Recruiting
Phase 1 / Phase 2
A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma
About this study
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
- Condition
- Melanoma
- Tested
- PRJ1-3024
- Sponsor
- Zhuhai Yufan Biotechnologies Co., Ltd
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 18 years
- Study condition: Melanoma
- 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 9
- 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.
Where
1 site, 1 recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Contact
-
Liting Lai, Bachelor
8617728075858 vivi.lai@ming-med.com
Potential match only. Final eligibility is determined by the study team.