Advanced Solid Tumors Harboring MAPK Pathway AlterationsPhase 1NCT05488821
Safety, Tolerability and Pharmacokinetics Study of QLH11906 in Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations.
A Phase 1 study testing QLH11906 in people with Advanced Solid Tumors Harboring MAPK Pathway Alterations, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is an open label, phase 1 clinical study to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in patients with relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathway, and determine the Maximum Tolerated Dose (MTD) or Maximum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors Harboring MAPK Pathway Alterations
- What is being tested?
- QLH11906
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2022to 1 Jul 2025
- Phase
- Phase 1
- 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
- The subjects participated voluntarily, signed the informed consent, and were able to abide by the research procedures.
- Subjects with advanced (metastatic or unresectable) solid tumors with histologically confirmed MAPK signaling pathway alteration.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Subjects are able to swallow and retain oral medication without any clinically significant gastrointestinal abnormalities that alter absorption.
- Subjects (including women and men) agree to use effective contraception for contraception from the time of signing the informed consent form to 180 days after the last use of the study drug. Female subjects of childbearing age cannot be pregnant or breastfeeding.
Who cannot join
- Subjects received systemic anticancer therapy within 2 weeks prior to the first dose.
- Subjects received radical radiotherapy within 4 weeks before the first administration, or received local palliative radiotherapy for bone metastases within 1 week.
- Subjects who have received inhibitors or inducers of CYP3A4 within 1 week before the first dose; or within 5 half-lives of the drug; or subjects who need to continue to receive these drugs during the study period.
- Active bacterial, fungal, or viral infection requiring systemic therapy within 1 week prior to the first dose.
- Subjects with symptomatic central nervous system (CNS) metastases and/or cancerous meningitis.
- Cardiovascular and cerebrovascular diseases with clinical significance.
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- Clinically uncontrollable serous effusion (eg, pleural effusion that cannot be controlled by drainage or other methods).
- Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.
- Known immediate or delayed hypersensitivity reactions or idiosyncratic reactions to the investigational treatment-related chemotherapeutic drugs and their excipients.
- Human immunodeficiency virus (HIV) positive test result and Treponema pallidum antibody positive.
- Hepatitis B virus surface antigen (HBsAg) positive and viral deoxyribonucleic acid (HBV DNA) > 2000 IU/ml or 104 copies/ml (only the centers that can perform qualitative examination, the HBV DNA test result is positive or high detection limit); hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive.
- Other malignant tumors occurred within 2 years before study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)
- Pregnant or lactating women.
- Any pre-existing serious or unstable disease (except for the above-mentioned malignant tumors), mental disease or any disease or medical condition that the investigator considers may interfere with the subject's safety, obtaining informed consent, or complying with research procedures.
- Concurrent participation in other clinical trials using experimental therapies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital
Shandong
Jinming Yu, MD,PhD, 0531-67626971, sdyujinming@126.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Oral Pan-RAF Inhibitor QLH11906 in Subjects With Advanced Solid Tumors Harboring MAPK Pathway Alterations.
This is an open label, phase 1 clinical study to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in patients with relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathway, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD, if MTD cannot be determined) and Recommended Dose in Phase II Clinical Studies (Recommended Phase II Dose, RP2D).
- Being tested
- QLH11906
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLH11906Drug
QLH11906 only
| Study group | Role | What they receive |
|---|---|---|
| QLH11906 | Experimental | QLH11906 Tablets Receives: Drug: QLH11906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD/MAD
The Maximum Tolerated Dose (MTD) will be determined during dose escalation using a Bayesian Optimal Interval (BOIN) design.The maximum administrated dose (MAD) is defined as the highest dose of all groups if MTD can not be determined.
Measured: Up to 24 approximately months
RP2D
Recommended dose for phase II trials
Measured: Up to 24 approximately months
Secondary outcomes (6)
Adverse Events (AEs) /Serious Adverse Events (SAEs)
Measured: Up to 24 approximately months
Area under the concentration-time curve（AUC）
Pharmacokinetic (PK) parameters of QLH11906 monotherapy, including Area under the concentration-time curve（AUC）
Measured: Up to 24 approximately months
Overall response rate (ORR)
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including objective response rate(ORR).
Measured: Up to 24 approximately months
Duration of response (DoR)
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including duration of response(DOR).
Measured: Up to 24 approximately months
Disease control rate (DCR)
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including disease control rate(DCR).
Measured: Up to 24 approximately months
Maximum concentration (Cmax)
Pharmacokinetic (PK) of QLH11906 monotherapy, including Maximum concentration (Cmax)
Measured: Up to 24 approximately months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start14 Jun 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors Harboring MAPK Pathway AlterationsStudies 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
- 40 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
- NCT05488821
- Sponsor's protocol ID
- QLH11906-101
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. 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 and Pharmacokinetics of the Oral Pan-RAF Inhibitor QLH11906 in Subjects With Advanced Solid Tumors Harboring MAPK Pathway Alterations.
- ClinicalTrials.gov ID
- NCT05488821
- Acronym / sponsor ID
- QLH11906-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 5 Aug 2022 (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 is an open label, phase 1 clinical study to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in patients with relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathway, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD, if MTD cannot be determined) and Recommended Dose in Phase II Clinical Studies (Recommended Phase II Dose, RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLH11906 | Experimental | Drug: QLH11906QLH11906 Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects participated voluntarily, signed the informed consent, and were able to abide by the research procedures.
- Subjects with advanced (metastatic or unresectable) solid tumors with histologically confirmed MAPK signaling pathway alteration.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Subjects are able to swallow and retain oral medication without any clinically significant gastrointestinal abnormalities that alter absorption.
- Subjects (including women and men) agree to use effective contraception for contraception from the time of signing the informed consent form to 180 days after the last use of the study drug. Female subjects of childbearing age cannot be pregnant or breastfeeding.
Key exclusion criteria (15 listed)
- Subjects received systemic anticancer therapy within 2 weeks prior to the first dose.
- Subjects received radical radiotherapy within 4 weeks before the first administration, or received local palliative radiotherapy for bone metastases within 1 week.
- Subjects who have received inhibitors or inducers of CYP3A4 within 1 week before the first dose; or within 5 half-lives of the drug; or subjects who need to continue to receive these drugs during the study period.
- Active bacterial, fungal, or viral infection requiring systemic therapy within 1 week prior to the first dose.
- Subjects with symptomatic central nervous system (CNS) metastases and/or cancerous meningitis.
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 |
|---|---|---|
| QLH11906QLH11906 only | Drug | QLH11906 |
Primary outcome
MTD/MAD
Time frame: Up to 24 approximately months
The Maximum Tolerated Dose (MTD) will be determined during dose escalation using a Bayesian Optimal Interval (BOIN) design.The maximum administrated dose (MAD) is defined as the highest dose of all groups if MTD can not be determined.
RP2D
Time frame: Up to 24 approximately months
Recommended dose for phase II trials
6 secondary outcomes
Adverse Events (AEs) /Serious Adverse Events (SAEs)
Time frame: Up to 24 approximately months
Area under the concentration-time curve（AUC）
Time frame: Up to 24 approximately months
Overall response rate (ORR)
Time frame: Up to 24 approximately months
Duration of response (DoR)
Time frame: Up to 24 approximately months
Disease control rate (DCR)
Time frame: Up to 24 approximately months
Maximum concentration (Cmax)
Time frame: Up to 24 approximately months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLH11906 in people with Advanced Solid Tumors Harboring MAPK Pathway Alterations, run by Qilu Pharmaceutical 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 15 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 5 Aug 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lianghua Fang (86-13645192882, lianghua.fang@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD/MAD (time frame: Up to 24 approximately months). 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 5 Aug 2022.