RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma
A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma
About This Trial
This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma
Who May Be Eligible (Plain English)
Who May Qualify:• diagnosed by tissue sample (biopsy-confirmed) locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). Patients who have progressed or relapsed after at least 1st-line systemic standard therapy.
- Male or non-pregnant, non-lactating female subjects aged ≥18 years.
- You should be able to carry out daily activities with 0 level of ability (ECOG 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 willing to sign a consent form form.
- Consent to provide archived tissue specimen or tissue sample.
Who Should NOT Join This Trial:• 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.
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:• Histologically or cytologically confirmed locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). Patients who have progressed or relapsed after at least 1st-line systemic standard therapy.
* Male or non-pregnant, non-lactating female subjects aged ≥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.
* 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:• 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.
* 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.
Treatments Being Tested
DRUG
PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day
Locations (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China