Solid TumorPhase 1NCT06086522
Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors
A Phase 1 study testing QN-302 in people with Solid Tumor, run by Qualigen Theraputics, Inc. at 4 sites in United States.
Trial summary
Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer). Main questions: What does the study drug do to human body (Pharmacodynamics [='PD']) What does the body do to study drug (how processed in body (Pharmacokinetics [='PK']) - Safety Study drug by intravenous infusion ('IV') once… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- QN-302
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2023to Dec 2026
- 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 locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy 2. Evaluable or measurable disease by RECIST 1.1
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Abigail VanKirk, 616-389-1824
Abigail VanKirk, 616.389.1824, abigail.vankirk@startmidwest.com
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77002
Jordi Rodon, MD
- Not yet recruiting
Yale
New Haven, Connecticut, 06520
Patricia LoRusso, DO
- Recruiting
HonorHealth
Scottsdale, Arizona, 85251
Andrew Islas, 833-354-6667
anislas@honorhealth.com
About this study
Official title: A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors
Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer).
Main questions:
- What does the study drug do to human body (Pharmacodynamics [='PD'])
- What does the body do to study drug (how processed in body (Pharmacokinetics [='PK']) - Safety
Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.
- Conditions
- Solid Tumor
- Being tested
- QN-302
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QN-302Drug
Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Starting dose in Phase 1a dose escalation Receives: Drug: QN-302 |
| Cohort 2 | Other | 2nd cohort in Phase 1a dose escalation Receives: Drug: QN-302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine MTD
maximum tolerated dose identified from dose escalation cohorts
Measured: 18 months
Establish RP2D
recommended Phase 2 dose identified from dose escalation cohorts
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 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.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Dose escalation, Dose expansion
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualigen Theraputics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Responsible party
- Sponsor
- Investigators
- Tariq Arshad, MD, Study director, Qualigen Theraputics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086522
- Sponsor's protocol ID
- 302P1V01
- Status last verified
- Apr 2024
- First submitted
- 11 Oct 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06086522
- Acronym / sponsor ID
- 302P1V01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Qualigen Theraputics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Oct 2023 (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.
Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer).
Main questions:
- What does the study drug do to human body (Pharmacodynamics [='PD'])
- What does the body do to study drug (how processed in body (Pharmacokinetics [='PK']) - Safety
Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation, Dose expansion
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: QN-302Starting dose in Phase 1a dose escalation |
| Cohort 2 | Other | Drug: QN-3022nd cohort in Phase 1a dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy 2. Evaluable or measurable disease by RECIST 1.1
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| QN-302Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Determine MTD
Time frame: 18 months
maximum tolerated dose identified from dose escalation cohorts
Establish RP2D
Time frame: 24 months
recommended Phase 2 dose identified from dose escalation cohorts
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 1 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Tariq Arshad, MD study director
Qualigen Theraputics, Inc.
4 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 QN-302 in people with Solid Tumor, run by Qualigen Theraputics, Inc. at 4 sites in United States.
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 1 inclusion and 1 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 1 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 4 sites in United States. 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?
Contact Tariq Arshad, MD (use email, clinicaltrials@qlgntx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine MTD (time frame: 18 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 1 May 2024.