men or women ≥ 18 years old;
- ECOG Performance Status (PS) 0 or 1;
- Life expectancy > 3 months.
Key exclusion criteria (3 listed)
- Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.;
- Patients requiring medications that can potentially prolong QTc interval;
- Other conditions that the investigator considers to be unsuitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZG19018ZG19018 Given by PO (mouth) | Drug | Phase 1 Dose Escalation, Phase 2 Dose Expansion |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: Up to 21Days
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.
Objective Response Rate (ORR)
Time frame: Up to 24 Months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for KRAS G12C Mutant Advanced Solid Tumors
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Neoplasm Malignant
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JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
Advanced Solid Tumors
Active, not recruitingPhase 2
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZG19018 in people with KRAS G12C Mutant Advanced Solid Tumors, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Wei (+86-0512-57309965, weic@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: Up to 21Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.