A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma
NCT ID: NCT06727630
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2024-03-14
2025-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Monotherapy Escalation / Monotherapy Backfill
Dose escalation arm with PRJ1-3024 which will begin with 3-6 subjects treated at the lowest planned dose level based on previous phase Ia study results. PRJ1-3024 is administered orally once daily. The starting dose is 300mg/day.
After the small dose escalation, one or two dose backfill group will be tested to further explore the efficacy and safety of China patients with unresectable local advanced or metastatic melanoma.
PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ECOG Performance Status 0\~1.
* Has at least 1 measurable lesion as defined by RECIST 1.1 criteria.
* Life expectancy of ≥3 months, in the opinion of the Investigator.
* Able to take oral medications and willing to record daily adherence to investigational product.
* Adequate hematologic parameters.
* Adequate renal and hepatic function
* Able to understand and willing to sign a written informed consent form.
* Consent to provide archived tissue specimen or tissue sample.
Exclusion Criteria
* Significant cardiovascular disease.
* Known active HBV, HCV, AIDS-related illness.
* Has received a live vaccine within 30 days.
* History of active autoimmune disorders, or ongoing immunosuppressive therapy.
* Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< Grade 2.
* Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
* Prior treatment with other hematopoietic progenitor kinase 1 (HPK1) inhibitors.
* Allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhuhai Yufan Biotechnologies Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hui Ouyang, Dr.
Role: STUDY_DIRECTOR
VP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jun Guo, Dr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRJ1-3024-003
Identifier Type: -
Identifier Source: org_study_id