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Tests treatment safety and results for Advanced Solid Tumor
Official title A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05315167
What this study is testing
What is PRJ1-3024?
PRJ1-3024 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Key
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available...
- Male or non-pregnant, non-lactating female people age ≥18 years.
- ECOG Performance Status 0\~1.
- Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
You likely can't join if
- History of another malignancy
- Known symptomatic brain metastases requiring \>10 mg/day of prednisolone.
- 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 or ongoing .
See the full eligibility criteria
- \- Key
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
- Male or non-pregnant, non-lactating female people age ≥18 years.
- 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 unless clearly due to the disease under study.
- Adequate renal and hepatic function
- Able to understand and willing to sign a written informed consent form. Key
- History of another malignancy
- Known symptomatic brain metastases requiring \>10 mg/day of prednisolone.
- 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 or ongoing .
- 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 hematopoietic progenitor kinase 1 (HPK1) inhibitors.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Chengdu, Sichuan, China; Hangzhou, Zhejiang, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.