Non-small Cell Lung CancerPhase 1NCT06403735
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
A Phase 1 study testing QLC1101 in people with Non-small Cell Lung Cancer and Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- QLC1101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesChina
- Study dates
- 25 Apr 2024to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
- Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
- Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
- Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria.
- ECOG PS score: 0 or 1;
- Expected survival time ≥ 3 months;
- Adequate organ function at screening:
Who cannot join
- Previously treated with inhibitors against KRAS G12D mutation;
- The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives
- Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
- Presence of other active malignant tumors in addition to primary tumors;
- Presence of serious lung diseases at screening;
- Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption;
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- Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders;
- Complicated with clinically significant cardiovascular and cerebrovascular disorders;
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
- Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements;
- the investigator determines that participation in the study is not in the best interest of the subject.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510699
Xicheng Wang, Professor, 13902400598, 13902400598@126.com
- Not yet recruiting
Harbin Medical university cancer hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, Professor, 13845120210, yanqiaozhanggcp@163.com
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Runxiang Yang, Professor, 13888876721, 13888876721@163.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Shanxian Guo, Professor, 15270019607, guoshanxian0830@126.com
- Recruiting
Shanghai east hospital
Shanghai, Shanghai Municipality, 200000
Caicun Zhou, professor, 13301825532, caicunzhoudr@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLC1101 Monotherapy in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid tumors harboring a KRAS G12D mutation. The FIH study includes dose escalation, PK expansion, and efficacy expansion.
- Being tested
- QLC1101
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLC1101Drug
QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.QLC1101 can prevent GTP/GDP nucleotide exchange and/or the formation of KRAS G12D/GTP/RAF1 complex and inhibit mutant KRAS-dependent signal transduction by specifically binding to the KRAS G12D target, thereby inhibiting the generation of KRAS G12D mutant tumors.
| Study group | Role | What they receive |
|---|---|---|
| QLC1101 | Experimental | patients with advanced solid tumors harboring a KRAS G12D mutation were administrated with QLC1101 orally in a total of 6 dose groups at 100,200,400,600,900, and 1200 mg BID Receives: Drug: QLC1101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Subjects in this phase will be treated with single oral administration of QLC1101, observed for 4 days, and if tolerant, treated with repeated oral administration of QLC1101 twice daily for 21 consecutive days. After completing the DLT observation (the 25 days after the first dose as the DLT observation period), the subject will continue to receive repeated-dose treatment of Cycle 2 and subsequent cycles.
Measured: 25 days after the first dose
MTD (or MAD)
the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLC1101 monotherapy
Measured: 1 year
RP2D
the recommended phase II dose of QLC1101 monotherapy
Measured: 1.5 years
Secondary outcomes (2)
Preliminary efficacy endpoints
Objective response rate (ORR)
Measured: 3 years
Preliminary efficacy endpoints
overall survival (OS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start25 Apr 2024
- Primary completion31 May 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403735
- Sponsor's protocol ID
- QLC1101-101
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLC1101 Monotherapy in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT06403735
- Acronym / sponsor ID
- QLC1101-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 8 May 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.
QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid tumors harboring a KRAS G12D mutation. The FIH study includes dose escalation, PK expansion, and efficacy expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLC1101 | Experimental | Drug: QLC1101patients with advanced solid tumors harboring a KRAS G12D mutation were administrated with QLC1101 orally in a total of 6 dose groups at 100,200,400,600,900, and 1200 mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
- Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
- Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
- Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria.
- ECOG PS score: 0 or 1;
Key exclusion criteria (11 listed)
- Previously treated with inhibitors against KRAS G12D mutation;
- The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives
- Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
- Presence of other active malignant tumors in addition to primary tumors;
- Presence of serious lung diseases at screening;
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 |
|---|---|---|
| QLC1101QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.QLC1101 can prevent GTP/GDP nucleotide exchange and/or the formation of KRAS G12D/GTP/RAF1 complex and inhibit mutant KRAS-dependent signal transduction by specifically binding to the KRAS G12D target, thereby inhibiting the generation of KRAS G12D mutant tumors. | Drug | QLC1101 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 25 days after the first dose
Subjects in this phase will be treated with single oral administration of QLC1101, observed for 4 days, and if tolerant, treated with repeated oral administration of QLC1101 twice daily for 21 consecutive days. After completing the DLT observation (the 25 days after the first dose as the DLT observation period), the subject will continue to receive repeated-dose treatment of Cycle 2 and subsequent cycles.
MTD (or MAD)
Time frame: 1 year
the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLC1101 monotherapy
RP2D
Time frame: 1.5 years
the recommended phase II dose of QLC1101 monotherapy
2 secondary outcomes
Preliminary efficacy endpoints
Time frame: 3 years
Preliminary efficacy endpoints
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLC1101 in people with Non-small Cell Lung Cancer and Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd. at 5 sites 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 25 days after the first dose). The study lists 3 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 8 May 2024.