Solid TumorPhase 1/2NCT06237413
A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours
A Phase 1/2 study testing ZG2001 Tosilate Tablets in people with Solid Tumor and KRAS Mutation-Related Tumors, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, KRAS Mutation-Related Tumors
- What is being tested?
- ZG2001 Tosilate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to Feb 2026
- 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
- 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.
Who cannot join
- 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.
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 Study to Evaluating the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Tosilate Tablets in Participants With KRAS Mutated Advanced Solid Tumours
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
- Being tested
- ZG2001 Tosilate Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG2001 Tosilate TabletsDrug
Also called ZG2001
ZG2001 will be administered orally once or twice daily in a continuous regimen
| Study group | Role | What they receive |
|---|---|---|
| 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）. Receives: 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 Receives: Drug: ZG2001 Tosilate Tablets |
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 1st treatment cycle of ZG2001 (Day 1 through Day 21) where the relationship to ZG2001 cannot be ruled out.
Measured: Up to 21 Days
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
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 start10 Aug 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- NCT06237413
- Sponsor's protocol ID
- ZG2001-001
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2024
- Last updated
- 6 Mar 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06237413
- Acronym / sponsor ID
- ZG2001-001
- Conditions
- Solid Tumor, KRAS Mutation-Related 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
- 10 Aug 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (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.
This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.
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: ZG2001 Tosilate TabletsThis 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）. |
| Phase 2 Dose Expansion | Experimental | Drug: ZG2001 Tosilate TabletsAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| ZG2001 Tosilate TabletsAlso: ZG2001ZG2001 will be administered orally once or twice daily in a continuous regimen | Drug | Phase 1 Dose Escalation, Phase 2 Dose Expansion |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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 ZG2001 Tosilate Tablets in people with Solid Tumor and KRAS Mutation-Related 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 5 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 6 Mar 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 21 Days). 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 6 Mar 2024.