Health TrialsbyHealthPanel

A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma

ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhuhai Yufan Biotechnologies Co., Ltd

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • PRJ1-3024

    Drug

    PRJ1-3024 is provided as capsules and is administered orally once a day

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Monotherapy Escalation / Monotherapy BackfillExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.

Time frame
24 months
2

Recommended phase 2 dose (RP2D)

To determine the RP2D in China advanced metastatic melanoma patients

Time frame
24 months

Secondary outcomes

1

Duration of response (DOR)

Defined as time from the first occurrence of a documented objective response to the time of relapse or death from and cause.

Time frame
24 months
2

Progression-Free Survival (PFS)

Calculated from the start of treatment until the first occurrence of disease progression or death, whichever comes first.

Time frame
24 months
3

Disease control rate (DCR)

To access the response of patients, particularly whether the treatment is able to shrink or stabilize the tumor.

Time frame
24 months
4

Pharmacokinetic parameters (PK)

Peak Plasma Concertration(Cmax)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhuhai Yufan Biotechnologies Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now